| CTRI Number |
CTRI/2025/02/080535 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Brihat Saraswat Churna with or without Brahmi Taila Pratimarsh Nasya for Managing Hyperactivity in Children |
|
Scientific Title of Study
|
Comparative exploratory study on Brihat Saraswat Churna with or without Brahmi Taila Pratimarsh Nasya in the management of Hyperactivity 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 Himanshu Soni |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute Of Ayurved DSRRAU,Jodhpur |
| Address |
PG Department of Kaumarbhritya Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadwad Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
342037
India |
| Phone |
6376901051 |
| Fax |
|
| Email |
ayur.trick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Harish Kumar Singhal |
| Designation |
Professor Head Of Department Kaumarbhritya |
| Affiliation |
Post Graduate Institute Of Ayurved DSRRAU,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
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636622206 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Harish Kumar Singhal |
| Designation |
Professor Head Of Department Kaumarbhritya |
| Affiliation |
Post Graduate Institute Of Ayurved DSRRAU,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
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636622206 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 342037 Rajasthan INDIA |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
| Address |
PG Department of Kaumarbhritya Post Graduate Institute of Ayurved DSRRAU Jodhpur 342037 Rajasthan 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 Himanshu Soni |
Sanjivani Ayurved Hospital |
OPD NO 4 Department of Kaumarbhritya DSRRAU Jodhpur Nagaur Road Kadwad Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
6376901051
ayur.trick@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:F901||Attention-deficit hyperactivity disorder, predominantly hyperactive type. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: BRIHAT SARASWAT CHURNA, Reference: Gadanigrah Churnaadhikar Page No 173 Verse No 155 to 158 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Ghrita and Madhu), Additional Information: - | | 2 | Comparator Arm | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: Rastantrasaar evam Sidhhaprayog Sangraha under the 18th chapter Unmada, Procedure details: Pratimarsh Nasya will be given as 2 drops in each nostril two times a day for 21 days)
(1) Medicine Name: Brahmi tail, Reference: Rastantrasaar evam Sidhhaprayog Sangraha under the 18th chapter Unmada, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: bd, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1 Individual between age group of 6 to 15 years of both sexes
2 Individual satisfying Vanderbilt Assessment scale
3 Individual having borderline or more IQ will be considered |
|
| ExclusionCriteria |
| Details |
1 Individual below 6 years and above 15 years of age
2 Children with schizophrenia Bipolar Disorders Pervasive Developmental Disorders Oppositional Defiant disorders etc will be excluded from
the present study
3 Children having genetic disorder
4 Children suffering from any severe or acute infections |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Brihat Saraswat Churna and Brahmi Taila Pratimarsh Nasya may be effective to ameliorate
symptoms of Hyperactivity Disorder in 100 childrens |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Brihat Saraswat Churna & Brahmi Taila Pratimarsh Nasya may be helpful to reduce dropouts from schools
2 Brihat Saraswat Churna & Brahmi Taila Pratimarsh Nasya may be provide a safe & effective treatment
3 Brihat Saraswat Churna & Brahmi Taila Pratimarsh Nasya may be helpful to reduce
comorbidities |
21 Days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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="0"
Days="21" |
|
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- 100 Intervention Groups - Two group Sample Size - 50 Children in each group
Type of Study- Open Labelled
Drug- Group 1st Brihat Saraswat Churna with Brahmi Taila Pratimarsha nasya and Group 2nd Brihat Saraswat ChurnaDose- Brihat Saraswat Churna will be given in three divided doses as per Young Formula While Brahmi Tail Pratimarsha nasya will be given 2 drops in each nostrils
Anupana- Oral medicine will be given with Ghrita and Madhu
Route- Brihat Saraswat Churna- Oral Route
Brahmi Tail Pratimarsha nasya- Nasal Route
Randomization- Block randomization
Duration of Study- 21 days with follow up of 21th day and 42th day
Follow up- Every fortnightly during the study and 21 days after completion of the study |