A prospective open labelled single arm non-randomized single centricphase II clinical trial to determine the effectiveness of Rashnadi Chooranam in the management of Kumbavatham(Periarthritis)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The outcome will be aimed at reducing the symptoms of Kumbavatham(Periarthritis)and to determine the therapeutic efficacy of clinical trials drug(Rashnadi chooranam)
Study Overview
Brief Summary
The study is a prospective open labelled single arm non randomized single centric phase II non randomized clinical study to evaluate the therapeutic efficacy of RASHNADI CHOORANAM in the management of KUMBAVATHAM(PERIARTHRITIS).The trial drug will be administered at the dose of 2g twice a day orally after food for 45 days in 40patients.The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital,palayamkottai,Tirunelveli,Tamilnadu.The primary outcome will be to determine the therapeutic efficacy of RASHNADI CHOORANAM in the management of KUMBAVATHAM (PERIARTHRITIS).
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient having main symptoms of shoulder joint pain, numbness ,wasting in the shoulder region and arms, restricted movement of the upper limbs, loss of abduction &forward flexion, stiffness of the shoulder joint.
- •Diabetes mellitus.
Exclusion Criteria
- •Age: below 29 to above 61 years Rheumatoid arthritis Ischaemic heart diseases Pregnancy and lactating mother Recent shoulders dislocation.
- •Recent shoulder fracture.
Outcomes
Primary Outcomes
The outcome will be aimed at reducing the symptoms of Kumbavatham(Periarthritis)and to determine the therapeutic efficacy of clinical trials drug(Rashnadi chooranam)
Time Frame: 45 days
Secondary Outcomes
- Evaluation of additional effects and siddha parameters changes in kumba vatham