A clinical study on Meganathi kuligai for UthiraVatha suronitham(Rheumatoid Arthritis)

Phase 2

Not yet recruiting

• Conditions: Rheumatoid arthritis with rheumatoid factor, unspecified,

• Registration Number: CTRI/2020/03/024153
• Lead Sponsor: Government siddha medical college and hospital

Brief Summary

The study is a prospective open labelled phase II Non-Randomized clinical study to evaluate the therapeutic efficacy of Meganathi Kuligai in the management of Uthiravatha Suronitham ( Rheumatoid Arthritis). The trial drug will be administered at the dose of 1/2-1 Kundri Edai (60-130mg)/kgBW/ Twice a day(orally) with Honey as adjuvant for 45 days in 40 patients. The trial period of 12 months will be carrying out in Government siddha medical college and hospital, Palayamkottai, Tirunelveli, Tamil Nadu 627 002. The primary out come will be the evaluation of therapeutic efficacy of trial drug Meganathi Kuligai. The secondary outcome will be the evaluation of siddha diagnostic parameters, assessment of safety profile of trial drug , assessment of pharmacological and Bio chemical parameters of trial drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-04
• Last Update Posted: 2020-03-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Symmetrical joint involvement 2.Involvement of 3 or more joints 3.Florid morning stiffness and swelling that lasts for few hours or days 4.pain,joint swelling especially in the interphalangeal joints 5.pain criteria score should be greater than or equal to 6.

Exclusion Criteria

1.Psoriatic arthritis 2.Gout 3.Mixed connective tissue disorders 4.SLE.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Reducing the pain, swelling, early morning stiffness,deformities.	6 weeks
2.To assess improvement based on the disease activity pain score.	6 weeks

Secondary Outcome Measures

Name	Time	Method
1.Evaluation of addition effects and siddha parameters during trial period.	2. Determination of safety profile of trial drug .

Trial Locations

Locations (1)

Government siddha medical college; 🇮🇳 Tirunelveli, TAMIL NADU, India

Government siddha medical college

🇮🇳Tirunelveli, TAMIL NADU, India

R Sathiya

Principal investigator

9884132729

Anbuthozher@gmail.com