An open clinical trail on "MERUGULLI THYLAM"(Internal medicine) in the treatment of Mudakkuvatham.
- Conditions
- Arthritis involving three or more joints,Symmetrical joint involvement Morning stiffness swelling of small joints of hand and foot
- Registration Number
- CTRI/2018/03/012365
- Lead Sponsor
- National Institute of Siddha
- Brief Summary
Its is a single non randomized open label trial to determine the efficacy and safety of "MERUGULLI THYLAM"(Herbal formulation) in the patients with VALI AZHAL KEELVAYU(Rheumatoid arthritis) in this trial 40 patients will be recruited and the trial drug will be administered kaal balam-9gram(9 ml)-3 days morning only(2 days drug holiday) for a period of 45 days, During the trail period if any AE/SAF/SUSAR will be noticed and referred to pharmacovigilance department in NIS and further management will also be given in NIS OPD/IPD. The entire trail will be monitored by the research monitoring committee of NIS. During this trail all the safety efficacy parameters will be recorded in the CRF after completion of the trail all the safety related data will be analysed statistically, the outcome of this trail will be published in Indian Journal of Medical Research.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 40
Age:20-60 years Sex:Both male and female Symmetrical joint involvement Arthritis of three or more joints Rheumatoid factor positive or negative Morning stiffness Deformities like Swan neck deformity and Button hole deformity Swelling especially in the inter-phalangeal joint Patients willing for admission in IPD or willing to attend OPD Patient willing to undergo Radiological investigation and for laboratory investigation Patients willing to sign the informed consent stating that he/she will consciously stick to the treatment during 45 days but can opt out of the trial of his/her own conscious discretion.
Pregnancy and lactation Tubercular arthritis Any other serious systemic illness like cancer, cardiac disease Osteoarthritis Psoriatic arthritis Gouty arthritis Diabetic mellitus Hypertension Thyroidism(Hypo/hyper).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of pain is by Universal pain assessment scale.Other clinical signs and symptoms will be assessed by Gradation methods before and After treatment (45 days) Assessment of pain is by Universal pain assessment scale.Other clinical signs and symptoms will be assessed by Gradation methods
- Secondary Outcome Measures
Name Time Method Laboratory investigations such as RA factor,CRP,ASO titre will also be done at the end of the study Before and after treatment(45 days)
Trial Locations
- Locations (1)
Ayothidoss pandithar hospital
🇮🇳Kancheepuram, TAMIL NADU, India
Ayothidoss pandithar hospital🇮🇳Kancheepuram, TAMIL NADU, IndiaDR M SuganthiPrincipal investigator8056786753drsuganthi6@yahoo.com