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.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2010/091/001251
• Date of registration: 19-08-2010
• Prospective Registration: No
• Primary sponsor: Principle investigator
• Public title: 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.
• Scientific title: NRINF02, Glucosamine sulphate, Combination of two, in the treatment of painful osteoarthritis: Randomized,single blind ,placebo controlled trial
• Date of first enrolment: 18-09-2008
• Target sample size: 120
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=2048
• Study type: Interventional
• Study design: Randomized, Parallel Group, Multiple Arm Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant Blinded
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Dr Chanda kulkani
• Affiliation: St Johns Medical College

• Name: Dr Chanda Kulkarni
• Affiliation: St Johns Medical College

Key inclusion & exclusion criteria

Inclusion criteria: » 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: 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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Osteoarthritis

Intervention(s)

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: » Placebo (Microcrystalline cellulose): 400mg;bd;42 days

Rescue medication : paracetamol(upto 2000mg)

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

NIL

Source(s) of Monetary Support

NATURAL REMEDIES PVT. LTD., R&D Centre, Plot No. 5B, Veerasandra Industrial Area, 19th K.M. Stone, Hosur Road, Electronic City Post, Bangalore - 560 100, India

Ethics review

Status: Approved
Approval date: 06/08/2008
Contact:

Institutional Ethical Review Board St Johns Medical College & Hospital