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

Completed

• Conditions: Osteoarthritis of knee, unspecified,

• Registration Number: CTRI/2015/02/005489
• Lead Sponsor: Clinfound Clinical Research Services PvtLtd

Brief Summary

Thisis a randomized pilot, open labelled, prospective, single-center study toevaluate and compare the efficacy and safety of a combination of Ostikot oraltablets (three 1 g tablets twice daily) and Rhukot Plus cream v/s Ostikot oraltablets (three 1 g tablets twice daily) and Rhukot Liniment v/s Ostikot tablet alone(three 1 g tablets twice daily) in Subjects with Osteo Arthritis of Knee. All medicines used as Ayurvedic formulations prepared by Vaidyaratnam PS Varier’s Aryavaidyasala, Kottakkal. Ostikot tablets contain Alpinia galanga,Cassia fistula,Zingiber officinale,Tribulusterrestris,Ricinus communis,Boerhaavia diffusa and Commiphora mukul. Rhukot plus cream contains Azadirachta indica,Cedrus deodara,Menthaspecieses,Cinnamomum camphora and Gaultheria fragrantissima, Rhukot liniment contains Cedrus deodara,Azadirachtaindica,Camphora officinaram,Gaultheria fragrantissima and Mentha specieses. The clinical study is for a duration of 12 weeks for each subject and will recruit a total of 75 subject (25 in each group

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-10
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 75

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.Lequesne’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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	Baseline week 2 week 4 week 6 week 8 week 10 week 12

Secondary Outcome Measures

Name	Time	Method
1.Change in VAS From Baseline to End of Treatment	2.Change in LFI from Baseline to End of Treatment

Trial Locations

Locations (1)

Vaidyaratnam P. S. Variers Arya Vaidya Sala, Kottakkal Charitable Hospital; 🇮🇳 Malappuram, KERALA, India

Vaidyaratnam P. S. Variers Arya Vaidya Sala, Kottakkal Charitable Hospital

🇮🇳Malappuram, KERALA, India

Dr PraveenM

Principal investigator

04832806603

varier.praveen@gmail.com