| CTRI Number |
CTRI/2025/04/085457 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE STUDY ON THE EFFICACY OF YASHTIMADHU GRANULES AND YASHTIMADHU CHURNA IN ENHANCING IQ IN ADOLESCENT |
|
Scientific Title of Study
|
Comparative study on the efficacy of Yashtimadhu Granules and Yashtimadhu Churna in enhancing IQ in adolescents |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Dinesh Chandra Sharma |
| Designation |
Professor |
| Affiliation |
PGIA Jodhpur |
| Address |
Room no 143, PG Department of Kriya Sharir, PGIA, DSRRAU, Jodhpur 342037
Nagaur Road Karwad Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7014706160 |
| Fax |
|
| Email |
dr_dcsharma@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Dinesh Chandra Sharma |
| Designation |
Professor |
| Affiliation |
PGIA Jodhpur |
| Address |
Room no 143, PG Department of Kriya Sharir, PGIA, DSRRAU, Jodhpur 342037
Nagaur Road Karwad Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7014706160 |
| Fax |
|
| Email |
dr_dcsharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Dinesh Chandra Sharma |
| Designation |
Professor |
| Affiliation |
PGIA Jodhpur |
| Address |
Room no 143, PG Department of Kriya Sharir, PGIA, DSRRAU, Jodhpur 342037
Nagaur Road Karwad Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7014706160 |
| Fax |
|
| Email |
dr_dcsharma@yahoo.com |
|
|
Source of Monetary or Material Support
|
| PGIA, DSRRAU, Jodhpur
dist - rajashtan, india
pin 342037 |
|
|
Primary Sponsor
|
| Name |
PGIA DSRRAU Jodhpur |
| Address |
Nagaur Road Kadwad Jodhpur,
rajasthan ,india
pin code 342037 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shubham Attarkar |
HOSPITAL PGIA DSRRAU JODHPUR |
Nagaur road Kadwad Jodhpur,rajasthan ,india, pin code 342037
Jodhpur
RAJASTHAN |
8605131642
mr.shubhamattarkar97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
APPARENTLY HEALTHY VOLUNTEERS |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: yashtimadhu churna, Reference: charak chikitsa sthan chapter no 1 shlok no 30 and 31, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: luke warm milk), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: yashtimadhu granules, Reference: charak chikitsa sthan chapter 1 shlok no 30 and 31, Route: Oral, Dosage Form: Khanda /Granules, Dose: 05(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: luke warm milk), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy subjects between age group of 16 yrs to 20 yrs with IQ score ranging 80-109 (scores obtained after conducting verbal & performance sub-tests) will be included irrespective of their sex & socio-economic status. |
|
| ExclusionCriteria |
| Details |
Subjects below 16 years & above 20 years of age.
Subjects suffering from any systemic disorders.
Subjects with learning disorders & any genetic disorder.
Subjects with history of hypersensitivity to any of the trial drug and its ingredients.
Subjects who are not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Yashtimadhu (SAT-F.484) Granules & Yashtimadhu (SAT-F.484) Churna to boost intelligence in adolescents. |
IN 45 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To enhance intelligent quotient in subjects.
To study the concept of Medha (SAT-D.6344). |
IN 45 DAYS |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="1"
Days="15" |
|
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
|
This summary is for a clinical trial comparing Yashtimadhu granules and churna to enhance IQ in school-going children aged 16–20.
The study involves 150 participants, randomized into two groups with different doses.
Research suggests it’s an open-label, 45-day study with assessments every 15 days.
The evidence leans toward measuring IQ with the Wechsler Adult Intelligence Scale (WAIS). |