CTRI

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CTRI Number

CTRI/2023/05/052262 [Registered on: 03/05/2023] Trial Registered Prospectively

Last Modified On:

02/05/2023

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Study to evaluate the effect of Suvarnaprashan yoga on growth and development in Children

Scientific Title of Study

A Pre-clinical and clinical study to evaluate the effect of Suvarnaprashan yoga on growth and development in Children

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Minakshi
Designation	Reader,Department of kaumarbhritya
Affiliation	RGGPG Ayurvedic College and Hospital
Address	Room no-218,Anatomy block,RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal pradesh RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal pradesh Kangra HIMACHAL PRADESH 176115 India
Phone	9418017565
Fax
Email	drminakshi2050@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Minakshi
Designation	Reader,Department of kaumarbhritya
Affiliation	RGGPG Ayurvedic College and Hospital
Address	Room no-218,Anatomy block,RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal pradesh RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal pradesh Kangra HIMACHAL PRADESH 176115 India
Phone	9418017565
Fax
Email	drminakshi2050@gmail.com

Details of Contact Person
Public Query

Name	Dr Sahil Kumar
Designation	PG Scholar,Department of Kaumarbhritya
Affiliation	RGGPG Ayurvedic College and Hospital
Address	RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal pradesh RGGPG Ayurvedic College and Hospital,Paprola,Kangra,Himachal pradesh Kangra HIMACHAL PRADESH 176115 India
Phone	7018243015
Fax
Email	sahilkumardhiman@gmail.com

Source of Monetary or Material Support

Charak Govt. Ayurvedic Pharmacy Paprola, Distt. Kangra, Herbal garden and Herbarium, Research Institute in ISM, Jogindernagar, Distt. Mandi

Primary Sponsor

Name	RGGPG Ayurvedic College
Address	RGGPG Ayurvedic College and Hospital, Paprola, Kangra 176115
Type of Sponsor	Research institution and hospital

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 Minakshi	RGGPG Ayurvedic College, Paprola	Room no-218, Anatomy Block, RGGPG Ayurvedic College and Hospital, Paprola, Kangra, Himachal Pradesh. Kinnaur HIMACHAL PRADESH	9418017565 drminakshi2050@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics committee (Human)	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	To study the effect of Drug in growth and development in children

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Suvarnaprashan yoga , Reference: Sushruta Samhita, Sharir Sthana, 10/72,74, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 1(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
2	Comparator Arm	Drug	Other than Classical		(1) Medicine Name: Madhu & Ghrit , Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	1.00 Day(s)
Age To	2.00 Year(s)
Gender	Both
Details	1) Apparently Healthy children of age upto 2 years, irrespective of gender, religion, and socio-economic status etc. 2) Parents of study subjects willing to participate in the trial.

ExclusionCriteria

Details

1. Children above two years of age.
2. Children with any congenital disorder, syndrome etc.
3. Neonatal Anaemia, HIV and HbsAg + newborn.
4. Children with acute illness.
5. Children who are malnourished will be excluded.
6. Parents of the study subjects not willing to participate in the trial.

Method of Generating Random Sequence

Random Number Table

Method of Concealment

Alternation

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Fulfillment of objective and subjective criteria	90 days

Secondary Outcome

Outcome	TimePoints
To evaluate the safety of suvaranprashan yoga in children	90 days

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)

15/05/2023

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="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Not yet

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

I would like to publish my research trial after completion as soon as possible. A total of 100 subjects will be studied in 2 groups. 50 study subjects will be managed with Suvarnaprashan yoga and 50 study subjects will be managed with madhu and ghrita. The outcome will be analysed based on sujective and objective parameters with appropriate statistical tools.