Phase II Non Randomized Clinical Study In The Management Of Sirakambavatham (Cerebral Palsy) With The Validation Of Siddha Trial Drug Sirakambavathathirkku Kudineer As Internal Medicine And Saranai Thailam As External Therapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- It is mainly assessed by reduction in clinical symptoms
Study Overview
Brief Summary
This is a single Non-Randomized Open Clinical Trial to study the safety and efficacy of siddha trial drug Sirakambavathathirkku Kudineer (internal medicine) is to be given about 5-10 ml twice a day for 60 days and External therapy of Saranai Thailam (thokkanam) on the affected area for 60 days.Clinical Trail conducted after conducting Pre clinical study. The trial drug Sirakambavathathirkku kudineer is mentioned in Agathiyar Vaithiya Sinthamani and External therapy saranai thailam (Thokkanam) is mentioned in Agathiyar Vaithiya Pooranam 205.During the study related data will be recorded and documented .After the completion of the trial all the data will be statistically analyzed.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Delay in gross motor and fine motor milestones Delay in intellectual and cognitive functional development Abnormal muscle tone and reflexes spastic cerebral palsy.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
It is mainly assessed by reduction in clinical symptoms
Time Frame: 60 days
Secondary Outcomes
- It is assessed by comparing the sensory functions connecting parameters and fine motor functions of the upper limb(60 days)
Investigators
Dr M Kamali
Government Siddha Medical College Arumbakkam Chennai 106