| CTRI Number |
CTRI/2025/07/090482 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [In Vitro and Double Blind Placebo Controlled Study] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to evaluate effect of AYUSH(Traditional )intervention for memory enhancement in children. |
|
Scientific Title of Study
|
An In Vitro Acetylcholinesterase inhibition Activity and A Double Blind Placebo Controlled Study of Guduchyadi Yoga on Scholastic Performance |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amruta M Deokar |
| Designation |
PhD Scholar |
| Affiliation |
DrDY Patil College of Ayurved & Research Centre |
| Address |
Dr DY Patil College Rd Sant Tukaram Nagar Pimpri Colony Pimpri Chinchwad Maharashtra 411018
Dr DY Patil College Rd Sant Tukaram Nagar Pimpri Colony Pimpri Chinchwad Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8779541798 |
| Fax |
|
| Email |
vd.amrutadeokar02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepak Khawale |
| Designation |
Professor Department of Kaumarbhritya |
| Affiliation |
DrDY Patil College of Ayurved & Research Centre |
| Address |
Dept Of Kaumarbhritya
Dr DY Patil College Rd Sant Tukaram Nagar Pimpri Colony Pimpri Chinchwad Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9923220055 |
| Fax |
|
| Email |
drdeepak77@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Khawale |
| Designation |
Professor Department of Kaumarbhritya |
| Affiliation |
DrDY Patil College of Ayurved & Research Centre |
| Address |
Dept Of Kaumarbhritya
Dr DY Patil College Rd Sant Tukaram Nagar Pimpri Colony Pimpri Chinchwad Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9923220055 |
| Fax |
|
| Email |
drdeepak77@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amruta Deokar |
| Address |
Dr DY Patil College of Ayurved and Research Centre,Pune 411018 |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 |
| DrAmruta Deokar |
Kaumarbhritya OPD ,Department of Kaumarbhritya |
Dr DY PATIL COLLEGE OF AYURVED AND ESEARCH CENTER SANT TUKARAM NAGAR PIMPRI-CHINCHWAD PUNE 411018
Pune
MAHARASHTRA |
8779541798
vd.amrutadeokar02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Children |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Guduchyadi Yog, Reference: BhaishyajyaRatnavali-Rasayanadhikar, Route: Oral, Dosage Form: Khanda /Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Khanda/Granules, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Healthy school going children between the age group of 11-16years
Children will be enrolled irrespective of gender religion socio-economic status.
Children ready to sign assent and whose parents/legal guardian ready to sign Consent Form and willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Known Case Of Chronic debilitating illnesses
Children with K/C/O mental retardation Attention - deficit Hyperactivity Disorder Autism Spectrum Disorders.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
On comparison, the efficacy of trial drug over control in improving Scholastic Performance of children of age group 11-16 years alongwith Cognition and Psychomotor domain.
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Title:AN IN-VITRO ACETYLCHOLINESTERASE INHIBITION ACTIVITY AND A DOUBLE BLIND PLACEBO CONTROLLED STUDY OF GUDUCHYADI YOGA ON SCHOLASTIC PERFORMANCE Trial Design: In Vitro and Clinical Study , Double Blind Placebo Controlled Study, Sample Size -100. Satisfying Inclusion-Exclusion Criteria JPIP Test of Scholastic Ability Academic Performance Rating Scale to access Teachers Judgement of Academic Performance Assent from child and Consent will be taken from Parents/Guardian/School Authority POSOLOGY DOSE: 6gm ANUPANA: Milk TIME : Twice a Day at Morn.7-8 am and Eve.4-5 pm DURATION : 60 Days
|