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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

Clinical evaluation of the effect on oral administration of PAÃ?CA CŪTA MEḺUKU along with external POṬI TIMIRTAL therapy in management of MÄ?L MŪCCU VÄ?TAM

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020855
Enrollment
40
Registered
2019-08-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G710- Muscular dystrophy

Interventions

Intervention1: pañca cūta meḻuku: Dose: 1mg/kg with sufficient quantity of honey Duration: The drug will be administered for a period of 10 cycles, in which 1 cycle involves bi-dose administration

Sponsors

Geetha Sudheer R
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Children with Heart failure Continuous mechanical ventilation Under continuous usage of other medications Renal insufficiency, retinal disorder, Hypotension or Hypertension

Design outcomes

Primary

MeasureTime frame
Mean change in - 6Minute Walk Test - CPK levels - North Star Ambulatory AssessmentTimepoint: 45 days, 90 days, 135 days, 180 days

Secondary

MeasureTime frame
Cardia and Pulmonary function test Liver and Renal function testsTimepoint: 45 days, 90 days, 135 days and 180 days

Countries

India

Contacts

Public ContactGeetha Sudheer R

Government Siddha Medical College and Hospital

dr.dks.2012@gmail.com9443439049

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026