CTRI

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CTRI Number

CTRI/2023/04/051348 [Registered on: 06/04/2023] Trial Registered Prospectively

Last Modified On:

04/04/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Screening

Study Design

Non-randomized, Active Controlled Trial

Public Title of Study

This study aims to set standard ayurvedic treatment protocol in patients of cerebral palsy.

Scientific Title of Study

"A clinical study to assess the effectiveness of an ayurvedic treatment protocol in patients of cerebral palsy"

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Aakanksha Jaiswal
Designation	M.D.(Ay)Scholar
Affiliation	Institute of Medical Sciences,Banaras Hindu University
Address	Department of Kaumarbhritya - Balrog Faculty of Ayurveda ,Institute of Medical Sciences Banaras Hindu University,Varanasi Varanasi UTTAR PRADESH 221005 India
Phone	8299353065
Fax
Email	aakankshajaiswal14@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Vaibhav Jaiswal
Designation	Assistant Professor
Affiliation	Institute of Medical Sciences,Banaras Hindu University
Address	Department of Kaumarbhritya - Balrog Faculty of Ayurveda ,Institute of Medical Sciences Banaras Hindu University,Varanasi Varanasi UTTAR PRADESH 221005 India
Phone	8004232639
Fax
Email	drvaibhav29@gmail.com

Details of Contact Person
Public Query

Name	Dr Vaibhav Jaiswal
Designation	Assistant Professor
Affiliation	Institute of Medical Sciences,Banaras Hindu University
Address	Department of Kaumarbhritya - Balrog Faculty of Ayurveda ,Institute of Medical Sciences Banaras Hindu University,Varanasi Varanasi UTTAR PRADESH 221005 India
Phone	8004232639
Fax
Email	drvaibhav29@gmail.com

Source of Monetary or Material Support

Kaumarbhritya/Balroga OPD No 25 Indian Wing Sir Sunderlal Hospital IMS BHU Varanasi

Modern Pediatrics OPD Sir Sunderlal hospital IMS BHU Varanasi

Primary Sponsor

Name	Banaras Hindu University
Address	Sir Sunderlal Hospital,Institute of Medical Sciences,Banaras Hindu University,Varanasi
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Vaibhav Jaiswal	Institute of Medical Sciences,Banaras Hindu University	Department of Kaumarbhritya/balroga Faculty of Ayurveda,Institute of Medical Sciences,Banaras Hindu University Varanasi UTTAR PRADESH	8004232639 drvaibhav29@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethical Committee, Institute of Medical Sciences,Banaras Hindu University Varanasi	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:F848\|\|Other pervasive developmental disorders. Ayurveda Condition: MARMAVIDDHAH/MARMABIGHATAH/MARMAKSHATAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm (Non Ayurveda)		-	Physiotherapy	Physiotherapy procedure will be done in control group
2	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Ashwagandhadi ksheerpaka, Reference: NA, Route: Oral, Dosage Form: Ksheerpaka, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Years, anupAna/sahapAna: No, Additional Information: -
3	Intervention Arm	Drug	Classical		(1) Medicine Name: vacha churna, Reference: bhava prakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Years, anupAna/sahapAna: Yes(details: -madhu), Additional Information: -
4	Intervention Arm	Drug	Classical		(1) Medicine Name: saraswata granules, Reference: bhaishjya ratwanawali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Years, anupAna/sahapAna: Yes(details: -milk), Additional Information: -
5	Intervention Arm	Drug	Classical		(1) Medicine Name: kapikachu churna, Reference: -bhavprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Years, anupAna/sahapAna: Yes(details: -madhu), Additional Information: -
6	Intervention Arm	Drug	Classical		(1) Medicine Name: swarnprashan, Reference: kashyap samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -
7	Intervention Arm	Drug	Classical		(1) Medicine Name: Kalyanak ghrita, Reference: charak samhita, Route: Oral, Dosage Form: Ghrita, Dose: 1(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Years, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	1.00 Year(s)
Age To	10.00 Year(s)
Gender	Both
Details	1.Child who has been diagnosed as case of any type of cerebral palsy due to different etiology or perinatal asphyxia, irrespective of sex and age between 1 year to 10 years. 2.Children with developmental delay,delayed milestones and disability with mild, moderate, or severe degree. 3.Patients who have underwent cerebral imaging like CT scan/MRI, EEG and diagnosed as CP (HIE sequel, PVL etc.) 4.Those who had already previously underwent physiotherapy and other occupational therapies.

ExclusionCriteria

Details

1.Children below 1 year and above 10 years.Any patient of cerebral palsy suffering from any associated acute systemic disorder, infective disorder,lethal congenital disorder, myopathy of genetic origin,cp of genetic disorder.
2.Child suffering with progressive movement disorders or psychomotor retardation due to progressive degenerative disorder, metabolic,intracranial space occupying lesion.
3.Accompanied by other diseases (i.e., congenital muscular disease, hereditary disease, progressive central nervous system diseases, cancer, severe heart disease, or severe infectious disease such as TB, meningitis.
4.Other Behavioral disorder (ADHD,Autism) and Syndromic (Down syndrome,Klinefelter ,Turner Syndrome).

Method of Generating Random Sequence

Other

Method of Concealment

Other

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
MRI BRAIN	BEFORE INTERVENTION AFTER 3 MONTHS AFTER 12 MONTHS

Secondary Outcome

Outcome	TimePoints
Assessment of patients will be done by using following scales and grading systems :- 1.Modified Ashworth scale score for tone. 2.GMFCS (Gross Motor Function Classification System) for CP 3.Penn Spasm frequency scale to assess intensity of spasm 4.Manual Ability Classification System (MACS) 5. Goniometeric evolution to assess the range of motion 6.Anthropometry assessment.	BEFORE INTERVENTION AFTER 3 MONTHS AFTER 12 MONTHS

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 1/ Phase 2

Date of First Enrollment (India)

15/04/2023

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

Not Yet

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Although previously many research works had been done on cerebral palsy with various Ayurvedic drugs.But there is no evidence based research in children which could justify pre and post MRI Brain changes caused by the ayurvedic intervention.Many parents are confused while providing treatment for their CP child.Still ayurvedic management in the CP is masked by the modern and the people are not much awared of the miracular result in the treatment of CP patients by ayurveda.Physiotherapy and other occupational therapy are mainly provided as a allopathic treatment protocol but considerable changes in the gross motor and fine motor milestones are not noticed.Still there is no any comparative study regarding the ayurvedic and the allopathic intervention in CP patients .Even no standard ayurvedic treatment protocol have been set till date in patients of cp.This study may help to set a definite treatment protocol if got desired changes in radiological finding.