<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20230626058585N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-31</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of adding acupuncture to standard care in patients with fatty liver disease</public_title>
      <acronym></acronym>
      <scientific_title>To investigate the effect of acupuncture plus standard care with standard care alone for liver chemistries and metabolic, systemic markers in adults with nonalcoholic fatty liver disease or metabolic dysfunction associated steatotic liver disease.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/92159</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be individually allocated to the intervention and control groups in a 1:1 ratio using permuted block randomization with variable block sizes of 4 and 6. No stratification will be used. The random allocation sequence will be generated using the Sealed Envelope online randomization service. Allocation concealment will be performed using opaque, sealed envelopes prepared by an independent person who is not involved in delivering the intervention or assessing the outcomes. After confirming eligibility and obtaining written informed consent, the next envelope in the predetermined order will be opened and the participant will be assigned to the indicated group, Blinding description: Due to the nature of the intervention, participants and the acupuncturist will not be blinded. The clinical outcome assessor, laboratory personnel handling coded samples, telephone safety monitor, ultrasonography reader, data-entry personnel, and statistical analyst will remain blinded to group allocation. The telephone safety monitor will receive a coded list containing participants from both groups without group labels. Participants will be instructed not to disclose their group allocation or type of intervention during blinded assessments or telephone calls, and any unblinding will be documented. Group codes will be revealed only after completion of the primary statistical analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Metabolic dysfunction associated steatotic liver disease (nonalcoholic fatty liver disease).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: During weeks 1 to 6, participants in this group will receive standard conventional care for non-alcoholic fatty liver disease/metabolic dysfunction-associated steatotic liver disease plus manual acupuncture. Standard care, prescribed by a gastroenterology and hepatology specialist, includes at least 30 minutes of aerobic exercise on 5 days per week and dietary advice to reduce caloric intake and, when clinically indicated, carbohydrate and/or fat intake. Adherence, medication changes, treatments outside the protocol, and barriers to adherence will be assessed weekly during weeks 1 to 6. When non-adherence is identified, a standardized reminder will be provided and documented. Manual acupuncture will be administered at the Acupuncture Clinic of Imam Reza Hospital in 12 sessions over 6 weeks, comprising 2 sessions per week and 30 minutes per session. A total of 32 needles will be used in each session: the bilateral points BL-17, BL-18, BL-19, BL-20, LR-13, LR-14, LR-3, LI-11, SP-6, SP-9, SP-10, KI-3, PC-6, ST-36, and ST-40, and the midline points CV-6 and CV-12. Sterile, disposable stainless-steel needles measuring 0.25 × 40 mm will be used. After achieving De qi, manual tonification using gentle clockwise rotation and low-amplitude lifting and thrusting will be performed. Needle stimulation will be applied briefly at the beginning of the session and, if required, once more before needle removal. Electroacupuncture will not be used. Before each acupuncture session, the participant’s general condition, dizziness or syncope, anticoagulant use, and the skin at the intended needling sites will be assessed. An intervention-specific two-part safety checklist will be completed at each of the 12 acupuncture sessions. It will include a closed question regarding common or uncommon needling-related adverse events and an open question regarding any new symptom or sign. Independently of adherence monitoring and session-specific safety assessment, from the start of week 1 through the end of week 18, participants in both groups will receive a structured weekly safety telephone call with the same script, duration, and two-part safety checklist. The closed question will assess adverse or unwanted events and changes in health status since the preceding contact, and the open question will assess any new symptom or sign. Calls will be conducted by a safety monitor blinded to group allocation using a coded participant list without group labels. These calls are not a continuation of protocol-defined standard care. Week 18 is a follow-up and outcome-assessment timepoint only. Routine medications are permitted and will be recorded. Acupuncture, moxibustion, or cupping outside the study protocol will not be permitted during the study. Intervention 2: Control group: During weeks 1 to 6, participants in the control group will receive standard conventional care alone for non-alcoholic fatty liver disease/metabolic dysfunction-associated steatotic liver disease, according to the recommendations of a gastroenterology and hepatology specialist. Standard care includes at least 30 minutes of aerobic exercise, such as brisk walking, on 5 days per week and dietary recommendations to reduce caloric intake and, according to each participant’s clinical condition, carbohydrate and/or fat intake. Adherence, medication changes, treatments outside the protocol, and barriers to adherence will be assessed and documented weekly during weeks 1 to 6. When non-adherence is identified, a standardized reminder will be provided and documented. Participants in this group will not receive acupuncture as part of the study. Independently of adherence monitoring, from the start of week 1 through the end of week 18, participants in the control group will receive the same structured weekly safety telephone calls as the intervention group, with the same script, duration, timing, and two-part safety checklist. The closed question will assess adverse or unwanted events and changes in health status since the preceding contact, and the open question will assess any new symptom or sign. Calls will be conducted by a safety monitor blinded to group allocation using a coded participant list without group labels. These calls are not a continuation of protocol-defined standard care. Week 18 is a follow-up and outcome-assessment timepoint only. Routine medications and any treatment changes will be recorded. Acupuncture, moxibustion, or cupping outside the study protocol will not be permitted during the study.