CTRI/2023/07/055689
Not Yet Recruiting
Phase 4
A Clinical Study to Evaluate the Safety and Efficacy of Panchakarma Essential (Nirgundi-based formulation) in reducing symptoms of Knee Osteoarthritis. - NI
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mprex Healthcare Pvt. Ltd.
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Not Yet Recruiting
Phase 2
Effect of Decoction of Cuscuta Reflexa and local application of Saussurea Lappa and Honey in the management of Melasma.CTRI/2021/03/032083Central Council of Research in Unani Medicine New Delhi
Not Yet Recruiting
Phase 4
To study the effect of Panchakarma Essential in male patients with anxiety.CTRI/2023/07/055723Mprex Healthcare Pvt. Ltd.
Not Yet Recruiting
Phase 4
To study the effect of Panchakarma Essential in female patients with anxiety.CTRI/2023/08/056234Mprex Healthcare Pvt. Ltd.
Completed
Phase 2
Green Tea Ginger Flavor for Digestive WellbeingCTRI/2018/02/011860The Himalaya Drug Company40
Not Yet Recruiting
N/A
To study the effect of Panchakarma Essential in reducing symptoms with cardiopulmonarydisordersHealth Condition 1: I249- Acute ischemic heart disease, unspecifiedCTRI/2023/11/060197Mprex Healthcare Pvt.Ltd. Wakad, pune