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临床试验/CTRI/2022/04/042342
CTRI/2022/04/042342招募中3 期

“A Randomized clinical trial to evaluate the efficacy of Ayurveda Interventions as an add on therapy on functional, cardiac autonomic and cortical excitability measures in ambulant patients with Duchenne Muscular Dystrophy (Mamsa medagata vata)â€

Dr Rashmi R1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年5月16日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
66
试验地点
1
主要终点
6-Minute Walk Test (6MWT),

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Outcome Assessor Blinded

入排标准

年龄范围
5.00 Year(s) 至 10.00 Year(s)(—)
性别
Male

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

6-Minute Walk Test (6MWT),

时间窗: 2 months

North Star Ambulatory Assessment (NSAA), Timed function tests - Rise from supine, climb four standard stairs, walk/run 10m

时间窗: 2 months

Functional measures -

时间窗: 2 months

Ayurveda Rating scales -

时间窗: 2 months

Vata Rating scale, dehabala pariksha, agnibala pariksha, chetas bala pariksha

时间窗: 2 months

次要结局

  • HRV measures, TMS measures, Echocardiography,Serum Creatinine kinase levels, PedsQL 3.0 DMD Module, Morbidity functional score(2 months)

研究者

发起方
Dr Rashmi R
申办方类型
Other [self]

研究点 (1)

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