A clinical study on Kodiveli chooranam for Vali Azhal Keel Vayu(Rheumatoid Arthritis)

Phase 2

Not yet recruiting

• Conditions: Rheumatoid arthritis with rheumatoid factor, unspecified,

• Registration Number: CTRI/2019/05/019031
• Lead Sponsor: Govt 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  KODIVELI CHOORANAM  in the management of  vali azhal keel vayu (Rheumatoid arthritis).The trial drug will be administered at the dose of 20mg/kg/Body weight BD before food along with water 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 TamilNadu. The Primary out come will be the evaluation of therapeutic efficacy of trial drug KODIVELI CHOORANAM . The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of  safety profile of trial drug,assessment of  pharmacological and biochemical parameters of trial drug

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-13
• Last Update Posted: 2019-08-05

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 5.Extra pulmonary tuberculosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Reducing the pain, swelling, early morning stiffness, deformities.	45days
2.To assess improvement based on the disease activity pain score.	45days

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)

Govt Siddha Medical College and Hospital; 🇮🇳 Tirunelveli, TAMIL NADU, India

Govt Siddha Medical College and Hospital

🇮🇳Tirunelveli, TAMIL NADU, India

R Srikajan

Principal investigator

9384121796

srikajan1978@gmail.com