| CTRI Number |
CTRI/2024/02/062496 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| 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
|
Clinical trial to study the effectiveness of a unani formation, Habb-e-Mafasil, in Primary Knee Osteoarthritis. |
|
Scientific Title of Study
|
Clinical study to evaluate the therapeutic safety and efficacy of Habb-e-Mafasil in the management of Waja’al- Rukba (Primary Knee
Osteoarthritis): An open label block randomized standard control study.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zaffar Hussain |
| Designation |
Professor and HOD Department of Moalajat |
| Affiliation |
Regional Research Institute Of Unani Medicine (RRIUM) Srinagar |
| Address |
Department of Moalajat RRIUM Srinagar Naseem Bagh Campus of University Of Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006021996 |
| Fax |
|
| Email |
hussainzaffar6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Zaffar Hussain |
| Designation |
Professor and HOD Department of Moalajat |
| Affiliation |
Regional Research Institute Of Unani Medicine (RRIUM) Srinagar |
| Address |
Department of Moalajat RRIUM Srinagar Naseem Bagh Campus of University Of Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006021996 |
| Fax |
|
| Email |
hussainzaffar6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Andleeb Razaq |
| Designation |
PG Scholar |
| Affiliation |
Regional Research Institute Of Unani Medicine (RRIUM) Srinagar |
| Address |
Department of Moalajat RRIUM Srinagar Naseem Bagh Campus University Of Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
6006016918 |
| Fax |
|
| Email |
parrayandleebrazaq@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research In Unani Medicine New Delhi |
| Address |
Regional Research Institute of Unani Medicine (RRIUM), University of Kashmir Srinagar, CCRUM New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 Zaffar Hussain |
Regional Research Institute Of Unani Medicine Srinagar |
Moalajat OPD-1, Ground Floor, Department Of Moalajat, RRIUM, Naseembagh Campus University of Kashmir Hazratbal
Srinagar
JAMMU & KASHMIR |
7006021996
hussainzaffar6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research,RRIUM Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Mafasil (Tablet) |
Its a classical unani formulation from the book Al-Qarabadein. It consists of equal quantities of 8 individual drugs -Suranjan Talakh (Colchicum lutium Linn),Aelwa (Aloe barbadensis Mill),Turbud Safed (Ipomoea turpethum Linn),Sana Maki (Cassia angustifolia Linn) Afsanteen (Artmisia absinthium Linn),Namak Sambhar (Lake salt), Shaham Hanzal (Citrulus colocynthis Linn),Ajmood (Apium graveolens Linn).2 tablets of 500mg each will be given to the patient thrice a day for 28 days. |
| Comparator Agent |
Tab Glucosamine Sulphate |
Tab Glucosamine Sulphate 1500mg will be given to the patient once a day for 28 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients irrespective of gender in the age group of 20 to 65 years will be included. clically and radiologically diagnosed patients with kellegren-lawrence grades 1,2 and 3 and with BMI less than 35 kg per meter square. patients who have agreed to sign the informed consent form and are willing to follow up as per the study protocol. |
|
| ExclusionCriteria |
| Details |
1. Kellgren- Lawrence grade 4 knee osteoarthritis.
2. Pregnant and Lactating women.
3. BMI more than 35kg per meter square.
4. History of recent knee infection.
5. Prior knee surgery.
6. Prior bone disease such as Osteomyelitis
7. Prior trauma to the knee joint.
8. Patients having received intra-articular knee injection as that of corticosteroids or hyaluronic acid or any investigational drug in the past one month.
9. Known cases of inflammatory joint disease as Rheumatoid Arthritis.
10. Patients with history of any significant systemic diseases like cardiovascular, gastrointestinal, renal, hepatic.
11. Patients with uncontrolled diabetes mellitus and hypertension.
12. Patients who refuse to give the written consent for the study and unwillingness to come for regular follow up as described in the study plan. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pain in knee joint.
2. Stiffness in knee joint after inactivity.
3. Restriction of joint movements.
4. Swelling either with or without effusion.
5. Crepitus
6. Tenderness |
At day 0, 14 and 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| X Ray bilateral knee joints AP and Lateral |
day 0 and 28 |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "89"
Final Enrollment numbers achieved (India)="89" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
03/10/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Osteoarthritis is the most common musculoskeletal disease in the world after lower back ache. It stems from cartilage degeneration at joint sites which leads to significant pain and disability. Among all forms of arthritis, isolated knee osteoarthritis is the most common progressive multifactorial joint disease. It accounts for almost four fifths of the burden of osteoarthritis worldwide and increases with obesity and age. The global prevalence of knee osteoarthritis in individuals aged 15 and over is about 16.0% and 22.9% in individuals aged 40 and over. Correspondingly there are around 654.1 million individuals (40 years and older) with knee osteoarthritis in 2020 worldwide. In females the risk of both prevalence and incidence is higher than males. However, with ageing of the population, both the prevalence of osteoarthritis and the amount of disability associated with it have been increasing worldwide, especially in developed countries where the life expectancy has increased. Along with the pain and stiffness in joints, OA leads to joint deformities also. Despite all these complications, OA is often neglected either because it’s not a fatal disease or many physicians consider it to be a normal part of ageing and is not inherently treatable. This, however, results in vast direct medical costs and significant loss of work. It is the leading indication for total joint replacement. Presently there is no definite cure for osteoarthritis nor are there any pharmacological agents available that definitely affect the underlying pathological process. The disease is usually treated by giving Non steroidal anti-inflammatory drugs like Selective cox1 and cox2 inhibitors, corticosteroids etc that are aimed to reduce the pain and joint inflammation and hence minimize the loss of function. However the potential for serious side effects, such as gastrointestinal bleeding and ulceration, exacerbation of hypertension, and fluid retention; concerns about their renal and cardiovascular safety particularly in older individuals with co-morbidities limit their use. While in severe cases knee arthoplasty is done which is too costly with unusual eventualities. So the need of the hour is that there should be an alternative mode of treatment in order to provide safe, effective and economical treatment with least or no side effects to the patients with knee osteoarthritis. |