<?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>IRCT20230202057310N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-12-25</date_registration>
      <primary_sponsor>Muhammad  Institute  of  Medical  and  Allied  Sciences,  Multan,  Pakistan.</primary_sponsor>
      <public_title>Habb-e- Asgand and Isometric Exercises in Rheumatoid Arthritis Management</public_title>
      <acronym></acronym>
      <scientific_title>Synergistic Effects of Habb-e- Asgand and Isometric Exercises in Rheumatoid Arthritis Management</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-01-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80755</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation concealment occurs and patients will be recruited by using simple randomization through the Lottery method. lottery method carried out through sealed envelopes, Blinding description: Statistical analyser and outcome asessor will be kept blind so that the result obtained will be without biasness.Participants will be blinded. Both  will be unaware of the type of treatments that will be evaluated after the completion of the intervention trial and they will be kept blind by not knowing about the effects and group detail.</study_design>
      <phase>1</phase>
      <hc_freetext>Rheumatoid Arthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Group A:  will be given 1 tablet (500 mg) of Habb-e-Asgand, twice daily after meals, with lukewarm water for 12 weeks. Intervention 2: Intervention group: Group B: will be treated with Isometric Exercise Intervention  including quadriceps and hamstring isometric contractions (10-second holds, 10–15 repetitions per set), grip-strengthening exercises (squeezing a stress ball for 5–10 seconds, repeated 10–15 times).Each session lasts 30–40 minutes, with a focus on individual tolerance and gradual progression. Intervention 3: Intervention group: Group C will be given combined Intervention, participants will follow both the Habb-e-Asgand regimen and isometric exercise protocol as described above.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is N/A</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maliha Khalid Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bosan Road</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 312 6827130</telephone>
        <email>malihatareen1997@gmail.com</email>
        <affiliation>Muhammad  Institute  of  Medical  and  Allied  Sciences,  Multan,  Pakistan.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Imran Ahmad Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Old shuja Abad road Multan</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>66000</zip>
        <telephone>+92 333 6120602</telephone>
        <email>imran.ahmad@mnsuam.edu.pk</email>
        <affiliation>Muhammad Nawaz Sharif University of Agriculture, Multan, Pakistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adults (aged 25–60 years) diagnosed with rheumatoid arthritis (RA) based on ACR/EULAR 2010 classification criteria
Active disease symptoms with mild to moderate RA severity
Ability to follow an exercise regimen
Adherence to treatment.
Patients with swelling in joints and pain</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severe or end-stage RA requiring surgical intervention
Known allergies to herbal products or ingredients in Habb-e-Asgand
Recent use of immunosuppressive drugs, other experimental therapies, or specific physiotherapy regimens.
Pregnancy
Lactation</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M05</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Rheumatoid arthritis with rheumatoid factor</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Group A:  will be given 1 tablet (500 mg) of Habb-e-Asgand, twice daily after meals, with lukewarm water for 12 weeks</i_keyword>
      <i_keyword>Intervention group: Group B: will be treated with Isometric Exercise Intervention  including quadriceps and hamstring isometric contractions (10-second holds, 10–15 repetitions per set), grip-strengthening exercises (squeezing a stress ball for 5–10 seconds, repeated 10–15 times).Each session lasts 30–40 minutes, with a focus on individual tolerance and gradual progression</i_keyword>
      <i_keyword>Intervention group: Group C will be given combined Intervention, participants will follow both the Habb-e-Asgand regimen and isometric exercise protocol as described above.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: 12 weeks. Method of measurement: WOMAC and NPRS scale.</prim_outcome>
      <prim_outcome>Stiffness. Timepoint: 12 weeks. Method of measurement: WOMAC scale.</prim_outcome>
      <prim_outcome>Daily activities. Timepoint: 12 weeks. Method of measurement: WOMAC scale.</prim_outcome>
      <prim_outcome>Disease activity score. Timepoint: 12 weeks. Method of measurement: Disease Activity Score (DAS28).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Decrease in inflammatory biomarkers. Timepoint: 12 weeks. Method of measurement: ESR, CRP, RF.</sec_outcome>
      <sec_outcome>Rheumatoid Arthritis Disability. Timepoint: 12 weeks. Method of measurement: Rheumatoid Arthritis Disability Index (RADI).</sec_outcome>
      <sec_outcome>Swollen Joint Count. Timepoint: 12 weeks. Method of measurement: Xrays.</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>Muhammad  Institute  of  Medical  and  Allied  Sciences,  Multan,  Pakistan.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-12-10</approval_date>
        <contact_name>The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences,</contact_name>
        <contact_address>Multan MULTAN Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