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is currently no plan to make deidentified individual participant data publicly available because public data sharing is not included in the approved informed consent process and participant confidentiality must be protected. Scientifically justified requests may be considered after completion of the study, subject to approval by the principal investigator and the research ethics committee and in accordance with Mashhad University of Medical Sciences regulations.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyed Kazem Farahmand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Persian and Complementary medicine, Campus of Ferdowsi University, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9138813944</zip>
        <telephone>+98 51 3884 8930</telephone>
        <email>farahmandk1@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Kazem Farahmand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Persian and Complementary medicine, Campus of Ferdowsi University, Azadi Square</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9138813944</zip>
        <telephone>+98 51 3884 8930</telephone>
        <email>farahmandk1@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of MASLD/NAFLD based on clinical, laboratory, and imaging criteria by a gastroenterologist/hepatologist.
Grade 2 or 3 hepatic steatosis on baseline B-mode ultrasonography.
Age 18 years or older.
Clinically stable condition without acute hepatitis, acute liver failure, or current hospitalization for an acute liver condition.
Stable main disease-related treatments without major changes during the previous 4 to 6 weeks, according to the treating physician.
Ability to attend all scheduled study visits and follow-up assessments and, if allocated to the intervention group, the acupuncture sessions.
Willingness to participate and provision of written informed consent.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Grade 0 or 1 hepatic steatosis on baseline ultrasonography according to the protocol-defined criteria, because only participants with grade 2 or 3 steatosis are eligible for this study.
Evidence of cirrhosis, advanced hepatic fibrosis, liver failure, or hepatic decompensation.
Other causes of liver disease, including active viral hepatitis, autoimmune hepatitis, biliary disease, Wilson disease, or hemochromatosis.
Significant alcohol consumption exceeding 20 g/day in women or 30 g/day in men.
Use of potent anticoagulants such as warfarin or direct oral anticoagulants, or severe coagulopathy making acupuncture unsafe.
Severe thrombocytopenia or another bleeding disorder preventing safe needling.
History of severe hypersensitivity or marked intolerance to needling, or extensive skin lesions at the intended acupuncture sites.
Pregnancy or breastfeeding.
Advanced malignancy or an incurable systemic disease with a life expectancy of less than 6 months.
Regular acupuncture treatment for a related condition during the previous 3 months.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Fatty (change of) liver, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: During weeks 1 to 6, participants in this group will receive standard conventional care for non-alcoholic fatty liver disease/metabolic dysfunction-associated steatotic liver disease plus manual acupuncture. Standard care, prescribed by a gastroenterology and hepatology specialist, includes at least 30 minutes of aerobic exercise on 5 days per week and dietary advice to reduce caloric intake and, when clinically indicated, carbohydrate and/or fat intake. Adherence, medication changes, treatments outside the protocol, and barriers to adherence will be assessed weekly during weeks 1 to 6. When non-adherence is identified, a standardized reminder will be provided and documented. Manual acupuncture will be administered at the Acupuncture Clinic of Imam Reza Hospital in 12 sessions over 6 weeks, comprising 2 sessions per week and 30 minutes per session. A total of 32 needles will be used in each session: the bilateral points BL-17, BL-18, BL-19, BL-20, LR-13, LR-14, LR-3, LI-11, SP-6, SP-9, SP-10, KI-3, PC-6, ST-36, and ST-40, and the midline points CV-6 and CV-12. Sterile, disposable stainless-steel needles measuring 0.25 × 40 mm will be used. After achieving De qi, manual tonification using gentle clockwise rotation and low-amplitude lifting and thrusting will be performed. Needle stimulation will be applied briefly at the beginning of the session and, if required, once more before needle removal. Electroacupuncture will not be used. Before each acupuncture session, the participant’s general condition, dizziness or syncope, anticoagulant use, and the skin at the intended needling sites will be assessed. An intervention-specific two-part safety checklist will be completed at each of the 12 acupuncture sessions. It will include a closed question regarding common or uncommon needling-related adverse events and an open question regarding any new symptom or sign. Independently of adherence monitoring and session-specific safety assessment, from the start of week 1 through the end of week 18, participants in both groups will receive a structured weekly safety telephone call with the same script, duration, and two-part safety checklist. The closed question will assess adverse or unwanted events and changes in health status since the preceding contact, and the open question will assess any new symptom or sign. Calls will be conducted by a safety monitor blinded to group allocation using a coded participant list without group labels. These calls are not a continuation of protocol-defined standard care. Week 18 is a follow-up and outcome-assessment timepoint only. Routine medications are permitted and will be recorded. Acupuncture, moxibustion, or cupping outside the study protocol will not be permitted during the study.</i_keyword>
