| CTRI Number |
CTRI/2026/02/102725 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in children aged 7–12 years to compare Shatpushpa Churna and Saraswat Churna for improving memory |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL EVALUATION OF SHATPUSHPA CHURNA AND SARASWAT CHURNA ON MEMORY ENHANCEMENT IN CHILDREN (7–12 YEARS) USING PGI MEMORY SCALE |
| 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 Shahadat Khan |
| Designation |
Assistant Professor |
| 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
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166109123 |
| Fax |
|
| Email |
Shahadat1991khan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof 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
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8619892143 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof 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
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8619892143 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda Jodhpur Dr Sarvepalli Radhakrishnan Rajsthan Ayurved University Jodhpur Rajasthan INDIA 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda DSRRAU Jodhpur |
| Address |
PG Department of Kaumarbhritya Post graduate Institute of Ayurveda DSRRAU Jodhpur Rajasthan 342037 |
| 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 Shahadat Khan |
Post graduate Institute of Ayurveda DSRRAU Jodhpur |
PG Department of Kaumarbhritya Post graduate Institute of Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan 342037
Jodhpur
RAJASTHAN
342037
India
Jodhpur
RAJASTHAN |
9166109123
Shahadat1991khan@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 |
| Healthy Human Volunteers |
• Children of either sex aged 7–12 years with average or below-average PGI Memory Scale scores |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saraswata Churna, Reference: Bhaishjya Ratnawali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Madhu & Ghrita), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatpushpa Churna, Reference: Kashyap Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Madhu & Ghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of either sex aged 7–12 years with average or below average PGI Memory Scale scores.
2. Informed consent from parent or guardians.
|
|
| ExclusionCriteria |
| Details |
1. Children below 7 years and above 12 years.
2. Children with psychiatric disorders, neurological illnesses, or systemic chronic diseases.
3. Children on concurrent nootropic therapy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the PGI Memory Score of school going children |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Improvement in concentration and academic performance.
• Parent and teacher-reported quality of life enhancement.
|
8 weeks |
|
|
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)
|
01/04/2026 |
| 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 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
|
- Study
Type: Interventional,
randomized, open-label, two-arm comparative study.
- Control: Comparative, explorative
- Groups: Two groups (Saraswat vs. Shatpushpa).
- Research
Support: PG Scholars as
field investigators and data collectors.
- Baseline
Assessment: PGI Memory
Scale administration, consent forms, academic history.
- Drug
Intervention: 100
children randomized into two groups, drug given for 8 weeks.
- Follow-up: 4th, 8th & 12th
week.
- Data Entry
& Analysis: Using
SPSS software.
|