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CTRI Number  CTRI/2021/08/035633 [Registered on: 13/08/2021] Trial Registered Prospectively
Last Modified On: 12/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To see the prevalence of Knee osteoarthritis and to evaluate the effect of Hijamah bila Shart (Dry Cupping) in the cases of Knee osteo-arthritis. 
Scientific Title of Study   Prevalence of knee osteoarthritis and efficacy of hijamah bila shart in its management: a hospital based study 
Trial Acronym  MD/TST/2018-21 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mod Akram 
Designation  Associate Professor and Head of the Department 
Affiliation  Jamia Hmadard 
Address  Department of Tahaffuzi wa Samaji Tibb, SUMER
Hamdard Nagar
South
DELHI
110062
India 
Phone  9891928622  
Fax    
Email  makram@jamiahamdard.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mod Akram 
Designation  Associate Professor and Head of the Department 
Affiliation  Jamia Hmadard 
Address  SUMER
Hamdard Nagar
South
DELHI
110062
India 
Phone  9891928622  
Fax    
Email  makram@jamiahamdard.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Mohd Salman 
Designation  MD Scholar 
Affiliation  Jamia Hmadard 
Address  SUMER
Hamdard Nagar
South
DELHI
110062
India 
Phone  9911987304  
Fax    
Email  mdsalmanqasmi@gmail.com  
 
Source of Monetary or Material Support  
Majeedia Unani Hospital, SUMER, Jamia Hamdard 
 
Primary Sponsor  
Name  Jamia Hamdard  
Address  Hamdard Nagar New Delhi. 110062 
Type of Sponsor  Other [Deemed to be University] 
 
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 Mohd Salman  Majeedia Unani Hospital  Room No. 10,Jamia Hamdard, Hamdard Nagar, New Delhi-110062
South
DELHI 
9911987304

mdsalmanqasmi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Jamia Hamdard  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Habbe Suranjan along with Hijamah bila Shart  In group B, besides Hijamah therapy same as in Group A, patient will also be given Habbe Suranjan, 2 tablets twice a day orally for 4 weeks. 
Intervention  Hijamah bila Shart (Dry Cupping)  In group A Hijamah bila Shart will be performed in the procedure section of the IBT OPD. The patient will be asked to lie down on procedure table in supine position with their affected knee flexed and then 3 Hijamah cups of equal size will be applied (diameter of cups 5cm, depth 5.5cm and volume 70ml) with the help of suction pump anteriomedially, anteriolaterally and anterio superiorly (above the base of patella) near the articular edge of femur, for 10 minutes. This procedure will be repeated twice a week for 4 weeks. Assessment of safety and efficacy will be done at each follow up till completion of the study, that is on28th day. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  •Diagnosed patients of knee OA in age groups of 35 to 65 years.
•Subjective pain intensity of 5mmto 74mm (mild to moderate pain) baseline on Visual Analogue Scale (VAS).
•Grade 2and grade 3 osteoarthritis in X-ray film. (Kellgren and Lawrence)
•Clinically stable patients.
•ESR<40mm/hr
•Rheumatoid factors (RF)<1:40
•Patients of all genders.
•Patients who are willing to sign the informed consent form and participate in the trial voluntarily.
 
 
ExclusionCriteria 
Details  •Age below 35 and above 65.
•ESR > 40mm/hr.
•Rheumatoid factors (RF)>1:40
•< Grade 2 and >grade 3osteoarthritis in X-ray film.(Kellgren and Lawrence)
•Patients with uncontrolled DM, Hepatic, Renal or CVS disorders.
•Patient on anticoagulant therapy or Haemophiliacs
•Pregnant and lactating mothers.
•Subjects who are chronically ill patient with infectious diseases like AIDS and Tuberculosis etc.
•Patients who fail to give written consent.
•Patients taking analgesic or anti-inflammatory drugs for any other disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale (VAS)
Knee Injury And Osteoarthritis Outcome Score (KOOS)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Index (Modified – CRD Pune Version)
 
Baseline, 28th day 
 
Secondary Outcome  
Outcome  TimePoints 
Prevalence of Knee OA in the total number of patients reporting at the registration counter of the Hospital  At the end of three months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   16/08/2021 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   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 - NO
Brief Summary  

Besides psychosocial effects of osteoarthritis, the economic burden is extremely high, including direct costs related to drugs, medical care and hospitalization. This burden is largely attributed to the effects of the disability which causes loss of work days and mental stress indirectly. The available treatment options include NSAIDs which havebeen reportedto cause gastropathy, renal and hepatic toxicities, and increasing CVD risk on prolonged use (Goldstein, et al., 2015)

Furthermore, among the chronic rheumatic diseases, knee osteoarthritis (OA) is the most prevalent and is a leading cause of pain and disability in most countries worldwide. Its prevalence increases with age and generally affects women more frequently than men. OA is strongly associated with aging and heavy physical occupational activity, a required livelihood for many people living in rural communities in developing countries. Determining region-specific OA prevalence will provide important information for planning future cost-effective preventive strategies and health care services.

There is no prevalence present about knee osteoarthritis in Unani System of Medicine. Although in Unani Medicine, the effectiveness of Hijama­h-bila-shart (dry cupping) in the management of Knee OA is time tested, however, the data concerning the effectiveness of hijamah-bila-shart (dry cupping) without concurrent use of oral or topical drugs are infrequent. Hence, there is a need to create research-based evidence for validation ofthe effectiveness of Hijama­h-bila-shart and to determine the prevalence of knee osteoarthritis in patients visiting OPD of Ilaj-Bil-Tadbeer in Majeedia Unani Hospital.

 
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