To study the effect of Panchakarma Essential (Nirgundi-based formulation) in Knee Osteoarthritis.
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2023/07/055689
- Lead Sponsor
- Mprex Healthcare Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Male and female subjects 30-60 years of age (both inclusive)
2. The patient diagnosed with an OA of the knee for greater than 3 months
3. VAS (visual analog scale) score during the most painful knee movement between 40-70 mm.
4. Subjects with or without consuming analgesics and anti-inflammatory medicines.
5. Willing to refrain from taking ibuprofen, aspirin, other NSAIDs, or any other pain reliever (OTC or prescription) during the entire trial.
6. Ambulatory subject able to provide verbal and written consent and ready to comply with all study procedures.
1. Female subjects, who are pregnant, breastfeeding, or planning to become pregnant.
2. Recent injury in the area affected by OA of the knee (past 4 months)
4. History of underlying inflammatory arthropathy or severe OA (VAS score greater than 70)
5. Have taken any intra-articular treatment/injections with a corticosteroid or hyaluronic acid within 6 months preceding the treatment period.
6. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent
7. Participation in any osteoarthritis related trials involving investigational products within 30 days prior to the screening Visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method