<?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>IRCT20220614055167N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-25</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Efficacy and safety of Turmeric, Black Seeds, Flaxseed and Medicago Sativa in patients with osteoarthritis</public_title>
      <acronym></acronym>
      <scientific_title>The Joint Effects of Turmeric, Black Seeds, Flaxseed and Medicago Sativa for relieving symptoms of knee osteoarthritis: A Phase 1-2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66296</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using balanced block randomization, patients will be enrolled in one of the two groups, intervention (mixed cream of turmeric, flax seeds, Medicago Sativa, and black seeds) or placebo. The randomization sequence will be performed by an individual who will not participate in the current study. Moreover, the aforementioned randomization method reduces the chances of predicting and manipulating the randomization process and will lead to balanced sample sizes in both groups, both during the study and at the end of the study. The patients will all receive sealed boxes that are numbered with 10-digit codes and contain either the intervention or placebo creams, Blinding description: The patients will receive the boxes sealed with 10-digit codes and in the container of the original drug or placebo, and they will not be aware of the type of drug received, and the researcher will ensure the blinding of the patients. Also, doctors, researchers, and those responsible for the implementation of the project will not be aware of the type of medicine received by the patients until the end of the study.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Knee osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa. Intervention 2: Control group: Vaseline cream.</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 no additional information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeid Safiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi St., Golgasht Ave., Tabriz University of Medical Sciences</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165665931</zip>
        <telephone>+98 41 3332 7195</telephone>
        <email>saeidsafiri@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeid Safiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadi St., Golgasht Ave., Tabriz University of Medical Sciences</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5165665931</zip>
        <telephone>+98 41 3332 7195</telephone>
        <email>saeidsafiri@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least 6 months of diagnosis of knee osteoarthritis, and whose OA diagnosis meets the American College of Rheumatology criteria
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale baseline value of ≥ 9 (0-20 scale)
Functional Capacity Classification of I-III
Radiograph evidence of OA in the target knee with a Kellgren-Lawrence score of 2 or 3
Morning stiffness of &lt;30 min duration or crepitus on active motion, which is present upon examination</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Evidence of other conditions or diseases of the skin or joints
Evidence of partial or complete knee joint replacement or anticipated joint replacement in the target knee
Contraindications to the use of non-steroidal anti-inflammatory drugs (NSAIDs) or who use anticoagulant therapy that prohibits them from using NSAIDs
Pregnancy, planning to become pregnant or breastfeeding during the study period
Ischemic heart disease, heart failure, end-stage cirrhosis, end-stage renal failure, or psychiatric conditions that prevent an adequate evaluation of the study outcomes
Insufficient cognitive functioning to participate and complete the questionnaires
Unable or unwilling to follow up and complete the study pathway,
A history or diagnosis of other arthritic conditions, such as rheumatoid arthritis, joint and bone deformities, fibromyalgia and/or other inflammatory and immune system disorders
Type I or II diabetes or obesity (body mass index ≥ 39)
Suffering from painful conditions or frequent headaches requiring the use of systemic opiates or derivatives, or the need for additional NSAID or COX-2 inhibitors
Receiving systemic or intra-articular corticosteroid injections.
Having active cancer undergoing treatment that prevents the evaluation of the outcome measures</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M17.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Osteoarthritis of knee, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa</i_keyword>
      <i_keyword>Control group: Vaseline cream</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Joint pain. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index pain, joint stiffness and physical function subscales.</prim_outcome>
      <prim_outcome>Joint stiffness. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index pain, joint stiffness and physical function subscales.</prim_outcome>
      <prim_outcome>Physical function. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index pain, joint stiffness and physical function subscales.</prim_outcome>
      <prim_outcome>Overall Western Ontario and McMaster Universities Osteoarthritis score. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index.</prim_outcome>
      <prim_outcome>Subjective Global Evaluation (SGE). Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Subjective Global Evaluation forms.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Evaluation of patient’s quality of life, which will be measured using the 36-Item Short Form Survey which produces Mental Component and Physical Component scores.</sec_outcome>
      <sec_outcome>Quality of sleep. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: The quality of sleep, which will be measured using the Pittsburgh Sleep Quality Index.</sec_outcome>
      <sec_outcome>Functional Capacity Classification. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Functional Capacity Classification will be evaluated using a 4-point Likert scale and will be evaluated by the doctor and placed into 4 classes (Class I-IV), which range from full functional capacity to disabled.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-01-09</approval_date>
        <contact_name>Ethics committee of Tabriz University of Medical Sciences</contact_name>
        <contact_address>Azadi St., Golgasht Ave., Tabriz University of Medical Sciences Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
