| CTRI Number |
CTRI/2025/09/094723 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Diagnostic
Other (Specify) [Panchkarma therapy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of Shastikshali Pind Sweda alone and Shashtikshali Pind Sweda combined with Sa-lavana Upanaha Swedana on reducing muscle stiffness (spasticity) in children with cerebral palsy. |
|
Scientific Title of Study
|
Clinical evaluation of Sa-lavana Upnaha Swedana and Shastikshali Pind Sweda on spasticity in 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 Prajjwal baranwal |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD no. 5, Patanjali Ayurved Hospital, Patanjali yogpeeth Phase 1, Roorkee road, Haridwar Uttarakhand, India
Kaumarbhritya deptt., Room no. 402, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali yogpeeth Phase 1, Roorkee road, Haridwar Uttarakhand, India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9568489263 |
| Fax |
|
| Email |
Prajjwalbaranwal31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nunna Sujatha |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD no. 5, Patanjali Ayurved Hospital, Patanjali yogpeeth Phase 1, Roorkee road, Haridwar Uttarakhand, India
Kaumarbhritya deptt., Room no 402, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali yogpeeth Phase 1, Roorkee road, Haridwar Uttarakhand, India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9897828745 |
| Fax |
|
| Email |
Sujatha.nunna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal thakur |
| Designation |
Assistant professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD no. 5, Patanjali Ayurved Hospital, Patanjali yogpeeth Phase 1, Roorkee road, Haridwar Uttarakhand, India
Kaumarbhritya deptt., Room no 402, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali yogpeeth Phase 1, Roorkee road, Haridwar Uttarakhand, India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9568242518 |
| Fax |
|
| Email |
Pt3544080@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali Yogpeeth Phase 1, Roorkee road, Haridwar, Uttarakhand, 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD no. 5, Patanjali Ayurved Hospital, Patanjali yogpeeth Phase 1, Roorkee road, Haridwar Uttarakhand, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Prajjwal baranwal |
Patanjali Ayurved Hospital |
Kaumarbhritya deptt, Room no. 402, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Patanjali yogpeeth phase 1, Haridwar, Uttarakhand, India, 249405
Hardwar
UTTARANCHAL |
9568489263
Prajjwalbaranwal31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Patanjali Ayurved College |
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 | Comparator Arm | Procedure | - | piNDasvedaH, पिण्डस्वेदः | (Procedure Reference: Charak samhita, Sutra sthan, Chapter 14th, Shloka 25, Procedure details: Shastik rice is boiled in decoction of Bala (Sida cordifolia) & milk; this rice is then tied in pieces of cloth to prepare packs.
These rice packs are heated in decoction of bala & milk. Warm rice packs are used to apply heat to the patient’s body & there by inducing perspiration.)
| | 2 | Intervention Arm | Procedure | - | piNDasvedaH, पिण्डस्वेदः with upanAhasvedaH (sAgniH) | (Procedure Reference: Sushrut samhita, Chikitsa sthan, Chapter 4th, Shloka 14-17, Procedure details: Shastikshali pind sweda along with Sa-lavana upnaha swedana for 14 days.
Patients will be advised to proceed with this therapy Shastikshali Pind Sweda & Sa
lavana Upnaha on empty stomach before taking the breakfast at morning.
After this procedure, the patient must take a rest in a chair for about 15 minutes.
Patients should avoid immediate exposure to cold breeze, open air & contact with
cold water after therapy. )
|
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in all sex in age group between 01yrs to 16yrs.
2. Children who have not received any form of modern intervention for spasticity at
least for last 3 months.
3. Patients fulfilling the diagnostic criteria will be included for the study.
4. Patient fit for Shastikshali Pind Sweda and Sa-lavana Upnaha. |
|
| ExclusionCriteria |
| Details |
1. Patients with non-spastic Cerebral Palsy.
2. Patients with any known major congenital anomalies like congenital heart disease
(CHD) etc.
3. Patients with other disease states like Acute infections, Severe systemic illness and
children with any Progressive neurologic anomalies.
4. Children with any other disease like Epilepsy or receiving any other drugs that may
interfere with the study outcome.
5. At the time of enrolment, if the child is found to be non-inclusive due to underlying
health condition or medication and thus not suitable for treatment will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in spasticity in children with cerebral palsy measured by Modified Ashworth Scale. |
Day 1
Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in range of motion and Functional abilities in affected part. |
Day 1
Day 14 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
25/09/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 (CP) is a non-progressive neuromotor disorder of posture and movement, with spasticity being the most common presentation. Current modern therapies for spasticity have limitations and side effects. Ayurveda mentions Shastikshali Pind Sweda and Sa-lavana Upnaha Swedana as effective modalities in Vata Vyadhi. This randomized comparative clinical trial will include 60 children (1–16 years) with spastic CP, divided into two groups: Group A – Shastikshali Pind Sweda alone, and Group B – Shastikshali Pind Sweda with Sa-lavana Upnaha Swedana. Intervention will be given once daily before breakfast for 14 days. The primary outcome will be reduction in spasticity assessed by the Modified Ashworth Scale (MAS) at Day 1 and day 14. Secondary outcomes include improvement in range of movement, functional abilities, and safety outcomes. The study aims to evaluate whether Sa-lavana Upnaha provides additional benefit over Shastikshali Pind Sweda in reducing spasticity in cerebral palsy. |