| CTRI Number |
CTRI/2026/02/104975 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
27/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Haritakyadi Avaleha and Shatpushpadi Churna for Boosting Brain Power in Children |
|
Scientific Title of Study
|
A comparative clinical study on the efficacy of Haritakyadi Avleha and Shatpushpadi Churna as Medhya Rasayana in school going 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 Yogesh Ratan Bagauriya |
| 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 India 342037
Jodhpur
RAJASTHAN
342037
India |
| Phone |
09079091891 |
| Fax |
|
| Email |
yogeshratan2222@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 |
PG Department of Kaumarbhritya Post Graduate Institute of
Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan India 342037
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 |
PG Department of Kaumarbhritya Post Graduate Institute of
Ayurveda Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Campus Kadvad Jodhpur Rajasthan India 342037
RAJASTHAN
342037
India |
| Phone |
8619892143 |
| 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 Yogesh Ratan Bagauriya |
Post Graduate Institute of Ayurved DSRRAU Jodhpur |
PG Department of
Kaumarbhritya Post
Graduate Institute of
Ayurved DSRRAU
Jodhpur Nagaur
Road Kadwad Jodhpur
Rajasthan
Jodhpur
Jodhpur
RAJASTHAN |
9079091891
yogeshratan2222@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 with average memory level (PGI Memory Scale score: 40–60/100) and normal IQ. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatpushpadi Churna, Reference: Kashyapa Samhita, Kalpa Sthana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ghrita and Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritakyadi Avleha, Reference: Ashtanga Sangraha, Uttara Tantra., Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ghrita and Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 6–12 years, of either sex.
2.Children with average memory level and normal IQ.
3.Children who are physically and mentally healthy. |
|
| ExclusionCriteria |
| Details |
1. Children below 6 years or above 12 years of age.
2. Children with systemic disorders (e.g., gastrointestinal, neurological, or metabolic disorders).
3. Children with learning disabilities.
4. Children with mental illnesses such as schizophrenia, epilepsy, etc.
5. Children with mental retardation due to genetic or congenital causes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in memory score |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Standardization & quality control parameters documented
2. Improvement in IQ score
3. Change in attention span performance
4. Improved attention–concentration measures
5. Literary correlation between Ayurvedic Smriti & modern cognitive domains |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
14/05/2026 |
| 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="0"
Days="30" |
|
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
|
Study Design:- Interventional, two-arm, open-label, comparative clinical study. Study Setting: • The study will be conducted in the Department of Kaumarbhritya, Sanjeevani Hospital, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University (DSRRAU), Jodhpur. • Additionally, primary schools in Jodhpur and surrounding areas will serve as recruitment sites. •Detailed clinical and demographic information of participants will be recorded in a specially designed case record form (CRF). Study Groups: • Participants will be randomly allocated into two groups. Randomization Method: • Simple randomization using computer-generated random numbers. Sample Size: A total of 80 school-going children will be enrolled (40 in each group). Study Duration: • 30 days of intervention per participant. Follow-up and Monitoring: • Participants will be assessed fortnightly during the intervention period. • Post-intervention follow-up will be conducted on the 45th day and the 60th day to evaluate sustainability of outcomes. Study End Point: • Efficacy assessment of Haritakyadi Avleha and Shatpushpadi Churna as Medhya Rasayana. |