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.

A Phase III, double blind, randomised, parallel design, controlled clinical study to evaluate the efficacy and safety of poly-herbal formulation "NARTANA" in patients with mild to moderate osteoarthritis of knees.

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

CTRI

Registry ID

CTRI/2010/091/000365

Enrollment

Registered

2010-04-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Osteoarthritis

Interventions

Intervention1: NARTANA: 450mg capsule bid for first 15 days and 450mg od for 75 days Control Intervention1: DICLOFENAC: 50mg tab bid for first 15 days and 100 mg tab.od for next 75 days

Eligibility

Inclusion criteria

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

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 Hypertension 3) 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.

Design outcomes

Primary

Measure	Time frame
Efficacy of poly-herbal formulation "Nartana" in comparison with DiclofenacTimepoint: at visit on day 1,45 & 90	—

Secondary

Measure	Time frame
Safety- Adverse events, serious adverse events, during the subject participation period of 90 days.Timepoint: at visit on day 1,45 & 90	—

Countries

India

Contacts

Public ContactDr Milind Modak

drmilindmodak@gmail.com02024478740

Outcome results

None listed

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