| CTRI Number |
CTRI/2025/09/094866 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [Intelligence Quotient in Adolescent] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Improving I.Q. (Intelligence Quotient) in Adolescents with Medhya Rasayana: Results from a Double Blind Clinical Trial. |
|
Scientific Title of Study
|
A Randomized Double-Blind Placebo-Controlled study on Adolescent school going Children’s Intelligence with Medhya Rasayan. |
| 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 Neha Kumawat |
| Designation |
Assistant Professor, Ph.D. Scholar |
| Affiliation |
R.B. Ayurved Medical College & Hospital, Agra |
| Address |
Room no-3, Kaumarbhritya Department, R.B. Ayurved Medical college & Hospital, Jalesar Road, Mudi Chauraha, Agra
Agra UTTAR PRADESH 283126 India |
| Phone |
7665980352 |
| Fax |
|
| Email |
drnehakumawat94@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Neha Kumawat |
| Designation |
Assistant Professor, Ph.D. Scholar |
| Affiliation |
R.B. Ayurved Medical College & Hospital, Agra |
| Address |
Room no-3, Kaumarbhritya Department, R.B. Ayurved Medical college & Hospital, Jalesar Road, Mudi Chauraha, Agra
Agra UTTAR PRADESH 283126 India |
| Phone |
7665980352 |
| Fax |
|
| Email |
drnehakumawat94@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Suhas A Chaudhary |
| Designation |
Research officer (Ayurveda) |
| Affiliation |
M.S. Regional Ayurveda Research Institute (MSRARI) , Jaipur, Rajasthan |
| Address |
Room No 11 B, First floor, M.S. Regional Ayurveda Research Institute (MSRARI),Indira Colony, Jhotwara road, Banipark, Jaipur
Under Central Council for Research in Ayurveda Sciences (CCRAS), Ministry of AYUSH, Govt. of India, Jaipur RAJASTHAN 302016 India |
| Phone |
9427073351 |
| Fax |
|
| Email |
vdsuhaschaudhary@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
M.S. Regional Ayurveda Research Institute (MSRARI) ,Jaipur |
| Address |
M.S. Regional Ayurveda Research Institute (MSRARI), Central Council for Research in Ayurveda Sciences (CCRAS), Ministry of AYUSH, Govt. of India, Indira Colony, Jhotwara Road, Bani Park, Jaipur, Rajasthan
Pin code- 302016 |
| 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 Neha Kumawat |
R.B. Ayurvedic Medical college and Hospital, Schools of Agra |
Room No-3, Balrog OPD, R.B. Ayurvedic Medical College and Hospital, Jalesar Road, Mudi Chauraha, Agra Agra UTTAR PRADESH |
7665980352
drnehakumawat94@mail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of MS Regional Ayurveda Research Institute Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal healthy children age group between 10 -15 years having Average I.Q. (89-109) will be selected for clinical trial through Malin’s Intelligence Scale for Indian Children (MISIC). |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Medhya Rasayan, Reference: Charak Smhita, Chikitsasthan; Rasayana Adhyaya, Tritiya pad, Shloka no- 30-31, Route: Oral, Dosage Form: Sattva, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: -Using Hydro-alcoholic extract of Medhya Rasayan drugs { Mandukaparni (Centella asiatica Linn.), Yastimadhu (Glycirrhiza glabra Linn.), Guduchi (Tinospora cordifolia) and Shankhpushpi (Convolvulus pleuricaulis Chois)} | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | Drug- Placebo capsule filled with wheat flour (Identical in appearance to the intervention capsules to maintain the blinding of the study)
Dosage form- 250 mg in each capsule
Dose- 1 capsule O.D.
Route of administration- Orally
Time of administration- After food
Anupana- Lukewarm water |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Adolescent age group children i.e. 10 to 15 years of either sex.
2. Children with average IQ 89 to 109 with Malins scale.
3. Assent and consent both should be provided by parents/guardians and child.
4. Patient should be capable of obeying the instruction related to course of therapy.
5. Willingness to follow the treatment regimen and attend follow up sessions. |
|
| ExclusionCriteria |
| Details |
1. Children with diagnosed neurological disorders (e.g., ADHD, ASD etc.).
2. I.Q. below 89 and above 109.
3. Use of psychotropic medications during the study.
Known allergies to trial drugs or ingredients.
4. Patient/Attendant not willing to give written consent for participation in the research study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome-
Changes in IQ: - To evaluate the effects of the Medhya Rasayan extract capsule on the intelligence of children (IQ) through MISIC. |
(Baseline and End of 90th Day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Ayurvedic Parameters: - To evaluate the effects of the Medhya Rasayan extract capsule on the Ayurvedic Parameters i.e. Medha, Smiriti, Dhriti, Vigyana. |
(Baseline, 15th day, 30th day, 45th day, 60th day, 75th day and 90th Day) |
| To evaluate the safety of drug through laboratory investigations. |
(Baseline and End of 90th Day) |
|
|
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)
|
29/09/2025 |
| 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="2" Months="0" Days="0" |
|
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
|
A Randomized Double-Blind Placebo-Controlled Study on Adolescent School-Going Children’s Intelligence with Medhya Rasayan This Ph.D. research by Dr. Neha Kumawat under the guidance of Dr. Suhas A. Chaudhary at CCRAS Jaipur aims to evaluate the role of Medhya Rasayan in enhancing intelligence among adolescents. Academic pressure during the age of 10–15 years often affects memory, attention, and problem-solving skills. While synthetic IQ boosters are widely available, their safety and efficacy remain questionable. Ayurveda mentions Medhya Rasayan like Shankhapushpi, Yashtimadhu, Guduchi, and Mandukaparni as natural cognitive enhancers, but scientific validation is limited. A total of 100 children with average IQ will be enrolled in a randomized, double-blind, placebo-controlled trial for 120 days. Participants will be divided equally into Medhya Rasayan and placebo groups, with assessments using MISIC and Ayurvedic parameters of Buddhi. Safety will be ensured through haematological and biochemical tests. The study expects significant improvement in IQ and cognitive abilities in the treatment group, thereby providing scientific evidence for the efficacy and safety of Medhya Rasayan in adolescent children. This research intends to bridge traditional Ayurvedic wisdom with modern scientific validation for cognitive enhancement. |