A clinical trial to study the effect of Ayurveda in patients with duchenne muscular dystrophy

Phase 3

Recruiting

• Conditions: Muscular dystrophy. Ayurveda Condition: MAMSAGATAVATAKOPA,

• Registration Number: CTRI/2022/04/042342
• Lead Sponsor: Dr Rashmi R

Brief Summary

This study is a randomized clinical trial toevaluate the efficacy of Ayurveda interventions as an add-on therapy inpatients with Duchenne Muscular Dystrophy comparing with the conventionaltreatment alone and explore the utility of neurophysiologic investigations inprognostication. This study hypothesized that Ayurveda interventions as anadd-on therapy would improve the clinical, functional, cardiac autonomicfunctions, cortical excitability measures and serum creatinine kinase markersmore than the conventional treatment in Duchenne Muscular Dystrophy. TheAyurveda interventions Sanjivani vati, Ashwagandha choorna, Dhanwantharam taila101 A will be given internally and Ksheerabala taila will be given for abhyanga(external oil application) and matravasti (oil enema in small dose). Theprimary outcome measures are functional measures and ayurveda rating scales.Secondary outcome measures are heart rate variability (HRV), echocardiography, transcranialmagnetic stimulation (TMS), serum creatinine kinase levels and quality of lifeusing PedsQL 3.0 DMD Module. Monthly follow ups will be done for 3 months ofintervention period and one month after treatment. The primary end point willbe at 2 months of intervention period.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-16
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

Genetically confirmed ambulant patients of Duchenne Muscular Dystrophy (DMD) with elevated serum creatinine kinase Clinical signs consistent with DMD like progressive loss of function delayed walking frequent falls difficulty with running and climbing stairs positive Gower sign and calf pseudohypertrophy.

Exclusion Criteria

• Non-ambulant patients with advanced symptoms of cardiomyopathy and respiratory complications Other muscular dystrophies and myopathies like becker muscular dystrophy, congenital muscular dystrophies.
• myelopathies, congenital myopathies and metabolic muscle diseases Evidence of any malignancy With contraindications for TMS like major head injury, epilepsy, metallic implants in head and neck areas Patients under steroid medication for a duration of more than six months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
6-Minute Walk Test (6MWT),	2 months
North Star Ambulatory Assessment (NSAA), Timed function tests - Rise from supine, climb four standard stairs, walk/run 10m	2 months
Functional measures -	2 months
Ayurveda Rating scales -	2 months
Vata Rating scale, dehabala pariksha, agnibala pariksha, chetas bala pariksha	2 months

Secondary Outcome Measures

Name	Time	Method
HRV measures, TMS measures, Echocardiography,Serum Creatinine kinase levels, PedsQL 3.0 DMD Module, Morbidity functional score	2 months

Trial Locations

Locations (1)

National Institute of Mental health and Neurosciences; 🇮🇳 Bangalore, KARNATAKA, India

National Institute of Mental health and Neurosciences

🇮🇳Bangalore, KARNATAKA, India

Rashmi R

Principal investigator

9961704592

dr.rashmi.ayu@gmail.com