| CTRI Number |
CTRI/2025/10/095902 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Small Study on How Kushmand Rasayana and Panchkarma Therapies May Help Boys with Duchenne Muscular Dystrophy (DMD) Who Can Still Walk |
|
Scientific Title of Study
|
Efficacy of Kushmand Rasayana and Panchkarma therapies in managing ambulatory boys with Duchenne’s Muscular Dystrophy (DMD)- A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harshit Jain |
| Designation |
POST GRADUATE SCHOLAR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Room No.-406, 4th floor, Department of Kaumarabhritya, Academic Block
Gautampuri, Sarita Vihar, New Delhi-110076
South
DELHI
110076
India |
| Phone |
09953134395 |
| Fax |
|
| Email |
harshjain2198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MAHAPATRA ARUN KUMAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Room No.-409, 4th floor, Department of Kaumarabhritya, Academic Block
Gautampuri, Sarita Vihar, New Delhi-110076
South
DELHI
110076
India |
| Phone |
8506821974 |
| Fax |
|
| Email |
ayuarun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshit Jain |
| Designation |
POST GRADUATE SCHOLAR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Room No.-406, 4th floor, Department of Kaumarabhritya, Academic Block
Gautampuri, Sarita Vihar, New Delhi-110076
South
DELHI
110076
India |
| Phone |
09953134395 |
| Fax |
|
| Email |
harshjain2198@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF AYURVEDA |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Gautampuri, Sarita Vihar, New Delhi-110076 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harshit Jain |
ALL INDIA INSTITUTE OF AYURVEDA |
OPD No.-208, Kaumarabhrritya OPD, 2nd floor, Hospital Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, Delhi-110076
South
DELHI |
9953134395
harshjain2198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M625||Muscle wasting and atrophy, not elsewhere classified. Ayurveda Condition: MAMSAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chitrakadi Vati, Reference: Bhaishajya Ratnawali-10/22-24, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: water), Additional Information: Deepan-pachanarth(2) Medicine Name: Kushman Rasayana, Reference: Bhaishajya Ratnawali-13/95-101, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 7(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information: Rasayanartha | | 2 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: A)
(1) Medicine Name: KOLAKULATTHADI CHURNA, Reference: CHARAK SAMHITA-3/18, Route: Topical, Dosage Form: Churna/ Powder, Dose: 100(g), Frequency: od, Duration: 3 Days(2) Medicine Name: BALASHWAGANDHALAKSHADI TAILA, Reference: SAHASRAYOGA TAILAPRAKARANA, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days(3) Medicine Name: DASHMOOL KWATH, Reference: CHARAK SAMHITA-4/16, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 00(NA), Frequency: od, Duration: 7 Days(4) Medicine Name: CHHAGALYADI GHRITA, Reference: Bhaishajya Ratnavali-14/247-253, Route: Rectal, Dosage Form: Ghrita, Dose: 36(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Male |
| Details |
Male patients aged 5 to 12 years already diagnosed with Duchenne muscular dystrophy
weight atleast 20 kg at screening
Ambulant patients able to walk at least 50 meters without assistance
North Star Ambulatory Assessment NSAA total score atleast 40 percent of maximum
Stable cardiac and respiratory functions
Ability to comply with study procedures as determined by the investigator
Patients taking steroids would be taken after a washout period of 30 days
Written informed consent from parents OR legal guardians and assent from the child when appropriate
|
|
| ExclusionCriteria |
| Details |
Allergy or hypersensitivity to any components used in Panchakarma therapy including medicated oils and herbal preparations
Concurrent participation in any other interventional clinical trial or participation within 3 months prior to screening
3. Planned or expected spinal fusion surgery during the study period or previous spinal fusion surgery within the last 6 months
Prior gene therapy or cell based therapy for DMD
Any medical condition that in the investigators opinion might compromise patient safety or study results
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Kushmand Rasayana and Panchkarma therapies in managing ambulatory boys with DMD aged 5 to 12 years over a period of 2 months as measured by NSAA scale |
0,30,60,90 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess improvement in Peds3 Quality of Life Scale
|
0,30,60,90 day |
To assess changes in inflammatory markers and muscle enzyme levels
|
0,60,90 day |
To assess changes in respiratory functions using spirometry
|
0,60,90 day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
DMD is an inherited disorder caused by mutations in the dystrophin gene leading to progressive muscle weakness and wasting Symptoms begin at 2 to 3 years of age with difficulty climbing stairs and frequent falls In Ayurveda DMD is classified under inherited and genetic disorders affecting muscle tissue where vitiated Vata and impaired metabolic processes cause muscle degeneration and weakness The prevalence of DMD is about 1 in 5000 male births. Most mutations are deletions, followed by duplications and point mutations often occurring in hotspot regions of the dystrophin gene Currently there is no cure Glucocorticoids can improve muscle strength temporarily but have significant side effects With multidisciplinary management patients can survive into their forties Ayurveda offers scope for supportive management through Panchakarma therapies and herbal medicines The study aims to evaluate the effect of Kushmand Rasayana and Panchakarma in boys aged 5 to 12 years with DMD. Objectives Primary: Evaluate efficacy using North Star Ambulatory Assessment NSAA score Secondary: Assess improvement in quality of life using PedsQL score, changes in inflammatory markers and muscle enzymes, and respiratory functions using spirometry Study design Type: Prospective pilot trial Duration 3 months 2 months treatment plus 1 month follow u Sample size: 30 boys Location: AIIA New Delhi Analysis: Paired t test Interventions Chitrakadi Vati for digestion and metabolism for 3 days Kushmand Rasayana Avaleha 5 g for ages 5 to 8 years and 7 g for ages 9 to 12 years twice daily with lukewarm milk for 60 days Panchakarma therapies including Udwartana powder massage for 3 days Sarvang Abhyanga oil massage and Swedana steam for 7 days and Matra Basti medicated enema with Chhagalyadi Ghrita for 7 days repeated in two courses with a 20 day gap Inclusion criteria
Male children aged 5 to 12 years diagnosed with DMD weighing at least 20 kg ambulant and able to walk at least 50 meters with stable cardiac and respiratory functions and parental consent Exclusion criteria
Allergy to treatment components concurrent participation in other trials planned surgery prior gene or cell therapy or any condition compromising safety Ethical approval drug authentication and safety monitoring are ensured Rescue medications will be allowed if required The study seeks to validate traditional Ayurvedic therapies in improving quality of life delaying progression and providing integrative care for children with DMD |