A clinical trial to evaluate the safety and efficacy of NRINF02 (Turmeric/haldi) Glucosamine sulphate and combination of these two in the treatment of painful knee osteoarthritis.

NRINF02, Glucosamine sulphate, Combination of two, in the treatment of painful osteoarthritis: Randomized,single blind ,placebo controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001251

Enrollment

120

Registered

2010-08-19

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: NRINF02 (curcuma longa linn.): NRINF02 (500mg/bd/42 days) Intervention2: Glucosamine sulphate: 1500mg

42days

bd Intervention3: Glucosamine sulphate and NR INF02: Glucosamine sulphate 750 mg with NR INF02 500 mg PO twice a day for 42 days Control Intervention1: &raquo

Placebo (Microcrystalline cellulose): 400mg

42 days Rescue medication : paracetamol(upto 2000mg)

Eligibility

Inclusion criteria

Inclusion criteria: Â» Patients at least 40 years of age and with clinical evidence [Knee pain for at least six months and on majority of days during the preceding months and radiological evidence (tibio-femoral osteophytes of at least 1mm Kellgren and Lawrence grade 2 or 3] of OA i.e. Grade 2: definite osteophytes, definite narrowing of joint space and Grade 3: moderate multiple osteophytes, definite narrowing of joints space, some sclerosis and possible deformity of bone contour.

Exclusion criteria

Exclusion criteria: Concurrent medical or arthritic conditions confounding evaluation of the knee OA. Primary predominant patella-femoral disease. History of clinically significant trauma/surgery to the affected knee. Co-existing disease that could preclude the successful completion of trial.

Design outcomes

Primary

Measure	Time frame
Change in the severity of symptoms Patients were assessed on day 0, 21st and 42nd for intensity of OA symptoms by a) Visual analog scale (VAS) (0 to 100) b) WOMAC scale c) Clinician Global Impression of change (CGIC) d) Clinical examination by orthopaedician Safety evaluation: Reported to the investigators in the event of any adverse events which the patient or the investigator may attribute to the test substance treatment during start of treatment and follow up on day 21st and 42nd.Timepoint: 0,21,42 days	—

Measure

Time frame

Change in the severity of symptoms Patients were assessed on day 0, 21st and 42nd for intensity of OA symptoms by a) Visual analog scale (VAS) (0 to 100) b) WOMAC scale c) Clinician Global Impression of change (CGIC) d) Clinical examination by orthopaedician Safety evaluation: Reported to the investigators in the event of any adverse events which the patient or the investigator may attribute to the test substance treatment during start of treatment and follow up on day 21st and 42nd.Timepoint: 0,21,42 days

—

Secondary

Measure	Time frame
Use of rescue medication acetaminophen (paracetamol) was permitted as tablets not exceeding 2000 to 4000 mg/day. The number of tablets used were recorded at each clinic visit and total number was calculated under various treatment arms.Timepoint: 21st and 42nd day	—

Countries

India

Contacts

Public ContactDr Chanda kulkani

St Johns Medical College

drchandakulkarni@gmail.com919886116151

Outcome results

None listed

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