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Clinical trial to study the effectiveness of a unani formation, Habb-e-Mafasil, in Primary Knee Osteoarthritis.

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. - NIL

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062496
Enrollment
78
Registered
2024-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M170- Bilateral primary osteoarthritis of knee

Interventions

Intervention1: 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),Ae

Sponsors

Central Council for Research In Unani Medicine New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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. TendernessTimepoint: At day 0, 14 and 28

Secondary

MeasureTime frame
X Ray bilateral knee joints AP and LateralTimepoint: day 0 and 28

Countries

India

Contacts

Public ContactAndleeb Razaq

Regional Research Institute Of Unani Medicine (RRIUM) Srinagar

hussainzaffar6@gmail.com7006021996

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026