| CTRI Number |
CTRI/2023/07/055240 [Registered on: 14/07/2023] Trial Registered Prospectively |
| Last Modified On: |
17/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative clinical study to check the effect of Dry Cupping and Isometric Knee Exercise in Knee Osteoarthritis |
|
Scientific Title of Study
|
A Comparative clinical study to demonstrate the effect of Hijama-bila-Shart(Dry Cupping) and Isometric Knee Exercise in Knee Osteoarthritis (WAJA-UR-RUKBA) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shah Adnan Rasheed |
| Designation |
P.G. Scholar |
| Affiliation |
State Unani Medical College Prayagraj |
| Address |
Department of Ilaj bit Tadbeer State Unani Medical College Prayagraj Uttar Pradesh
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
9760084077 |
| Fax |
|
| Email |
shahadnan05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Anisur Rahman |
| Designation |
Head of the Department |
| Affiliation |
State Unani Medical College Prayagraj |
| Address |
Department of Ilaj bit Tadbeer State Unani Medical College Prayagraj Uttar Pradesh
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
9452550358 |
| Fax |
|
| Email |
hkmarahman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shah Adnan Rasheed |
| Designation |
P.G. Scholar |
| Affiliation |
State Unani Medical College Prayagraj |
| Address |
Department of Ilaj bit Tadbeer State Unani Medical College Prayagraj Uttar Pradesh
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
9760084077 |
| Fax |
|
| Email |
shahadnan05@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College Prayagraj Ministry of Ayush Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College, Prayagraj, Ministry of Ayush, U.P Govt |
| Address |
Department of Ilaj bit Tadbeer State Unani Medical College Prayagraj Uttar Pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Shah Adnan Rasheed |
State Unani Medical College |
Department of Ilaj bit Tadbeer State Unani Medical College Prayagraj Uttar Pradesh
Allahabad
UTTAR PRADESH |
9760084077
shahadnan05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee State Unani Medical College and Hospital Prayagraj |
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 |
| Intervention |
Hijama-bila-Shart (Dry Cupping) |
Four medium sized (5.5cm diameter) cups would be applied on each affected knee joint in such a manner that one cup medially above the knee joint, 2nd cup medially below the joint line, 3rd cup laterally above the joint line and 4th cup laterally below the joint line. Negative pressure inside the cups would be created by drawing 3-4 suctions and allowed to remain adhere to the site upto 12-15 minutes.
This is will performed for 14 days alternately. |
| Comparator Agent |
Isometric Knee Exercise |
Isometric exercises on daily on basis for 15 minutes with three repetitions at interval of 5 minutes for a period of 28 days. They are followed up on 7th, 14th, 21st and 28th day. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Radiologically diagnosed patients of knee Osteoarthritis. 2. Both genders. 3. Age between 40-70 years. |
|
| ExclusionCriteria |
| Details |
1. Pregnancy and lactation. 2. Uncontrolled Diabetes Mellitus and Hypertension. 3. Other form of arthritis (Rheumatoid arthritis etc.). 4. Patient with history of trauma and accident involving knee joint. 5. Concomitant skin disease at the application site. 6. Patients taking analgesic drugs, steroidal treatment and hormonal therapy. |
|
|
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 |
VAS
KOOS |
0, 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Knee Osteoarthritis Outcome Score |
0, 28 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/07/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pain in joints is a major clinical problem since ancient times. Inflammatory or non inflammatory joint disorders have been described elaborately by eminent Unani Physicians under one caption of Waja ul mafasil, which stands for pain in joints. On the basis of clinical presentation, osteoarthritis looks very similar to Waja-ul-Mafasil Balghami. One of the most common form of osteoarthritis is knee osteoarthritis, which can be translated as Waja-ur-Rukba. Osteoarthritis is a chronic painful disorder, primarily treated with non-steroidal anti inflammatory drugs(NSAIDS) and corticosteroids that have a large number of adverse effects on various organs of the body. While the Unani system of medicine and physiotherapy has multi-directional approach for the management of knee osteoarthritis. Because of these problems, a device evolving non-drug management of disease has always been welcomed and appreciated. Hijama is one such method used in Unani system of medicine to manage a number of disease including Waja-ur-Rukba. It has been described in the classical literature to be effective and that too without any chance of producing side effects. On the other hand exercise also increases the functional ability of joints and thus reduces the pain perception. Strengthening of the hamstring and quadricep muscle is important for reduction in knee osteoarthritis and improving the range of motion and decrease the limitations of functional performance of patients with knee osteoarthritis. |