| CTRI Number |
CTRI/2026/02/103233 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Vardhamana Nagabala Rasayana and Samvardhana ghrita in children with cerebral palsy. |
|
Scientific Title of Study
|
Randomised open-label clinical study on the efficacy of vardhamana nagabala rasayana in comparison with samvardhana ghrita on neuromuscular activity in children with cerebral palsy. |
| 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 Monika Singh Chauhan |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic science and Research |
| Address |
Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic
science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura.Bangalore KARNATAKA, 560082 India
Bangalore
KARNATAKA
560082
India |
| Phone |
9113847371 |
| Fax |
|
| Email |
monikasinghchauhan09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudheer B R |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bangalore. |
| Address |
Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic
science and Research Hospital, 21st K.M. Kanakapura Road,
Udayapura.
Bangalore
KARNATAKA
560082
India |
| Phone |
9900175777 |
| Fax |
|
| Email |
sudheerbrao@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudheer B R |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research, Bangalore. |
| Address |
Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic
science and Research Hospital, 21st K.M. Kanakapura Road,
Udayapura.
Bangalore
KARNATAKA
560082
India |
| Phone |
9900175777 |
| Fax |
|
| Email |
sudheerbrao@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Monika Singh Chauhan |
| Address |
Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic
science and Research Hospital, 21st K.M. Kanakapura Road,
Udayapura.
Bangalore
KARNATAKA
560082
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Monika |
Sri Sri College of Ayurvedic and Research Hospital, Bangalore |
Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic
science and Research Hospital, 21st K.M. Kanakapura Road,
Udayapura.
Bangalore
KARNATAKA |
9113847371
monikasinghchauhan09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G809||Cerebral palsy, unspecified. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: VARDHAMANA NAGABALA RASAYANA, Reference: KASHYAPA SAMHITA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.25(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 19 Days, anupAna/sahapAna: Yes(details: -MILK), Additional Information: - DRUG DOSE WILL BE GIVEN IN VARDHAMANA FORMAT OF RASAYANA (DRUG DOSE WILL BE INCREASED DAILY UPTO 19 DAYS) | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SAMVARDHANA GHRITA, Reference: KASHYAPA SAMHITA, Route: Oral, Dosage Form: Ghrita, Dose: 2.25(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -MILK), Additional Information: -AGE SPECIFIC CALCULATED DRUG DOSE WILL BE GIVEN |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants between the age group of 3 years to 7 years.
2. Participants diagnosed with cerebral palsy as per ICD 11 criteria
3. Participants diagnosed with spastic hemiplegia, diplegia, dyskinetic, ataxic cerebral palsy.
4. Participants whose parents or legal guardians are willing to sign the written informed consent form.
5. Participants who have been already diagnosed with cerebral palsy and are on supportive treatments like physiotherapy, ADL (activities of daily living) training will be included. |
|
| ExclusionCriteria |
| Details |
1. Children of CP with major congenital anomalies
2. Children who are currently on medications like baclofen, diazepam, tizanidine.
3. Children with Cerebral palsy associated with other illness like respiratory complications, orthopedic complications, contractures, severe neuromuscular conditions.
4. Children diagnosed with spastic quadriplegia. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant improvement in neuromuscular activity in participants with cerebral palsy assessed with
Coordination – GMFM 66 (Gross Motor Function Measure)
power-muscle power grading
balance-paediatric balance scale |
Group A- 0th, 19th, 27th, 35th day
Group B- 0th, 30th, 45th, 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Generation of in – depth analyzed data on the different aspects of the disease.
Generation of data on possible unexpected drug reaction. |
Group A- 0th, 19th, 27th, 35th day
Group B- 0th, 30th, 45th, 60th 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2026 |
| 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="1"
Months="0"
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
|
Cerebral palsy is a non-progressive neurodevelopmental disorder characterized by impairment of movement, posture, and neuromuscular activity due to insult to the developing brain. Children with cerebral palsy commonly present with abnormal muscle tone, delayed motor development, and functional limitations, significantly affecting daily activities and quality of life. In Ayurveda, such congenital neuromuscular conditions are described under Murdhnabhighata Janya Vata Vyadhi, predominantly involving Vata Dosha vitiation. Rasayana therapy is indicated to enhance strength, nourishment, and functional development of the neuromuscular system. The present study is a randomised, open-labelled, comparative clinical trial conducted to evaluate the efficacy of Vardhamana Nagabala Rasayana and Samvardhana Ghrita on neuromuscular activity in children with cerebral palsy. Eligible children fulfilling the inclusion criteria will be randomly allocated into two groups. Group A will receive Vardhamana Nagabala Rasayana for 19 days, and Group B will receive Samvardhana Ghrita for 30 days. The selected interventions possess Balya, Medhya, and Vata-shamaka properties, which may help in improving neuromuscular function. Clinical assessment will be carried out before and after intervention using standardized paediatric neuromuscular and motor function assessment scales. The outcomes of both groups will be statistically analysed and compared to assess improvement in neuromuscular activity and functional performance. |