A clinical trial to assess the efficacy of poly-herbal formulation "NARTANA" in comparison with Diclofenac in patients with mild to moderate oseroarthritis of knees.

Phase 3

Completed

• Conditions: Osteoarthritis

• Registration Number: CTRI/2010/091/000365
• Lead Sponsor: Nisarga Biotech PvtLtd

Brief Summary

A Phase III, double blind, randomised, controlled clinical study is undertaken to evaluate the efficacy & safety of poly-herbal formulation "NARTANA" in 80 patients with mild to moderate oesteoarthritis of knees. The trial shall be conducted at two centres:1)Deenanath Mangeshkar Hospital & Research Centre, Pune & 2)Yogesh Hospital, Pune. The treatment will be given for 3 months. Diclofenac is used as a comparator (active controlled)drug. Efficacy of the drug will be evaluated based on visits on day (-7), 1, 15, 30, 45, 60, 75 & 90.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-14
• Study Completion: 2012-06-09
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1)Age above 40 years of either sex.
• 2)Diagnosis of OA in at least one knee joint (ACR classification for knee OA) confirmed by X ray.
• 3)Subject willing to come for regular follow up visits 4)Subject ready to give written informed consent.

Exclusion Criteria

• 1)Patients who have very severe or doubtful OA diagnosis.
• 2)Subjects with severe co-morbidities, other known rheumatic conditions, congestive heart failure, Ischemic Heart Disease(IHD) and severe and or uncontrolled Hypertension3)The patients with current or recent corticosteroid treatment; or ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicines or concurrent pain relieving medication such as antipyretics, analgesics, tranquilizers, hypnoties, excessive alcohol, NSAIDSs.4)Patients incapacitated or bound to wheel chair or bed and unable to carry out self care activities.5)History of active peptic ulcer, severe renal, hepatic or hemopoietic disease or severe cardiac insufficiency or undergoing artery bypass graft (CABG) surgery.6)Non degenerative joint diseases or other joint.7)Patient with history of known hypersensitivity to Diclofenac.8)Any condition that, in the opinion of the Investigator,does not justify the patient?s inclusion in the study.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of poly-herbal formulation "Nartana" in comparison with Diclofenac	at visit on day 1,45 & 90

Secondary Outcome Measures

Name	Time	Method
Safety- Adverse events, serious adverse events, during the subject participation period of 90 days.	at visit on day 1,45 & 90

Trial Locations

Locations (2)

Deenanath Mangeshkar Hospital & Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

Yogesh Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Deenanath Mangeshkar Hospital & Research Centre

🇮🇳Pune, MAHARASHTRA, India

Dr Milind Modak

Principal investigator

02040151000

research@dmhospital.org