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Clinical study to assess effectiveness and safety of ayurvedic products ostikot tablet, rhukot plus cream and rhukot liniment in patients with osteo arthritis of knee

A Single Center Open label, Randomized Controlled Pilot Clinical Study to Assess and Compare the Efficacy and Tolerability of a combination of Ostikot oral tablets (three 1 g tablets twice daily) and Rhukot Plus cream external application v/s Ostikot oral tablets (three 1 g tablets twice daily) and Rhukot Liniment external application v/s Ostikot tablet (three 1 g tablets twice daily) alone in Subjects with Osteo Arthritis of Knee over a period of 12 weeks

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/02/005489
Enrollment
75
Registered
2015-02-02
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: M179- Osteoarthritis of knee, unspecified

Interventions

Intervention1: Ostikot Oral Tablets 1g tablets will be given in a dose of 3 each will be given twice daily over a period of 12 weeks: The tablets are prepared under GMP at vaidyaratnam PS Variers Arya

Sponsors

Clinfound Clinical Research Services PvtLtd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosed with idiopathic KOA according to the clinical guidelines of the American College of Rheumatology. The guidelines include patients currently experiencing pain in one or both knees with at least 3 of the following 6 conditions: 1) aged 50 to 70 years, 2) morning stiffness within 30 minutes of waking, 3) crepitus, 4) bony tenderness, 5) bony enlargement, and 6) no palpable warmth. 2.VAS score during the most painful knee movement between 40-70 mm 3.Lequesneâ??s functional index score between 6-10 points 4.Patients ready to give written informed consent and willing to comply the study protocol

Exclusion criteria

Exclusion criteria: 1.Inflammatory diseases, including rheumatoid arthritis 2.Cancer 3.Traumatic injury that might be related to the current knee pain 4.Autoimmune disease 5.Uncontrolled hypertension 6.Diabetes mellitus requiring insulin injection 7.Life-threatening cardiovascular or neurological events within the past year 8.Pregnant and lactating women 9.Chronic respiratory disease 10.Hemorrhagic disorder 11.Alcohol or drug addiction 12.Active infectious disease, including tuberculosis 13.Significant knee joint deformity 14.Knee replacement surgery for the affected knee 15.Knee arthroscopy within the past 2 years 16.Steroid injection in the knee joints within the past 3 months 17.Viscosupplement injections in the knee joints within the past 6 months 18.Joint fluid injection within the past 6 months 19.Acupuncture, Ayurvedic Therapy, or herbal medicine within the past 4 weeks.

Design outcomes

Primary

MeasureTime frame
The primary outcome with respect to the effectiveness on KOA will be the mean change in the global scale value of the Western Ontario and McMaster Osteoarthritis Index (WOMAC) from baseline to 12 weeks.Timepoint: Baseline week 2 week 4 week 6 week 8 week 10 week 12—

Secondary

MeasureTime frame
1. Change in VAS From Baseline to End of Treatment 2. Change in LFI from Baseline to End of Treatment 3. Changes in ESR From Baseline to End of TreatmentTimepoint: Baseline week 2 week 4 week 6 week 8 week 10 week 12—

Countries

India

Contacts

Public ContactDrSreejith Sreekumar

Clinfound Clinical

drsreejith@clinfound.com0484-606-2400

Outcome results

None listed

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