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

Phase 3
Conditions
Health Condition 1: null- UTHIRA VAATHA SURONITHAM (Rheumatoid arthritis)
Registration Number
CTRI/2014/11/005180
Lead Sponsor
AYOTHIDOSS PANDITHAR HOSPITA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
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 â?? 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
NameTimeMethod
It is mainly assessed by UNIVERSAL PAIN ASSESSMENT SCALE- Numeric Rating Scale before and after treatment. <br/ ><br> <br/ ><br>UNIVERSAL PAIN ASSESMENT SCALE: <br/ ><br> Grade 0 : No Pain <br/ ><br> Grade 1 -3 : Mild pain <br/ ><br> Grade 4-6 : Moderate pain <br/ ><br> Grade 7-10: Severe pain <br/ ><br>Timepoint: PRE STUDY SCREENING AND AFTER TREATMENT
Secondary Outcome Measures
NameTimeMethod
It is assessed by the following parameters before and after treatment. <br/ ><br>1.Reduction in clinical symptoms <br/ ><br>2.Health Assessment Questionnarie [20] <br/ ><br>3.Hb and ESR variations. <br/ ><br>4.RA and CRP variations <br/ ><br>Timepoint: PRE STUDY SCREENING AND AFTER TREATMENT
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