clinical research on siddha medicine Gendhaga Vallaathi in the treatment of Uthira Vaatha Suronitham(Rheumatoid Arthritis)

Phase 3

Recruiting

• Conditions: UTHIRA VAATHA SURONITHAM (Rheumatoid arthritis)

• Registration Number: CTRI/2014/11/005180
• Lead Sponsor: AYOTHIDOSS PANDITHAR HOSPITAL

Brief Summary

It is a single, non-randomized, open-label trial to determine the efficacy and safety of GENDHAGA VALLAATHI (Prepared from herbo mineral constitutents) in patients with Uthira vaatha suronitham (Rheumatoid arthritis). In this trial 40 patients will be recruited and the trial drug will be administered 6 gms twice a day for a period of 48 days. During this trial period all the study related data will be recorded and documented in a page separate trial master file for each patients.During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in NIS OPD/IPD.The entire trial will be monitored by the research monitoring committee OF NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically .The out come of this trial will be published in Indian Journal of Medical Research.xml:namespace prefix = o /

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-15
• Last Update Posted: 2014-10-17

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1. Guidelines for classification : a.
• 4 of 7 criteria are required to classify a patient as having RA b.
• Patients with 2 or more clinical diagnosis are not excluded 3) Criteria : Morning stiffness: stiffness in and around the joints lasting 1 hr before maximal improvement.
• 2. Arthritis of 3 or more joint areas: Atleast 3 joints areas , have soft tissue swellings or joint effusions not just bony overgrowth.The 14 possible joints areas involved are right or left proximal interphalangeal joint,metacarpophalangealjoint,wrist,elbow,knee,ankle, metatarsophalangeal joint 3) Symmetrical arthritis 4) Arthritis of hand joints-these should be atleast 6 weeks 5) Rheumatoid factor positive 6) Rheumatoid nodules [21] 7) Anti – CCP positive 8) Patients who had the pain score of 0 to 6.
• 9. Patients willing for admission and stay in IPD or willing to attend OPD 10)Patient willing to undergo Radiological investigation and provide blood and urine for laboratory investigation.
• 11. Patient willing to sign the informed consent stating that he/she will consciously stick to the treatment during 48 days but can opt out of the trial of his/her own conscious discretion.

Exclusion Criteria

•Diabetes Mellitus •Hypertension •Pregnancy and lactation •Any other serious systemic illness •Drug Addicts •SLE •H/O undergone DMARDs (past 3 month) •Patients who had the pain score of 7 to 10 •Osteoarthritis •Tubercular Arthritis •Gouty Arthritis •Psoriatic Arthritis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
It is mainly assessed by UNIVERSAL PAIN ASSESSMENT SCALE- Numeric Rating Scale before and after treatment.	PRE STUDY SCREENING AND AFTER TREATMENT
UNIVERSAL PAIN ASSESMENT SCALE:	PRE STUDY SCREENING AND AFTER TREATMENT
Grade 0 : No Pain	PRE STUDY SCREENING AND AFTER TREATMENT
Grade 1 -3 : Mild pain	PRE STUDY SCREENING AND AFTER TREATMENT
Grade 4-6 : Moderate pain	PRE STUDY SCREENING AND AFTER TREATMENT
Grade 7-10: Severe pain	PRE STUDY SCREENING AND AFTER TREATMENT

Secondary Outcome Measures

Name	Time	Method
It is assessed by the following parameters before and after treatment.	1.Reduction in clinical symptoms

Trial Locations

Locations (1)

Ayothidoss pandithar Hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

Ayothidoss pandithar Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

DrARajalakshmi

Principal investigator

9487236968

rajibsms@gmail.com