A prospective open labelled single arm non- randomized single centric phase II clinical trial on Komoothira Silasathu Chooranam in the management of Thandagavatham (Lumbar spondylosis)
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The outcome will be aimed at reducing the symptoms of Thandagavatham(Lumbar sponsylosis)and to determine the therapeutic efficacy of clinical trials drug(komoothira silasathu chooranam)
Overview
Brief Summary
This is a A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF KOMOOTHIRA SILASATHU CHOORANAM IN THE MANAGEMENT OFTHANDAGAVATHAM (LUMBAR SPONDYLOSIS).After purification of the trial drug KOMOOTHIRA SILASATHU, chooranam is prepared and administered at the dosage of 130mgs with the adjuvant Elathy kudineer for 48 days,which is given to 40 known lumbar spondylosis patient( 20 OP and 20 IP patients). The primary outcome will be to determine the therapeutic efficacy of KOMOOTHIRA SILASATHU CHOORANAM in the management of Thandagavatham (lumbar spondylosis ).The secondary outcome will be to collect various Siddha literatures on THANDAGAVATHAM, ,to perform physicochemical, phytochemical, bio chemical analysis of KOMOOTHIRA SILASATHU CHOORANAM ,to evaluate safety profile for acute and sub-acute toxicity of KOMOOTHIRA SILASATHU CHOORANAM,to evaluate pharmacological activities of KOMOOTHIRA SILASATHU CHOORANAM,to study about the prevalence of THANDAGAVATHAM in relation with diet and lifestyle,to evaluate Siddha parameters (including Envagaithervu, Neerkuri-Neikuri) changes and dhegi of THANDAGAVATHAM patients during trial period,to evaluate modern parametric changes in THANDAGAVATHAM,to assess the quality of life of THANDAGAVATHAM patients and to document Bio statistical analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Pain and stiffness in the lumbar region 2.Patient presenting with or without radiating pain to lower limb 3.Difficulty in range of motion 4.Patient who are willing to participate in the study.
Exclusion Criteria
- •1.Osteoarthritis of hip 2.Patient undergone spinal surgery 3.TB-Spine 4.SLE 5.Infection 6.Rheumatoid arthritis 7.Fracture of spine 8.Chronic renal and liver disease patients 9.Pregnancy and lactating mother.
Outcomes
Primary Outcomes
The outcome will be aimed at reducing the symptoms of Thandagavatham(Lumbar sponsylosis)and to determine the therapeutic efficacy of clinical trials drug(komoothira silasathu chooranam)
Time Frame: 48 days
Secondary Outcomes
- 1.To collect various aspects of Thandagavatham in Siddha literatures.(2.To evaluate physico chemical,phyto chemical and bio chemical characters of Komoothira Silasathu chooranam.)
Investigators
V SAKTHIPRIYA
Government Siddha Medical College and Hospital, Palayamkottai