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Evaluating the safety and efficacy of a combination of oral and topical Unani formulations in Waja‘ al-Maf ?s?il (Osteoarthritis Knee)

A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of a combination of oral and topical Unani Formulations in the Management of Waja‘ al-Maf ?s?il (Osteoarthritis Knee) - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070640
Enrollment
60
Registered
2024-07-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: - Health Condition 2: M170- Bilateral primary osteoarthritis of knee

Interventions

Intervention1: 1.Safuf(powder)-oral 2.Roghan Gul e Aak-Topical: 1.Safuf(powder) Dosage Form :Safuf(Powder) Dosage:3.5gms BD after meal with water Mode of Administration: oral Composition Of Safuf:Sibr

Sponsors

National Research Institute of Unani Medicine for Skin Disorders
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients of any sex aged between 40to 65years 2.Clinical and Radiographic Knee Osteoarthritis as per the following American College of Rheumatology (ACR) criteria: a. Knee Pain b. Osteophytes on Knee Radiograph, and c. At least 1 of the following 3 criteria: i. Age =40 years ii. Morning Stiffness lasting =30 minutes iii. Crepitus on Active Knee Motion 3.Knee OA of Kellgren-Lawrence Grade 1 to 3 4.Participants who are able and willing to comply with the protocol and to sign IEC approved ICF

Exclusion criteria

Exclusion criteria: 1.Knee OA of Kellgren-Lawrence grade IV 2. Secondary OA, Inflammatory joint diseases (e.g. RA, psoriatic arthritis, gout), or any other type of arthritis 3.Patients on long-term steroid treatment 4.H/o having received intra-articular knee injection (corticosteroids or hyaluronan), or any investigational drug in the previous one month 5.Pregnant or Lactating Women 6.Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction 7.Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies

Design outcomes

Primary

MeasureTime frame
1.Reduction in Pain by Using VAS 2.Reduction in WOMAC Scores from baselineTimepoint: 42 Days

Secondary

MeasureTime frame
1.Joint Tenderness On a 4 Point Likert Scale 2.50 Foot Walk TestTimepoint: 42 Days

Countries

India

Contacts

Public ContactAtiya Begum

National Research Institute of Unani Medicine for Skin Disorders

aarzu763@gmail.com9032519286

Outcome results

None listed

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