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CTRI Number  CTRI/2023/01/048971 [Registered on: 13/01/2023] Trial Registered Prospectively
Last Modified On: 15/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to assess the effect of a Unani formulation in the gel form and medicated steam form in patients of Knee Osteoarthritis. 
Scientific Title of Study   Comparative Clinical Evaluation of Unani Formulation in redesigned gel form with its classical Bukhoor form in the Management of Knee Osteoarthritis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nishat Khursheed 
Designation  PI ( MD-Scholar)) 
Affiliation  Jamia Hamdard (Deemed to be University),New-Delhi 
Address  Dept. of Moalajat,School of Unani Medical Education and Research, Jamia Hamdard, New-Delhi(South)
Dept. of Moalajat,School of Unani Medical Education and Research, Jamia Hamdard, New-Delhi(South)
South
DELHI
110062
India 
Phone  9520088300  
Fax    
Email  drnishatamu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Azhar Jabin 
Designation  Associate Professor 
Affiliation  Jamia Hamdard (Deemed to be University),New-Delhi 
Address  Dept. of Moalajat,School of Unani Medical Education and Research, Jamia Hamdard, New-Delhi(South)
Dept. of Moalajat,School of Unani Medical Education and Research, Jamia Hamdard, New-Delhi(South)
South
DELHI
110062
India 
Phone  9899315252  
Fax    
Email  ajabin@jamiahamdard.ac.in  
 
Details of Contact Person
Public Query  
Name  Azhar Jabin 
Designation  Associate Professor 
Affiliation  Jamia Hamdard (Deemed to be University),New-Delhi 
Address  Dept. of Moalajat,School of Unani Medical Education and Research, Jamia Hamdard, New-Delhi(South)
Dept. of Moalajat,School of Unani Medical Education and Research, Jamia Hamdard, New-Delhi(South)
South
DELHI
110062
India 
Phone  9899315252  
Fax    
Email  ajabin@jamiahamdard.ac.in  
 
Source of Monetary or Material Support  
Jamia Hamdard (Deemed to be university), New-Delhi 
 
Primary Sponsor  
Name  Jamia Hamdard university 
Address  Hamdard Nagar, New Delhi,110062 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Azhar Jabin  Majeedia Unani Hospital  Majeedia Unani Hospital, Jamia Hamdard, New Delhi
New Delhi
DELHI 		 26059687

ajabin@jamiahamdard.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jamia Hamdard Institutional Ethics Committee (JHIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, (2) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bukhoor (Medicated steam of unani drugs)  the comparator will be the Unani formulation, in the form of medicated steam (Bukhoor)to be locally applied on Knee joint in the patients of Knee OA for one month. 
Intervention  Unani formulation  the intervention will be the Unani formulation, in the form of gel to be locally applied on Knee joint in the patients of Knee OA, twice daily for one month.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Patients of Knee OA according to American College of Rheumatology (ACR) criteria
Clinical classification criteria plus radiographic findings (X-ray) for knee osteoarthritis.
1.Pain in for most days of the prior month and ‘one’ of the following three
 Morning stiffness ≤30 minutes duration.
 Age 40 to 65 years.
 Crepitus on active knee movement
2.Presence of Osteophytes on knee Radiograph.
• Patients with pain intensity score of 3 cm or
more on a 10 cm visual analog scale (VAS).
• Willingness and ability to accept intervention and to comply with the requirements of the protocol.
 
 
ExclusionCriteria 
Details  × Pregnant and lactating females.
× Severely ill patients.
× History of significant trauma, infection or
presence of hematoma at the site of knee and/or
knee surgery.
× History of other musculoskeletal disorders.
× Known case of malignancy.
× Patients taking NSAID’s and corticosteroids, (a
wash out period of 1week and 4 weeks
respectively is required before enrolling
patient).
× Unwilling to participate in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale (VAS) for pain.
KOOS (Knee injury and OA outcome score) for pain, stiffness, functions in daily living, function in sports and recreational activities, quality of life and other symptoms.
4-Point Likert Scale (0-3) for joint tenderness.
Knee circumference for swelling of knee joint.
Range of movements (ROM).
 		 Baseline, Ist Wk, 2nd wk, 3rd wk, 4th wk and 5th wk (treatment free wk). 
 
Secondary Outcome  
Outcome  TimePoints 
Response of patient to the therapy on a 5-point Likert Scale (0-4) by patient’s Global Assessment (PGA).
Response of investigator to the therapy on a 5-point Likert Scale (0-4) Investigator’s Global Assessment (IGA).
SF-12 for quality-of-life assessment.
 		 4 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   16/01/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 16-01-2023 and end date provided 29-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

The clinical study entitled “Comparative clinical evaluation of Unani formulation in redesigned gel form with classical Bukhoor form in the management of knee osteoarthritis” is carried out in OPD/IPD of Majeedia Unani hospital, Jamia Hamdard, New Delhi. The study is approved by the IEC, Jamia Hamdard. It is interventional, open, randomized, comparative control study of duration 1 ½ years and of 4 weeks protocol therapy with a total sample size of 40 patients and 20 in each group. The objective of this study is to redesign and develop gel form of the Unani formulation and to study its efficacy and safety in the management of knee osteoarthritis. The effect of this gel is to be compared with its bukhoor form (medicated steam) in pain management and also to assess the overall improvement in the quality of life in patients of knee osteoarthritis. The total 40 patients will be randomized into two groups. Gel form of the Unani formulation is to be given to the patients of group A for local application twice a day (4 grams of gel for 1 knee joint in one time for 4 weeks) and bukhoor will be given to the patients of group B for four weeks (medicated steam will be performed once daily for first 5 days in 1st week, 3 times alternatively in 2nd week and 2 times in 3rd and 4th week in the hospital. All the male and female, Knee OA patients, aged 40 to 65 years, with pain, morning stiffness ≤30 minutes duration, crepitus on active movement and presence of osteophytes on knee radiograph and with pain intensity score of 3 cm or more on a 10 cm on VAS and willing to accept the intervention and complying with the protocol will be included.  Patients taking NSAID’s and corticosteroids, a wash out period of 1week and 4 weeks respectively, is required before enrolling such patients. The patients will be assessed at day 0 and every week for 1 month and the data will be collected and recorded in CRF. The assessment parameters for screening and safety are CBC with ESR, LFT & KFT,  X- ray Knee AP and lateral view.  The parameters for the assessment of efficacy   are VAS, KOOS, ROM, knee circumference, skin temperature over knee, tenderness on 4-Point Likert Scale. Response of the patient and the investigator to the therapy on a 5-point Likert Scale (0-4) by PGA and IGA respectively. The quality-of-life will be assessed by SF-12. Adverse effects if any will be immediately recorded and action will be taken in consultation with the physician. The decision for inclusion or exclusion will be taken on interest of the patient. The same will be reported to Institutional Ethics Committee. All the data will be compiled and the results will be analyzed after appropriate statistical application.  

 

 

 

 
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