      <i_keyword>Control group: During weeks 1 to 6, participants in the control group will receive standard conventional care alone for non-alcoholic fatty liver disease/metabolic dysfunction-associated steatotic liver disease, according to the recommendations of a gastroenterology and hepatology specialist. Standard care includes at least 30 minutes of aerobic exercise, such as brisk walking, on 5 days per week and dietary recommendations to reduce caloric intake and, according to each participant’s clinical condition, carbohydrate and/or fat intake. Adherence, medication changes, treatments outside the protocol, and barriers to adherence will be assessed and documented weekly during weeks 1 to 6. When non-adherence is identified, a standardized reminder will be provided and documented. Participants in this group will not receive acupuncture as part of the study. Independently of adherence monitoring, from the start of week 1 through the end of week 18, participants in the control group will receive the same structured weekly safety telephone calls as the intervention group, with the same script, duration, timing, and two-part safety checklist. The closed question will assess adverse or unwanted events and changes in health status since the preceding contact, and the open question will assess any new symptom or sign. Calls will be conducted by a safety monitor blinded to group allocation using a coded participant list without group labels. These calls are not a continuation of protocol-defined standard care. Week 18 is a follow-up and outcome-assessment timepoint only. Routine medications and any treatment changes will be recorded. Acupuncture, moxibustion, or cupping outside the study protocol will not be permitted during the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Change in serum alanine aminotransferase level. Timepoint: At baseline before the intervention and at the end of week 6 after the start of the intervention. Method of measurement: Serum alanine aminotransferase will be measured in units per liter by a standard enzymatic laboratory method using an automated clinical chemistry analyzer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Change in serum aspartate aminotransferase level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum aspartate aminotransferase will be measured in units per liter in the central laboratory using a standard kinetic enzymatic method and an automated clinical chemistry analyzer.</sec_outcome>
      <sec_outcome>Change in serum alkaline phosphatase level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum alkaline phosphatase will be measured in units per liter in the central laboratory using a standard enzymatic method and an automated clinical chemistry analyzer.</sec_outcome>
      <sec_outcome>Change in serum gamma glutamyl transferase level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum gamma glutamyl transferase will be measured in units per liter in the central laboratory using a standard enzymatic method and an automated clinical chemistry analyzer.</sec_outcome>
      <sec_outcome>Change in serum albumin level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum albumin will be measured in grams per deciliter in the central laboratory using a standard colorimetric method and an automated clinical chemistry analyzer.</sec_outcome>
      <sec_outcome>Change in serum total bilirubin level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum total bilirubin will be measured in milligrams per deciliter in the central laboratory using a standard colorimetric method and an automated clinical chemistry analyzer.</sec_outcome>
      <sec_outcome>Change in prothrombin time. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Plasma prothrombin time will be measured in seconds using a standard coagulation assay and an automated coagulation analyzer.</sec_outcome>
      <sec_outcome>Change in international normalized ratio. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: The international normalized ratio will be calculated from the participant's prothrombin time, the laboratory control prothrombin time, and the international sensitivity index of thromboplastin using the standard formula.</sec_outcome>
      <sec_outcome>Change in fasting blood glucose level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Fasting plasma glucose will be measured in milligrams per deciliter after an overnight fast using a standard enzymatic laboratory method and an automated clinical chemistry analyzer.</sec_outcome>
      <sec_outcome>Change in glycated hemoglobin level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Blood glycated hemoglobin will be measured as a percentage using a standardized laboratory method and an automated analyzer.</sec_outcome>
      <sec_outcome>Change in fasting serum insulin level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Fasting serum insulin will be measured in micro-international units per milliliter using a standardized immunoassay and an automated immunoassay analyzer.</sec_outcome>
      <sec_outcome>Change in the homeostatic model assessment of insulin resistance score. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: The homeostatic model assessment of insulin resistance score will be calculated by multiplying fasting serum insulin in micro-international units per milliliter by fasting plasma glucose in milligrams per deciliter and dividing the result by 405.</sec_outcome>
