| CTRI Number |
CTRI/2022/04/042342 [Registered on: 29/04/2022] Trial Registered Prospectively |
| Last Modified On: |
06/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Ayurveda in patients with duchenne muscular dystrophy |
|
Scientific Title of Study
|
“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)†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rashmi R |
| Designation |
Ph.D. Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences NIMHANS |
| Address |
Department of Neurophysiology NIMHANS
Hosur Road
Bengaluru
Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
9961704592 |
| Fax |
|
| Email |
dr.rashmi.ayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rashmi R |
| Designation |
Ph.D. Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences NIMHANS |
| Address |
Department of Neurophysiology NIMHANS
Hosur Road
Bengaluru
Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
9961704592 |
| Fax |
|
| Email |
dr.rashmi.ayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaviraja Udupa |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences NIMHANS |
| Address |
Department of Neurophysiology NIMHANS
Hosur Road
Bengaluru
Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
9731452111 |
| Fax |
|
| Email |
kaviudupa@gmail.com |
|
|
Source of Monetary or Material Support
|
| CCRAS (Central Council for Research in Ayurvedic Sciences) under Ministry of AYUSH |
|
|
Primary Sponsor
|
| Name |
Dr Rashmi R |
| Address |
Ph.D. Scholar, Department of Neurophysiology, NIMHANS, Bengaluru – 560029 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Kaviraja Udupa |
Additional Professor, Department of Neurophysiology, NIMHANS, Bengaluru – 560029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rashmi R |
National Institute of Mental health and Neurosciences |
Neurology OPD, First floor,
NIMHANS OPD block
Hosur Road
Bengaluru - 560029
Bangalore
KARNATAKA |
9961704592
dr.rashmi.ayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics sub-committee (Basic Sciences & Neurosciences Div.), NIMHANS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G710||Muscular dystrophy. Ayurveda Condition: MAMSAGATAVATAKOPA, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Prednisolone | Dose - 0.75mg/kg/day
Frequency - Once a day
Oral route of administration
3 months | | 2 | Intervention Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग | (Procedure Reference: Ashtanga hrudaya sutra sthana 2/8, Procedure details: The whole body of the patient is anointed with the medicated oil for 30 min in seven positions with gentle massage with moderate pressure. The massage is done unidirectionally. Then Bashpa swedana (steam therapy) for 15 min will be done)
(1) Medicine Name: Ksheerabala taila, Reference: The Ayurvedic Formulary of India (AFI), Part 1, Volume 1, Page no: 378, 8:11, Route: Topical, Dosage Form: Taila, Dose: 75(ml), Frequency: od, Duration: 10 Days | | 3 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Ashtanga hrudaya sutra sthana 19/12, Procedure details: The patient is made to lie on his left side with right leg flexed. The anal sphincter area is lubricated with the medicated oil. 30 ml of Ksheerabala taila is administered via rectum by gently inserting the enema nozzle into the anal canal. The patient has to lie down for sometime in the same position. The patient has to take light meals before the procedure. The procedure takes 15-20 minutes per day. )
(1) Medicine Name: Ksheerabala taila , Reference: The Ayurvedic Formulary of India (AFI), Part 1, Volume 1, Page no: 378, 8:11 , Route: Rectal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 10 Days | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sanjivani vati, Reference: The Ayurvedic Formulary of India (AFI), Part I. Vol 1, page no. 549, 12:35, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 30(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Ginger juice), Additional Information: -(2) Medicine Name: Dhanwantharam taila 101 A, Reference: The Ayurvedic Formulary of India (AFI), Part 1, Volume 1, Page no: 394, 8:22, Route: Oral, Dosage Form: Taila, Dose: 4(drops), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Lukewarm milk), Additional Information: -(3) Medicine Name: Ashwagandha choorna , Reference: The Ayurvedic Pharmacoepia of India (API), Part1, Volume 1, Page no. 20, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Lukewarm milk), Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Male |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
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 |
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional measures -
6-Minute Walk Test (6MWT),
North Star Ambulatory Assessment (NSAA), Timed function tests - Rise from supine, climb four standard stairs, walk/run 10m
Ayurveda Rating scales -
Vata Rating scale, dehabala pariksha, agnibala pariksha, chetas bala pariksha
|
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HRV measures, TMS measures, Echocardiography, Serum Creatinine kinase levels, PedsQL 3.0 DMD Module, Morbidity functional score |
2 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/05/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized clinical trial to
evaluate the efficacy of Ayurveda interventions as an add-on therapy in
patients with Duchenne Muscular Dystrophy comparing with the conventional
treatment alone and explore the utility of neurophysiologic investigations in
prognostication. This study hypothesized that Ayurveda interventions as an
add-on therapy would improve the clinical, functional, cardiac autonomic
functions, cortical excitability measures and serum creatinine kinase markers
more than the conventional treatment in Duchenne Muscular Dystrophy. The
Ayurveda interventions Sanjivani vati, Ashwagandha choorna, Dhanwantharam taila
101 A will be given internally and Ksheerabala taila will be given for abhyanga
(external oil application) and matravasti (oil enema in small dose). The
primary outcome measures are functional measures and ayurveda rating scales.
Secondary outcome measures are heart rate variability (HRV), echocardiography, transcranial
magnetic stimulation (TMS), serum creatinine kinase levels and quality of life
using PedsQL 3.0 DMD Module. Monthly follow ups will be done for 3 months of
intervention period and one month after treatment. The primary end point will
be at 2 months of intervention period. |