A clinical study to see the effect of some Ayurvedic formulations in the management of Arthritis knee.

Phase 2

Completed

• Conditions: osteoarthritis knee

• Registration Number: CTRI/2014/02/004388
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

Thisis an open label interventional study for evaluating the safety and efficacy ofclassical Ayurvedic therapeutic regimen consisting of Vatari guggulu 500 mg 2tablets thrice a day, Maharasnadi kwatha 20 ml twice a day, local applicationof Narayan taila for 12 weeks in 180 patients with Osteoarthritis knee. Thetrial will be conducted in three centers. In this proposed study theeffect  of this combination will beevaluated for clinical response and change in the quality of life by usingstandard parameters. The primary outcome measures will be change in WOMAC totalscore. The secondary outcomes will be change in WOMAC stiffness domain score, changein WOMAC physical function Domain, global assessment of disease activity, changein the visual analogue scale(VAS) for pain in last 48 hrs. and Ayurvedicdisease specific symptoms at the end of 14th day,28thday,42nd day,56th day, 70th day and 84thday and after 4 weeks of follow-up without the trial regimen.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-29
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 1.Patient with Primary Osteoarthritis (knee) fulfilling the diagnostic criteria of osteoarthritis recommended by the American College of Rheumatology.
• Pain in the affected joint(s) > 3 months (with radiological changes as per Grade I to III of Kellgren & Lawrence Radiological scale).
• Willing and able to participate in the study for 16 weeks.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in WOMAC total score	at baseline,at 84th day and at the end of follow up after 16 weeks.

Secondary Outcome Measures

Name	Time	Method
1.Change in WOMAC stiffness Domain Score	2.Change in WOMAC Physical function Domain

Trial Locations

Locations (3)

Dr Achanta Lakshmipati Research Centre for Ayurveda (ALRCA) & Hospital; 🇮🇳 Chennai, TAMIL NADU, India

National Ayurveda Dietetics Research Institute & Hospital; 🇮🇳 Bangalore, KARNATAKA, India

National Research Institute for Ayurveda-siddha Human Resource Development & Hospital, Gwalior; 🇮🇳 Gwalior, MADHYA PRADESH, India

Dr Achanta Lakshmipati Research Centre for Ayurveda (ALRCA) & Hospital

🇮🇳Chennai, TAMIL NADU, India

Dr pramila devi

Principal investigator

044-22541536

alrca.chennai@gmail.com