CTRI

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CTRI Number

CTRI/2025/02/080259 [Registered on: 10/02/2025] Trial Registered Prospectively

Last Modified On:

04/02/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A comparison of Vruddhadharuka Rasayana choorna over Shatapushpa Choorna to enhance Intelligence in school children

Scientific Title of Study

Efficacy of Vruddhadharuka Rasayana in Comparision to Shatapushpa Choorna on Enhancement of Intelligence Quotient in School Children - An Open Labelled Randomized Controlled Clinical Trial

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 Nisarga S
Designation	PG Scholar
Affiliation	Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru
Address	Department of Kaumarabhritya, OPD no.7,8,9,23 Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17, Anchepalya, Kumbalagodu post, Challegatta, Bengaluru - 560074 Bangalore KARNATAKA 560074 India
Phone	9844823641
Fax
Email	nisarga2411niss@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Girish Kumar SV
Designation	Associate Professor
Affiliation	Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru
Address	Department of Kaumarabhritya, OPD no.7,8,9,23 Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17, Anchepalya, Kumbalagodu post, Challegatta, Bengaluru - 560074 Bangalore KARNATAKA 560074 India
Phone	9449577136
Fax
Email	drgirishkumargowda@gmail.com

Details of Contact Person
Public Query

Name	Dr Nisarga S
Designation	PG Scholar
Affiliation	Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru
Address	Department of Kaumarabhritya, OPD no.7,8,9,23 Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17, Anchepalya, Kumbalagodu post, Challegatta, Bengaluru - 560074 Bangalore KARNATAKA 560074 India
Phone	9844823641
Fax
Email	nisarga2411niss@gmail.com

Source of Monetary or Material Support

Department of Kaumarabhritya OPD No. 7,8,9,23 Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17, Anchepalya, Challegatta, Bengaluru 560074, Karnataka, India

Primary Sponsor

Name	Dr Nisarga S
Address	Department of Kaumarabhritya, OPD no.7,8,9,23 Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17, Anchepalya, Kumbalagodu post, Challegatta, Bengaluru - 560074
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Nisarga S	Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru	Department of Kaumarabhritya, OPD no.7,8,9,23 Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17, Anchepalya, Kumbalagodu post, Challegatta, Bengaluru - 560074, Karnataka, India Bangalore KARNATAKA	9844823641 nisarga2411niss@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy school children of Intelligence Quotient ranging from 70 to 109 (score obtained after conducting verbal and performance subtests - based upon Malin’s Intelligence Scale for Indian Children)

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: Shatapushpa Choorna, Reference: Kashyapa Samhita, Kalpa sthana, 5th chapter, Shatavari Shatapushpa Adhyaya, 17th to 18th shloka, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ghrita and Madhu), Additional Information: -
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Vruddhadharuka Rasayana, Reference: Bhaishajya Ratnavali, Rasayana Prakarana, 73rd chapter, 13th shloka , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ghrita and Madhu), Additional Information: -

Inclusion Criteria

Age From	10.00 Year(s)
Age To	16.00 Year(s)
Gender	Both
Details	1. School children of age group 10 to 16 years irrespective of sex, caste, religion, socio economic status with IQ score ranging 70 to 109, which is Borderline IQ 70 to 79, Low Average IQ 80 to 89, Average IQ 90 to 109, Scores obtained after conducting verbal and performance subtests based upon Malin’s Intelligence Scale for Indian Children, Willing and able to participate and ready to sign consent form.

ExclusionCriteria

Details

1. Children of age below 10 years and above 16 years.

2. Children having Intelligence quotient level less than 70 and more than 109, Scores obtained after conducting verbal and performance subtests based upon Malin’s Intelligence Scale for Indian Children.

3. Children with neurobehavioral disorders like ADHD, Autism, Intellectual disability, psychiatric illness, personality disorders, congenital abnormalities, genetic disorders.

4. Children suffering from any chronic illness, systemic disorders and on treatment, which may turn out to be hindrance in the study.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Improvement in Intelligence quotient based upon – “MALIN’S INTELLIGENCE SCALE FOR INDIAN CHILDREN” [MISIC] Improvement in Functional aspect of Buddhi Based upon – “BUDDHI ASSESSMENT SCALE”	30 days

Secondary Outcome

Outcome

TimePoints

To evaluate the efficacy of Vruddhadharuka Rasayana in improving the quality of life in School children based upon – “WHO QUALITY OF LIFE INDEX.

To compare the efficacy of Vruddhadharuka Rasayana and Shatapushpa choorna –
On enhancement of Intelligence quotient based on - Malin’s intelligence scale for Indian children
Functional aspects of Buddhi based on - Buddhi assessment scale
Quality of life based on - WHO Quality of life parameters

30 days

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30"

Phase of Trial

Phase 2/ Phase 3

Date of First Enrollment (India)

27/02/2025

Date of Study Completion (India)

24/02/2026

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Completed

Recruitment Status of Trial (India)

Completed

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 controlled clinical trial on the efficacy of Vruddhadharuka Rasayana in comparision to Shatapushpa Choorna on enhancement of Intelligence Quotient in school children aged 10 to 16 years.

A minimum of 30 School children aged 10 to 16 years will be screened for IQ score ranging 70–109 [Borderline IQ -70 to 79, Low Average-80 to 89, Average-90 to 109; Scores obtained after conducting verbal and performance subtests - based upon Malin’s Intelligence Scale for Indian Children], followed by recruitment under parental consent for a period of 30 days.

During the study period the school children will be divided into two groups, Group A (trial drug) and Group B (control drug) with 15 children in each group, Group A children will receive Vruddhadharuka Rasayana and Group B children will receive Shatapushpa Choorna in a dose of 6 grams, morning and night, before food with Ghrita and Madhu as Anupana for about 30 days.

Clinical assessment will be done on 0th and 30th day for both subjective and objective criteria using Malin’s Intelligence Scale for Indian Children (MISIC), Buddhi assessment scale and WHO Quality of life index and statistical analysis will be done by considering the data obtained on 0th and 30th day.