| CTRI Number |
CTRI/2026/03/105915 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Yog Basti] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study on the Effect of Rasnadi Ghrita and Yog Basti in Children with Spastic Cerebral Palsy |
|
Scientific Title of Study
|
Clinical Evaluation of Rasnadi Ghrita and Yog Basti in Spastic Cerebral Palsy in Children: A Single Arm Open Label 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 Namita Gundu Pawar |
| Designation |
MD SCHOLAR |
| Affiliation |
Post Graduate Institute of Ayurveda |
| Address |
PG Department of Kaumarbhritya Post Graduate Institute of
Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved
University Campus Kadvad Jodhpur Rajasthan India Jodhpur
RAJASTHAN 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9921841178 |
| Fax |
|
| Email |
namitagpawar47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Harish Kumar Singhal |
| Designation |
Head Of Department Kaumarbhritya |
| Affiliation |
Post Graduate Institute of Ayurveda |
| Address |
Room no 155 PG Department of Kaumarbhritya Post Graduate
Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan
Ayurved University Campus Kadvad Jodhpur Rajasthan 342037
India
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8619892143 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Harish Kumar Singhal |
| Designation |
Head Of Department Kaumarbhritya |
| Affiliation |
Post Graduate Institute of Ayurveda |
| Address |
Room no 155 PG Department of Kaumarbhritya Post Graduate
Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan
Ayurved University Campus Kadvad Jodhpur Rajasthan 342037
India
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8619892143 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur 342037 Rajasthan INDIA |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
| Address |
PG Department of Kaumarbhritya Post Graduate Institute of Ayurved
DSRRAU Jodhpur 342037 Rajasthan INDIA |
| 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 Namita Gundu Pawar |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
PG Department of
Kaumarbhritya Post
Graduate Institute of
Ayurved DSRRAU
Jodhpur Nagaur
RoadKadwad Jodhpur
Rajasthan
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
9921841178
namitagpawar47@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Post Graduate Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G800||Spastic quadriplegic cerebral palsy. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoga-bastiH, योग-बस्तिः | (Procedure Reference: Sahasrayogam, Procedure details: Yog basti have 8 bastis which includes 5 anuvasan & 3 niruha
Anuvasan by shuddha bala taila dose is 102 ml
Total duration 10 days)
(1) Medicine Name: shuddha bala taila, Reference: Sahasrayogam, Route: Rectal, Dosage Form: Taila, Dose: 102(ml), Frequency: od, Duration: 10 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasnadi Ghrita:, Reference: Ashtanga Hridaya, Chikitsa Sthana 21/57, Route: Oral, Dosage Form: Ghrita, Dose: 15.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 16 Days, anupAna/sahapAna: Yes(details: -Luke warm milk), Additional Information: - | | 3 | Intervention Arm | Procedure | - | yoga-bastiH, योग-बस्तिः | (Procedure Reference: Gudartha Dipika, Uttara Khanda 6/33, Procedure details: Yog basti includes 5 anuvasan & 3 niruha Niruha basti is given by siddha basti for 6 days)
(1) Medicine Name: . Siddha Basti , Reference: Gudartha Dipika, Uttara Khanda 6/33, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 230(ml), Frequency: od, Duration: 6 Days |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1 to 16 years of both sexes
Clinical diagnosis of spastic cerebral palsy based on characteristic signs and symptoms
Mild to moderate intellectual disability associated with cerebral palsy
Parents or guardians willing to participate and commit to study follow up for at least 3 months
|
|
| ExclusionCriteria |
| Details |
Children aged below 1 year or above 16 years
Presence of chronic systemic diseases such as Hridroga Prameha Vrikka Yakrit Vikara or any other congenital disease
Children with progressive neurological disorders
Severe physical disability that limits participation
Other types of cerebral palsy such as dyskinetic extrapyramidal or mixed forms
Quadriplegic cerebral palsy with status epilepticus
History of recent orthopedic surgery casting splinting or fixed contractures
Caregivers unwilling to provide informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Therapeutic efficacy of Rasnadi Ghrita and Yog Basti in improving motor function in spastic cerebral palsy |
96 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction of spasticity (MAS) Efficacy on Ayurvedic and modern clinical parameters (GMFCS, ADL, quality of life) Analytical standardization and quality assessment of trial drugs
|
96 DAYS |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
19/04/2026 |
| 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="6" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
| Number of Groups | One | | Sample Size | 30 children diagnosed with spastic cerebral palsy | | Purpose | Evaluate efficacy and safety of Rasnadi Ghrita and Yog Basti | | Purva Karma (Pre-procedure) | Deepan and pachan will be done as required Duration: 5 days Bahya Snehana: Sarvanga Abhyanga (25–30 min)Swedana: Sarvanga Swedana (10–15 min) | | Trial Drugs | Oral Medicine: Rasnadi Ghrita Anuvasana Basti: Shuddha Bala Taila Niruha Basti: Siddha Basti | | Dosage | Rasnadi Ghrita: 2 divided doses for 16 days (3.6–27.4 g depending on age, 1–16 yrs) Anuvasana/Niruha Basti: Classical schedule | | Anupana (Vehicle) | Luke warm milk for oral Rasnadi Ghrita | | Route of Administration | Rasnadi Ghrita: Oral ,Yog Basti: Per Rectum | | Duration of Study | 96 days (32-day active trial + 64-day follow-up / Parihar Kal) | | Monitoring | Weekly during the active trial phase | | Follow-up | Day 32 (end of trial), Day 96 (end of follow-up) | |