      <sec_outcome>Change in serum triglyceride level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum triglyceride will be measured in milligrams per deciliter in the central laboratory using a standard enzymatic colorimetric method and an automated clinical chemistry analyzer.</sec_outcome>
      <sec_outcome>Change in serum total cholesterol level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum total cholesterol will be measured in milligrams per deciliter in the central laboratory using a standard enzymatic colorimetric method and an automated clinical chemistry analyzer.</sec_outcome>
      <sec_outcome>Change in serum high-density lipoprotein cholesterol level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum high-density lipoprotein cholesterol will be measured in milligrams per deciliter in the central laboratory using a standard laboratory method and an automated clinical chemistry analyzer.</sec_outcome>
      <sec_outcome>Change in serum low-density lipoprotein cholesterol level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum low-density lipoprotein cholesterol will be determined in milligrams per deciliter in the central laboratory using its standard validated laboratory procedure.</sec_outcome>
      <sec_outcome>Change in serum thyroid-stimulating hormone level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum thyroid-stimulating hormone will be measured in milli-international units per liter using a standardized immunoassay and an automated immunoassay analyzer.</sec_outcome>
      <sec_outcome>Change in serum high-sensitivity C-reactive protein level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum high-sensitivity C-reactive protein will be measured in milligrams per liter using a standardized high-sensitivity immunoassay and an automated analyzer.</sec_outcome>
      <sec_outcome>Change in the fibrosis four index score. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: The fibrosis four index will be calculated using the following formula: age in years multiplied by serum aspartate aminotransferase in units per liter, divided by the product of platelet count in ten to the ninth power per liter and the square root of serum alanine aminotransferase in units per liter.</sec_outcome>
      <sec_outcome>Change in liver steatosis grade assessed by ultrasonography. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Liver steatosis will be assessed by B-mode abdominal ultrasonography using the same ultrasound device and a trained operator at all three assessments. Images will be coded and de-identified and will be read by an ultrasonography reader blinded to group allocation and the temporal order of the images. Steatosis will be classified from grade 0 to grade 3 based on hepatic echogenicity and visualization of the intrahepatic vessels, diaphragm, and posterior part of the right hepatic lobe.</sec_outcome>
      <sec_outcome>Change in the physical health domain score of the World Health Organization Quality of Life Brief Version questionnaire. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: The validated Persian 26-item World Health Organization Quality of Life Brief Version questionnaire will be administered by a blinded outcome assessor. The physical health domain score will be calculated according to the standard scoring instructions and transformed to a scale from zero to 100, with higher scores indicating better quality of life.</sec_outcome>
      <sec_outcome>Change in the psychological health domain score of the World Health Organization Quality of Life Brief Version questionnaire. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: The validated Persian 26-item World Health Organization Quality of Life Brief Version questionnaire will be administered by a blinded outcome assessor. The psychological health domain score will be calculated according to the standard scoring instructions and transformed to a scale from zero to 100, with higher scores indicating better quality of life.</sec_outcome>
      <sec_outcome>Change in the social relationships domain score of the World Health Organization Quality of Life Brief Version questionnaire. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: The validated Persian 26-item World Health Organization Quality of Life Brief Version questionnaire will be administered by a blinded outcome assessor. The social relationships domain score will be calculated according to the standard scoring instructions and transformed to a scale from zero to 100, with higher scores indicating better quality of life.</sec_outcome>
      <sec_outcome>Change in the environment domain score of the World Health Organization Quality of Life Brief Version questionnaire. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: The validated Persian 26-item World Health Organization Quality of Life Brief Version questionnaire will be administered by a blinded outcome assessor. The environment domain score will be calculated according to the standard scoring instructions and transformed to a scale from zero to 100, with higher scores indicating better quality of life.</sec_outcome>
      <sec_outcome>Change in body weight. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Body weight will be measured in kilograms using a calibrated scale, with the participant wearing light clothing and no shoes.</sec_outcome>
      <sec_outcome>Change in body mass index. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Body mass index will be calculated as body weight in kilograms divided by the square of height in meters. Height will be measured at baseline using a stadiometer.</sec_outcome>
      <sec_outcome>Change in platelet count. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Platelet count will be measured in ten to the ninth power per liter as part of the complete blood count using an automated hematology analyzer.</sec_outcome>
      <sec_outcome>Change in blood hemoglobin concentration. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Blood hemoglobin concentration will be measured in grams per deciliter as part of the complete blood count using an automated hematology analyzer.</sec_outcome>
