| CTRI Number |
CTRI/2024/03/063397 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Tratment] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate clinical efficacy of ayurvedic package in children suffering from cerebral palsy |
|
Scientific Title of Study
|
To Evaluate Clinical Efficacy of Ayurvedic Package in Children Suffering from 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 |
Deepti Yadav |
| Designation |
Dch (Ay) |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of kaumarbhritya balroga Faculty of Ayurveda Institute of Medical sciences Banaras hindu university Varanasi Uttarpradesh
OPD No. - 25, sir sunder lal hospital, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9569998982 |
| Fax |
|
| Email |
y.deepti7894@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P S Upadhyay |
| Designation |
Assosciate professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of kaumarbhritya balroga Faculty of Ayurveda Institute of Medical sciences Banaras hindu university Varanasi Uttarpradesh
OPD No. - 25, sir sunder lal hospital, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7355422083 |
| Fax |
|
| Email |
psupadhyay08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P S Upadhyay |
| Designation |
Assosciate professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of kaumarbhritya balroga Faculty of Ayurveda Institute of Medical sciences Banaras hindu university Varanasi Uttarpradesh
OPD No. - 25, sir sunder lal hospital, IMS, BHU
UTTAR PRADESH
221005
India |
| Phone |
7355422083 |
| Fax |
|
| Email |
psupadhyay08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kaumarbhritya / Balroga, OPD No. 25, Indian medicine wing, Sir sunderlal hospital, IMS, BHU, Varanasi |
|
|
Primary Sponsor
|
| Name |
Banaras HIndu University |
| Address |
Indian medicine wing, Sir sunderlal hospital, IMS, BHU, Varanasi |
| 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 P S Upadhyay |
Sir Sunderlal Hospital, IMS, BHU |
OPD No. - 25 (Bal Roga OPD), Kashyap Ward, Indian Medicine Wing
Varanasi
UTTAR PRADESH |
7355422083
psupadhyay08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, Institute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G809||Cerebral palsy, unspecified. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | abhyanga | (Procedure Reference: Charak samhita, Procedure details: 15 minute/day)
(1) Medicine Name: Ksheerbala oil, Reference: Sahasrayoga, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm | Procedure | - | abhyanga | (Procedure Reference: charak samhita, Procedure details: 15 minute/ day)
(1) Medicine Name: Mahanarayan oil, Reference: Bhaishajya ratnavali, Route: Topical, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Irrespective to sex.
Age between 1 to 10 years, suffering from any types of CP due to different etiology..
Whom parents have given consent for the participation of their kids in the proposed clinical trial.
|
|
| ExclusionCriteria |
| Details |
Any CP child suffering any associated life- threatening diseases, malignancy, congenital heart disease, HIV, diabetes, congenital genetic disorder etc.
Patient/parent, has quit denied participating between the clinical during study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
CBC LFT RFT CT brain MRI Brain Urine R M Stool R M EEG
|
Monthly follow up for 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anthropometry, milestones, muscle power, muscle tone, Deep tendon reflexes, Cortical thumb, Scissoring, drooling of saliva |
monthly follow up for 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
09/03/2024 |
| 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="2"
Days="0" |
|
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
|
Cerebral
palsy is defined as a nonprogressive neuromotor disorder of cerebral
origin. It includes heterogeneous clinical states of variable etiology and
severity ranging from minor incapacitation to total handicap. Cerebral palsy (CP) is the leading cause of
childhood disability affecting function and development.
Motor disorders of CP are often accompanied by
disturbances of sensation, perception, cognition, communication and behavior. Most
of the cases have multiple neurological deficits and variable mental handicap.
It is difficult to estimate the precise magnitude of the problem since mild
cases are likely to be missed.
Approximately
1-2 per 100 live births is a reasonable estimate of the incidence.
The global prevalence of CP is 2:1000 of the many
types and subtypes of CP, none has any known “cure.†Ayurveda has a separate
branch of clinical specialization concerning child healthcare known as
KaumÄrabhá¹›tya. There is no one to one correlation available in Ayurvedic
classics with CP, but there are many conditions and some causative factors
linked to etiopathology for such type of disease condition described in many
chapters in different texts.
|