| CTRI Number |
CTRI/2025/03/082832 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Guduchi Churna and Vatahara Diet in Pediatric Cerebral Palsy |
|
Scientific Title of Study
|
Clinical efficacy of the combination of Guduchi Churna and Vatahara diet in Pediatric Cerebral Palsy -A Randomized Controlled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saurabh Subhash bagal |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed to Be University) College of Ayurved and Hospital |
| Address |
Bharati Vidyapeeth (Deemed to Be University) College of Ayurved and Hospital Department of Kaumarbhritya OPD No 9 Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7020430484 |
| Fax |
|
| Email |
saurabh.bagal-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preetham Pai |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to Be University) College of Ayurved and Hospital |
| Address |
Bharati Vidyapeeth (Deemed to Be University) College of Ayurved and Hospital Department of Kaumarbhritya OPD No 9 Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9765417555 |
| Fax |
|
| Email |
preetham.pai@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preetham Pai |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to Be University) College of Ayurved and Hospital |
| Address |
Bharati Vidyapeeth (Deemed to Be University) College of Ayurved and Hospital Department of Kaumarbhritya OPD No 9 Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9765417555 |
| Fax |
|
| Email |
preetham.pai@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to Be University) College of Ayurveda and hospital, katraj Pune 411043, India |
|
|
Primary Sponsor
|
| Name |
Saurabh bagal |
| Address |
Bharati Vidyapeeth (Deemed to Be University) College of Ayurveda and Hospital Department of Kaumarbhritya OPD No 9 Dhankawadi Pune
and Hospital Dhankawadi Pune 411043 |
| Type of Sponsor |
Private 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 Saurabh Bagal |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Kaumarbhritya OPD No 9 Dhankawadi pune 411043
Pune
MAHARASHTRA |
7020430484
saurabh.bagal-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Ethics Committee[BV(DU)COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F843||Other childhood disintegrative disorder. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Physiotherapy | Two sessions per week of physiotherapy will be advised for three months | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchi Churna, Reference: Charak Chikitsa Rasayan Adhyay 1/3/30, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Madhu/Ghrita), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
subjects suffering from Cerebral Palsy in the age group – 2 TO 10 yrs.
All types of Cerebral Palsy will be included. |
|
| ExclusionCriteria |
| Details |
1. Subjects suffering from grade 5 spasticity and contractures.
2. Subjects suffering from metabolic syndrome,
3. Suffering from developmental delays due to other syndromes like Down syndrome, Williams syndrome, West syndrome.
4. Children with severe infectious diseases such as TB, Meningitis, major congenital malformations such as congenital heart disease (CHD). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To clinically assess the efficacy of combination of Guduchi Churna and Vatahara Diet in motor function in Cerebral Palsy |
On Baseline, 30th day, 60th day, 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of both gross motor milestone and fine motor milestone while also aiming to achieve the developmental milestone |
On Baseline, 30th day, 60th day, 90th day |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
28/03/2025 |
| 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="11"
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 (CP) is the most common cause of physical disability in children, affecting 2-2.5 per 1,000 live births globally, with a prevalence of 2.95 per 1,000 live births in India. CP is a group of non-progressive disorders that impair physical movement, with associated disturbances in sensation, perception, cognition, communication, behavior, and epilepsy. It is classified into four main types: Spastic (70%), Athetoid/Dyskinetic (15%), Ataxic (5%), and Mixed (10%).
Despite advancements in newborn care, the management of CP remains challenging. There is currently no cure for CP, as the brain damage causing motor dysfunction is irreversible. Treatment focuses on improving the quality of life and reducing symptoms through interdisciplinary approaches. These include physical therapy, occupational therapy, neurodevelopmental treatments, pharmacological interventions, and sometimes surgery. Techniques like Neurodevelopmental treatment-Bobath, Constraint-Induced therapy, electrical stimulation, and the use of orthoses are commonly employed. However, research on the efficacy of traditional treatments, including physiotherapy, has been inconclusive. There is also ongoing debate regarding the effectiveness of therapeutic exercises like passive stretching in children with spasticity, as evidence remains weak.
In Ayurveda, CP is not recognized as a specific disease but is viewed through the lens of Vata Vyadhi, a disorder of the Vata dosha. CP symptoms are believed to result from an imbalance in Vata, which can be pacified through therapies like Snehana, Swedana, and Basti. Ayurvedic treatments for CP emphasize using medications that promote digestion, stimulate growth, and cleanse the body’s microchannels. Diets that are Vata-alleviating and Brihmana (restorative) are recommended, such as those containing Masha (black gram), Yava (barley), and Godhuma (wheat), which are believed to provide nourishment, stability, and vitalizing effects.
The Medhya (intellect-promoting) action of ’Guduchi’ (Tinospora cordifolia) is also highlighted as a potentially beneficial treatment in CP. Guduchi is known for its cognitive-enhancing properties and may help in neurological recovery. Studies suggest that Guduchi improves memory and enhances learning, possibly making it useful for cognitive and motor development in children with CP. It also balances the Tridoshas (Kapha, Pitta, and Vata), which could help restore the neurological functions affected in CP.
Despite the potential of Guduchi and other Ayurvedic treatments, further clinical trials are needed to evaluate their efficacy in managing CP. Research on combining Guduchi with a ’Vataghan diet’ (Vata-alleviating diet) for treating pediatric CP is still lacking. The article concludes by stressing the need for more research on the integration of Ayurvedic and conventional treatments for better management of Cerebral Palsy.
|