<?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>IRCT20171112037401N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-01</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences ,Vice chancellor for research</primary_sponsor>
      <public_title>Comparison of the Effect of "Herbal Ointment " with" Methyl Salicylate Ointment " in patients with knee arthritis</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effect of "Herbal ointment (Ginger, Black Pepper and Rose)" with "Methyl Salicylate ointment" on Improving pain and functional disorders in patients with knee arthritis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27681</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Herbal medicine design with Iranian medicine approach, Randomization description: Simple randomization, Blinding description: The  participant - investigator - the outcome evaluation - the outcome of the safety committee and the data monitoring committee  do not   know what kind of ointment.</study_design>
      <phase>3</phase>
      <hc_freetext>Knee Osteoarthritis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: prescribing herbal ointment containing the juice of three plants:  pepper, cinnamon, and roses with equal ratio in  a base of animal oil lubricant  base, will  give to  three doses  daily for two months. Ointment  is made at the Mashhad  Faculty of Traditional  Medicine. Intervention 2: Intervention group 2: Methyl salicylate ointment 30 g (each 100 g contain 15 g of methyl salicylate and 10 g of menthol) made by Sobhan-Dar company is given in three daily doses for two months.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>the results showed that the pain variable in the vegetation group was decreased from ( 1 / 45 / 45 ) to 42 / 35 / 4 ) and the intensity of pain was decreased from ( 1 / 1 f / 3 ) to ( 11 / 1 / 12 ) . In the METHYL  SALICYLATE ointment consumer group , the pain variable ( 81 ± 55 ± 77 / 8 ) was reduced to ( ± 1.0 ± 2 ± 7 / 7 ) and the intensity of the pain variable ( 89 ± 0.6 ± 85 ) and the pain intensity variable ( 99 ± 0.6 ± 55 ) to 71 ± 1.0 ± 1 / 4 ) . Therefore the test result was significant for all three variables ( 00 / 00 P ) . On the other hand ,On the other hand , according to Fisher 's careful examination of pain and the use of herbal ointment   as well as a synthetic ointment was positive (p= 001 /0) However , no significant relationship was observed when using   METHYL  SALICYLATE ointment ( 07 / p = p ) . In fact , the reduction in pain is the positive effect of drug  ointment on the intensity and intensity of pain , which was significant at the same time in all three groups ; but in the group using herbal ointment ( pain and intensity of pain 3 ) , it was ranked And in the group using METHYL  SALICYLATE ointment , it had the last rank ( pain of 2 units and intensity of pain close to 1 unit ) In terms of descriptive statistics , in fact , in the compound group 13 out of 20 people finally preferred the use of herbal ointment . It is not expected that the result of the test in all three meaningful groups is not unexpected because the nature of METHYL  SALICYLATE was decreased in pain and in line with our study , but it was important to the researcher of the value and effect size , which had less influence than herbal ointment . 
According to researchers from other research banks , it is not found to compare the effect of herbal ointment with methyl salicylate (  Comparison of housing effect effect of ginger and pepper and roses with methyl salicylate ) , so the use of this ointment may also be effective in reducing the pain and intensity of pain . But if this study is carried out in larger sample volumes and in larger treatment centers and by other researchers on patients with different conditions , these findings will be reliable and reliable . Conclusion based on the findings of this study , topical application of  herbal ointment  introduced in this study reduces pain and severity of people knee pain compared to  METHYL  SALICYLATE , so it is advisable to use this ointment in the pharmaceutical industry after studies and further research .
Table 1 : Comparison of the effect of  METHYL  SALICYLATE ointment and herbal ointment on pain and intensity of pain
variables group     frequency             mean    deviation of the test     result
 herbal ointment    pain prior to use   40           45/8                              17/1
group     	variables                         frequency    mean      deviation            result
                                                                                           of the test
herbal ointment	
Pain before use	                                40	       8/45	1/17	        0/00
Pain After Use	                                40	      4/35	        1/42	
The intensity of pain before using	40	      7/40	        1/19	
The intensity of pain after using	        40	      3/12	        1/11	
Changes in pain grade	                        40	      -4/10	 0/98	
Changes to pain intensity score	        40	      -4/28	 1/21	
METHYL  SALICYLATE	
Pain before use	                                40	       8/55	 0/81	         0/00
Pain After Use	                                40	       6/77	 1/02	
The intensity of pain before using	40	       7/85	 0/89	
The intensity of pain after using	        40	       7/20	 1/09	
Changes in pain grade	                        40	      -1/77	 0/97	
Changes to pain intensity score	        40	      -0/65	 0/69	
Use both oitment  at the same time	
Pain before use	                                40	       8/60	 0/94	        0/00
Pain After Use	                                40	       5/55	 1/57	
The intensity of pain before using	40	       7/55	 0/99	
The intensity of pain after using	        40	       4/10	 1/71	
Changes in pain grade	                        40	      -3/05	 0/88	
Changes to pain intensity score	        40	      -3/45	 1/66</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 The investigation has not been done</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Sabbaghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shirudi street 16-18The Center for Health17shahrivar</address>
        <city>Mashad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9167763643</zip>
        <telephone>+98 51 3364 7827</telephone>
        <email>sabbaghim2@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammadreza Noras</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad University of Medical Sciences -Mashhad Faculty of Traditional Medicine</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>norasmr@mums.ac.i</zip>
        <telephone>+98 51 3855 2189</telephone>
        <email>norasmr@mums.ac.ir</email>
        <affiliation>Mashhad Faculty of Traditional Medicine</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Symptomatic primary osteoarthritis in knee approved
by clinical or radiological criteria
Pain: Score over 40 (Visual Scale)
Age: 60 - 80 years</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient dissatisfaction 
Drug use
Patients treated with hormonal drugs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>m17.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gonarthrosis</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 1: prescribing herbal ointment containing the juice of three plants:  pepper, cinnamon, and roses with equal ratio in  a base of animal oil lubricant  base, will  give to  three doses  daily for two months. Ointment  is made at the Mashhad  Faculty of Traditional  Medicine.</i_keyword>
      <i_keyword>Intervention group 2: Methyl salicylate ointment 30 g (each 100 g contain 15 g of methyl salicylate and 10 g of menthol) made by Sobhan-Dar company is given in three daily doses for two months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Joint stiffness. Timepoint: Two weeks after start the treatment, then every two weeks for two months. Method of measurement: WOMAC questionnaire.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Two weeks after start the treatment, then every two weeks for two months. Method of measurement: The VAS criterion.</prim_outcome>
      <prim_outcome>Physical action. Timepoint: Two weeks after start the treatment, then every two weeks for two months. Method of measurement: WOMAC questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Dissatisfaction. Timepoint: Two weeks after start the treatment, then every two weeks for two months. Method of measurement: Discontinue the treatment.</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 ,Vice chancellor for research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-15</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>University Avenue, Building Qureshi, research and technology Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
