| CTRI Number |
CTRI/2025/04/084274 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Trial to Evaluate the Effectiveness of Shankhapushpi Syrup with or without Applied Behavior Analysis Therapy in Children with Autism Spectrum Disorder |
|
Scientific Title of Study
|
Two Arm Open Label Prospective Clinical Study to Evaluate the Efficacy of Shankhapushpi Syrup with and without Applied Behavior Analysis Therapy in Autism Spectrum Disorder in Children |
| 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 Kamlesh Kumar Meena |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurveda Jodhpur |
| Address |
PG Department of Kaumarbhritya Post Graduate Institute of
Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan
342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8559877381 |
| Fax |
|
| Email |
kmeena508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Harish Kumar Singhal |
| Designation |
Professor & HOD |
| Affiliation |
Post Graduate Institute of Ayurveda Jodhpur |
| Address |
Room no 155 PG Department of Kaumarbhritya Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8619892143 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Harish Kumar Singhal |
| Designation |
Professor & HOD |
| Affiliation |
Post Graduate Institute of Ayurveda Jodhpur |
| Address |
Room no 155 PG Department of Kaumarbhritya Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan 342037 India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8619892143 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan
Ayurved University Campus Kadvad Jodhpur Rajasthan 342037 India
|
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
| Address |
PG Department of Kaumarbhritya Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan
Ayurved University Campus Kadvad Jodhpur Rajasthan 342037 India |
| Type of Sponsor |
Government 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 Kamlesh Kumar Meena |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
PG Department of Kaumarbhritya Post Graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan
Ayurved University Campus Kadvad Jodhpur Rajasthan 342037 India
Jodhpur
RAJASTHAN |
8559877381
kmeena508@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Post Graduate Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Applied Behavior Analysis Therapy | Applied Behavior Analysis Therapy for 60 days with Shankhpushpi Syrup | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shankhpushpi Syrup, Reference: Charak Samhita Chikitsasthan Chapter 1 Rasayana Adhyay Paad 3 Karapratichiya Rasayanapad Shloka 30, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 30(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1 Diagnosed cases of Autism satisfying DSM V criteria of both sexes
2 Patients with score above 70 in Indian Scale for assessment of Autism (ISAA)
3 Age between 3 to 16 years of both sexes. |
|
| ExclusionCriteria |
| Details |
1 Patient with score below 70 in Indian Scale for assessment of Autism (ISAA)
2 ASD medications from any other system
3 Patients having mental retardation, cerebral palsy
4 Patients having presence of other organic or psychotic neurological disorder
5 Patients having pervasive developmental disorder
6 Patients having hearing and visual impairment
7 Patients having acute and chronic systemic illness such as renal diseases, hepatic
dysfunction, juvenile diabetes mellitus etc
8 Patients having congenial disorders, genetic syndrome like fragile X syndrome, turner
syndrome etc
9 Patients having progressive and non-progressive neuromuscular disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shankhpushpi Syrup with and without Applied Behavior
Analysis Therapy will be effective. |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Shankhpushpi Syrup with and without Applied Behavior Analysis Therapy will
be helpful to improve quality of life of children suffering from ASD.
2. Change in ISAA score/ DSM V score. |
60 Days |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| 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="0"
Months="2"
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
|
Number of Patient- 40
Type of Study- Two Arm Open label Prospective Clinical Study
Group :- Two Groups:- Group A :- Shankhpushpui syrup Group B - Shankhpushpui syrup with Applied Behavior Analysis Therapy
Drug- Shankhapushpui syrup
Dose- Dose will be calculated according to Young Formula in three divided doses.
Route- Shankhpushpui syrup - Oral Route
Anupana- Oral medicine will be given with Luke warm milk
Randomization- Simple Random Sampling
Duration of Study- 60 days
Follow up- Every fortnightly during the study and 120 days after completion of the study. |