<?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>IRCT20220514054846N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-26</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Oral melatonin effect on pain after percutaneous lumbar disc decompression: a double-blind randomized clinical trial</public_title>
      <acronym>PLDD</acronym>
      <scientific_title>Oral melatonin Effect on pain  after percutaneous lumbar disc decompression</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-28</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73471</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: It was done as Random Allocation Block by (Random Allocation Software 2.0)  in groups of 10 people, Blinding description: Patients qrouping will not record in the file, so the physition who perform the procedure and whom examine in the clinic will not aware of the patients qrouping also they are not involve in the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Oral Melatonin effect on pain and disability after percutaneous disc decompression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  patients in trial group, will take 3 mg melatonin tablets in addition to drugs belong to control group. The drugs will register electronically and Medicines are prepared from the  Rasool Aakram Hospital pharmacy. The patient does not pay the cost of the melatonin drug and the cost is paid to the pharmacy by researcher separatly . In this way, the drug producing company is same in all patients. Intervention 2: Control group:After PLDD patients will receive Diclofenac,pregsbaline and vitamin B1by electronic prescription.Drugs will be taken from  Rasool Aakram Hospital pharmacy and drugs brand and company are the same in all patients.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Participants data can be shared

When:
starting one year after complete of study

To whom:
ِData will be shared for academic institutions.

Conditions:
The reason of needding data must be determine with detail.

Where to obtain:
fatemehmorssali@yahoo.com

How to obtain:
Up to one month after request they can receive data.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyedeh Fatemeh Morsal</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasool Acram Pain Research Center Niayesh street,Sattarkhan ave,tehan</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6435 2326</telephone>
        <email>fatemehmorssali@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Morsali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pain Research center of Rasool Acram hospital,Niayesh street,Sattar khan ave,Tehran city</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6435 2326</telephone>
        <email>fatemehmorssali@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Unilateral or bilateral chronic radicular low back pain.
Moderate to high pain score (VAS 3 or higher).
Confirmation of LDH in one to three lumbar levels based on MRI and physical examination findings.
ASA class I-II.
No respond to conservative treatments (at least for three months)</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Include disc extrusion or sequestration.
Disc height reduction of more than 50%.
Severe spinal deformity.
Tumor or spinal fracture or spondylolisthesis.
Local or systemic infection.
Use of anticoagulants.
History of allergic reaction to study drugs.
Pregnancy and breastfeeding.
Severe disorders.
Sudden onset of neurological deficit such as urinary and fecal incontinence.
History of lumbar spine surgery.
Peripheral neuropathy.
Patient refusal.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  patients in trial group, will take 3 mg melatonin tablets in addition to drugs belong to control group. The drugs will register electronically and Medicines are prepared from the  Rasool Aakram Hospital pharmacy. The patient does not pay the cost of the melatonin drug and the cost is paid to the pharmacy by researcher separatly . In this way, the drug producing company is same in all patients.</i_keyword>
      <i_keyword>Control group:After PLDD patients will receive Diclofenac,pregsbaline and vitamin B1by electronic prescription.Drugs will be taken from  Rasool Aakram Hospital pharmacy and drugs brand and company are the same in all patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Determining the effect of oral melatonin on patients  pain relief  after lumbar disc decompression by SLR physical examination degree in intervention and control groups that will done by pain fellowship in pain clinic in specific time. Timepoint: 0,2 week,2nd month.3rd month. Method of measurement: Physical examination and determination SLR degree by pain fellowship in specific time.</prim_outcome>
      <prim_outcome>Determining the effect of oral melatonin on patients  pain relief by  ( Oswestry Disability Index) using questionnaire that complete by pain fellowship. Timepoint: 0,2 week,2nd month.3rd month. Method of measurement: Determination of McGill pain index using questionnaire that complete by pain fellowship.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-28</approval_date>
        <contact_name>Iran university of ethics committee</contact_name>
        <contact_address>Rasool acam pain research center,4th step,department no 2.shr arar street,. tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
