Evaluating the safety and efficacy of a combination of oral and topical Unani formulations in Waja‘ al-Maf ?s?il (Osteoarthritis Knee)
- Conditions
- Health Condition 1: - Health Condition 2: M170- Bilateral primary osteoarthritis of knee
- Registration Number
- CTRI/2024/07/070640
- Lead Sponsor
- ational Research Institute of Unani Medicine for Skin Disorders
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Reduction in Pain by Using VAS <br/ ><br>2.Reduction in WOMAC Scores from baselineTimepoint: 42 Days
- Secondary Outcome Measures
Name Time Method 1.Joint Tenderness On a 4 Point Likert Scale <br/ ><br>2.50 Foot Walk TestTimepoint: 42 Days