CTRI

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CTRI Number

CTRI/2025/02/080697 [Registered on: 17/02/2025] Trial Registered Prospectively

Last Modified On:

07/02/2025

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 Vijaya ghrita over Brahmi ghrita in Specific Learning Disability in children

Scientific Title of Study

Efficacy of Vijaya Ghrita in Comparison to Brahmi Ghrita on Specific Learning Disability in 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 Soumya S
Designation	Post Graduate Scholar
Affiliation	Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru
Address	Department of Kaumarabhritya, OPD No. 7,8,9,23 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17, Anchepalya, Kumbalgodu Post, Challegatta, Bengaluru- 560074 Bangalore KARNATAKA 560074 India
Phone	9535717745
Fax
Email	soumyas0796@gmail.com

Details of Contact Person
Scientific Query

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

Details of Contact Person
Public Query

Name	Dr Soumya S
Designation	Post Graduate Scholar
Affiliation	Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru
Address	Department of Kaumarabhritya, OPD No. 7,8,9,23 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17, Anchepalya, Kumbalgodu Post, Challegatta, Bengaluru- 560074 Bangalore KARNATAKA 560074 India
Phone	9535717745
Fax
Email	soumyas0796@gmail.com

Source of Monetary or Material Support

Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17, Anchepalya, Kumbalgodu Post, Challegatta, Bengaluru- 560074

Primary Sponsor

Name	Dr Soumya S
Address	Department of Kaumarabhritya, OPD No. 7,8,9,23 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17, Anchepalya, Kumbalgodu 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 Soumya S	Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru	Department of Kaumarabhritya, OPD No. 7,8,9,23 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17, Anchepalya, Kumbalgodu Post, Challegatta, Bengaluru- 560074, Karnataka, India Bangalore KARNATAKA	9535717745 soumyas0796@gmail.com

Details of Ethics Committee

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

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:F819\|\|Developmental disorder of scholastic skills, unspecified. Ayurveda Condition: MANOVAHASROTODUSHTIH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: Brahmi ghrita, Reference: Ashtanga hrudaya, Uttarasthana, 6/23-24, Route: Oral, Dosage Form: Ghrita, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Hot water), Additional Information: -For children aged 8 to 11 years- 6g in two divided doses i.e 3g BD with hot water before food. -For children aged 12 to 15 years- 10g in two divided doses i.e 5g BD with hot water before food.
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Vijaya ghrita, Reference: Basavarajeeyam, Vimsham prakaranam, Unmada- apasmaradinam vijaya ghritam, 77-80, Route: Oral, Dosage Form: Ghrita, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Hot water), Additional Information: -For children aged 8 to 11 years- 6g in two divided doses i.e 3g BD with hot water before food. -For children aged 12 to 15 years- 10g in two divided doses i.e 5g BD with hot water before food.

Inclusion Criteria

Age From	8.00 Year(s)
Age To	15.00 Year(s)
Gender	Both
Details	Children with Specific Learning Disability belonging to the age group of 8 to 15 years with Intellectual quotient greater than 90, after getting consent from their parents.

ExclusionCriteria

Details

Children having speech and hearing defects
Children having seizures
Children having other systemic illness
Children having mental retardation
Children with Intellectual Quotient less than 90
Children with Autism and ADHD
Children with emotional and conduct disorder

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Improvement in reading, writing and mathematical abilities in children suffering with Specific learning disability using NIMHANS SLD battery.	60 days

Secondary Outcome

Outcome	TimePoints
Improvement in overall school performance of children suffering from Specific Learning Disability using NIMHANS SLD battery.	60 days

Target Sample Size

Total Sample Size="32"
Sample Size from India="32"
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 2/ Phase 3

Date of First Enrollment (India)

01/03/2025

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

Recruitment Status of Trial (Global)

Open to Recruitment

Recruitment Status of Trial (India)

Open to Recruitment

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

TITLE: EFFICACY OF VIJAYA GHRITA IN COMPARISON TO BRAHMI GHRITA ON SPECIFIC LEARNING DISABILITY IN CHILDREN- AN OPEN LABELLED RANDOMIZED CONTROLLED CLINICAL TRIAL.

PLAN OF STUDY: Minimum 32 children attending outpatient department and inpatient department of Kaumarabhritya of Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital (SDMIAH), Bengaluru who are fulfilling the inclusion criteria and willing to participate in the study under the parental assent or consent will be recruited for study for a period of 60 days. 32 children will be randomly divided into 2 groups namely Group A(16 children) and Group B (16 children). Group A (Study group) will be administered with Vijaya ghrita in a dose of 6g for 8-11 years and 10g for 12-15 years with hot water as anupana after food twice daily. Group B (Control group) will be administered with Brahmi ghrita in a dose of 6g for 8-11 years and 10g for 12-15 years with hot water as anupana after food twice daily. Assessment will be done using NIMHANS SLD battery by Clinical Psychologist. Statistical analysis will be done by considering the data of 0 (BT) and day 60 (AT) by using suitable test.