Antibiotic-probiotic therapy in early Rheumatoid Arthritis
Phase 2
- Conditions
- Health Condition 1: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvementHealth Condition 2: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement
- Registration Number
- CTRI/2023/06/053478
- Lead Sponsor
- Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Age 18yrs or more on the day of registration
2. Subjects diagnosed to be patient of Rheumatoid Arthritis according to 2010 ACOG-EULAR classification criteria who are treatment naive
3. Subjects willing to give signed informed consent
4. Subjects not on any anti-rheumatic treatment or DMARDs other than occasional NSAIDs
Exclusion Criteria
1. Subjects who have received treatment for RA anytime or antibiotics in the last 6 weeks
2. Subjects with other inflammatory diseases which may act as confounders
3. Any significant co-existing/incapacitating chronic illness
4. Subjects on corticosteroids or any other immunosuppressive therapy
5. Subjects who are pregnant or reproductive couples who have intention of pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in DAS 28 CRP at 6 and 12 weeksTimepoint: 6 and 12 weeks
- Secondary Outcome Measures
Name Time Method Any untoward effect or hypersensitivity reactionTimepoint: At 1 and 2 week