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
|
|
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
|
|
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 HijamaÂh-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 HijamaÂh-bila-shart and to determine the prevalence of knee osteoarthritis in patients visiting OPD of Ilaj-Bil-Tadbeer in Majeedia Unani Hospital. |