Clinical evaluation of the effect on oral administration of a classical Siddha drug PA�CA CŪTA MEḺUKU along with an external therapy POṬI TIMIRTAL in management of children affected by Myopathy
Phase 2
Completed
- Conditions
- Health Condition 1: G710- Muscular dystrophy
- Registration Number
- CTRI/2019/08/020855
- Lead Sponsor
- Geetha Sudheer R
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
Inclusion Criteria
Subject should be positive for at least two of the criteria given below
1. Elevated CPK levels
2. Genetic testing: Pathogenic deletion, duplication or point mutation of muscular dystrophy related genes
3. Gait abnormality: waddling, wide-based gait with hyperlordosis of the lumbar spine and toe walking
4. Positive Gowerâ??s sign
5. Phenotypic evidence of muscular dystrophy
Willing for functional assessment and ability to comply with scheduled visits, and study restrictions.
Exclusion Criteria
Children with
Heart failure
Continuous mechanical ventilation
Under continuous usage of other medications
Renal insufficiency, retinal disorder,
Hypotension or Hypertension
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in <br/ ><br> - 6Minute Walk Test <br/ ><br> - CPK levels <br/ ><br> - North Star Ambulatory AssessmentTimepoint: 45 days, 90 days, 135 days, 180 days
- Secondary Outcome Measures
Name Time Method Cardia and Pulmonary function test <br/ ><br>Liver and Renal function testsTimepoint: 45 days, 90 days, 135 days and 180 days