      <sec_outcome>Change in total white blood cell count. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Total white blood cell count will be measured in ten to the ninth power per liter as part of the complete blood count using an automated hematology analyzer.</sec_outcome>
      <sec_outcome>Change in serum sodium level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum sodium will be measured in millimoles per liter in the central laboratory using the ion-selective electrode method and an automated electrolyte analyzer.</sec_outcome>
      <sec_outcome>Change in serum urea level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum urea will be measured in milligrams per deciliter in the central laboratory using a standard enzymatic method and an automated clinical chemistry analyzer.</sec_outcome>
      <sec_outcome>Change in serum creatinine level. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum creatinine will be measured in milligrams per deciliter in the central laboratory using a standard laboratory method and an automated clinical chemistry analyzer.</sec_outcome>
      <sec_outcome>Incidence of adverse events during the study. Timepoint: Throughout the 18-week study period; during every acupuncture session for the intervention group and at all scheduled contacts and follow-up visits for both groups. Method of measurement: Adverse events will be actively assessed at each contact and recorded on a standardized adverse event form. The number and proportion of participants experiencing at least one adverse event will be calculated for each study group.</sec_outcome>
      <sec_outcome>Severity of adverse events during the study. Timepoint: Throughout the 18-week study period; during every acupuncture session for the intervention group and at all scheduled contacts and follow-up visits for both groups. Method of measurement: Each recorded adverse event will be classified by the investigator as mild, moderate, or severe according to its clinical intensity and the need for medical intervention. The distribution of severity categories will be reported for each study group.</sec_outcome>
      <sec_outcome>Change in serum alanine aminotransferase level. Timepoint: At baseline before the intervention and at the week 18 follow-up after the start of the intervention. Method of measurement: Serum alanine aminotransferase will be measured in units per liter by a standard enzymatic laboratory method using an automated clinical chemistry analyzer.</sec_outcome>
      <sec_outcome>Change in systolic blood pressure. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Systolic blood pressure will be measured in millimeters of mercury after at least 5 minutes of rest using a standard clinical method. The same measurement method used at baseline will be repeated at weeks 6 and 18.</sec_outcome>
      <sec_outcome>Change in diastolic blood pressure. Timepoint: At baseline before the intervention, at the end of week 6, and at the week 18 follow-up after the start of the intervention. Method of measurement: Diastolic blood pressure will be measured in millimeters of mercury after at least 5 minutes of rest using a standard clinical method. The same measurement method used at baseline will be repeated at weeks 6 and 18.</sec_outcome>
      <sec_outcome>Total number of adverse events during the study. Timepoint: Throughout the 18-week study period; during every acupuncture session for the intervention group and at all scheduled weekly telephone contacts and follow-up visits for both groups. Method of measurement: All adverse events will be actively assessed and recorded on a standardized adverse event form. Each distinct adverse event will be counted separately, allowing more than one event per participant. The total number of adverse events will be calculated for each study group.</sec_outcome>
      <sec_outcome>Seriousness of adverse events during the study. Timepoint: Throughout the 18-week study period; during every acupuncture session for the intervention group and at all scheduled weekly telephone contacts and follow-up visits for both groups. Method of measurement: Each recorded adverse event will be classified as serious or non-serious. A serious adverse event is an event resulting in death, a life-threatening condition, hospitalization or prolongation of hospitalization, persistent or significant disability, a congenital anomaly, or another medically important event. The number and proportion of serious adverse events will be reported for each study group.</sec_outcome>
      <sec_outcome>Timing of adverse events during the study. Timepoint: Throughout the 18-week study period; during every acupuncture session for the intervention group and at all scheduled weekly telephone contacts and follow-up visits for both groups. Method of measurement: For each adverse event, the date or study week of onset, date or study week of resolution, and its temporal relationship to an acupuncture session or scheduled study contact, when applicable, will be recorded on the standardized adverse event form.</sec_outcome>
      <sec_outcome>Relationship of adverse events to the study intervention. Timepoint: Throughout the 18-week study period; during every acupuncture session for the intervention group and at all scheduled weekly telephone contacts and follow-up visits for both groups. Method of measurement: The relationship of each adverse event to the study intervention will be assessed by the investigator using a standardized causality assessment and classified as unrelated, unlikely, possible, probable, or definite. The distribution of causality categories will be reported for each study group.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-08-10</approval_date>
        <contact_name>Ethics Committee of Imam Reza Hospital, Mashhad University of Medical Sciences</contact_name>
        <contact_address>Imam Reza Clinical Research Development Unit, Educational Complex Building, Basement Floor, Imam Reza Hospital, Ebne Sina Street, Mashhad, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
