CTRI

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CTRI Number

CTRI/2024/02/062848 [Registered on: 19/02/2024] Trial Registered Prospectively

Last Modified On:

17/02/2024

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Assessment of Menstrual hygiene practices among School girls

Scientific Title of Study

Assessment of knowledge and Practices of Menstrual Hygiene among High school girls of Government and Non-government

Trial Acronym

Clinical Trial

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Sachin chintamani
Designation	3RD PROFESSIONAL BAMS STUDENT
Affiliation	Shri Vijay Mahantesh Ayurvedic Medical College and PG Research Centre Ilkal 587-125
Address	Shri Vijay Mahantesh Ayurvedic Medical College and PG Research Centre Ilkal,Department of Swasthavritta and Yoga 587-125 Tq:Hungund Dis: Bagalkote Shri Vijay Mahantesh Ayurvedic Medical College and PG Research Centre Ilkal,Department of Swasthavritta and Yoga 587-125 Tq:Hungund Dis: Bagalkote Bagalkot KARNATAKA 587125 India
Phone	7204153436
Fax
Email	sachinchintamani632@gmail.com

Details of Contact Person
Scientific Query

Name	Sachin chintamani
Designation	3RD PROFESSIONAL BAMS STUDENT
Affiliation	Shri Vijay Mahantesh Ayurvedic Medical College and PG Research Centre Ilkal
Address	Shri Vijay Mahantesh Ayurvedic Medical College and PG Research Centre Ilkal,Department of Swasthavritta and Yoga 587-125 Tq:Hungund Dis: Bagalkote Shri Vijay Mahantesh Ayurvedic Medical College and PG Research Centre Ilkal,Department of Swasthavritta and Yoga 587-125 Tq:Hungund Dis: Bagalkote Bagalkot KARNATAKA 587125 India
Phone	7204153436
Fax
Email	sachinchintamani632@gmail.com

Details of Contact Person
Public Query

Name	Sachin chintamani
Designation	3RD PROFESSIONAL BAMS STUDENT
Affiliation	Shri Vijay Mahantesh Ayurvedic Medical College and PG Research Centre Ilkal
Address	Shri Vijay Mahantesh Ayurvedic Medical College and PG Research Centre Ilkal,Department of Swasthavritta and Yoga 587-125 Tq:Hungund Dis: Bagalkote Shri Vijay Mahantesh Ayurvedic Medical College and PG Research Centre Ilkal,Department of Swasthavritta and Yoga 587-125 Tq:Hungund Dis: Bagalkote Bagalkot KARNATAKA 587125 India
Phone	7204153436
Fax
Email	sachinchintamani632@gmail.com

Source of Monetary or Material Support

Shri Vijay Mahantesh Ayurvedic Medical College Ilkal

Primary Sponsor

Name	Shri Vijaya Mahantesh Ayurvedic Medical College and PG Research centre Ilkal
Address	TQ:HUNGUND DIST:BAGALAKOTE,KARNATAKA PIN:587-125
Type of Sponsor	Private medical college

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
Sachin Chintamani	1.S R KANTHI GIRLS HIGH SCHOOL IKLAL 2.GOVERNMENT GIRLS HIGH SCHOOL ILKAL	Shri Vijaya Mahantesh Ayurvedic Medical College and PG Research Centre Ilkal 587-125 Bagalkot KARNATAKA	7204153436 sachinchintamani632@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICAL COMMITTE Shri Vijay Mahantesh AYURVEDIC MEDICAL COLLEGE ILKAL	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy girls without any systemic disorders.

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Lifestyle	-	-	Dinacarya: , Ritucarya: , Acara Rasayana:, Other:HYGIENE, Pathya/Apathya:no, Pathya:, Apathya:

Inclusion Criteria

Age From	14.00 Year(s)
Age To	16.00 Year(s)
Gender	Female
Details	1.High school girls having age between 14-16 years from government high school. 2.High school girls having age between 14-16 years from non-government high school. 3.Healthy girls without any systemic disorders.

ExclusionCriteria

Details

1.School girls below 14 years and above 16 years.
2.High school girls those who were not willing to participate in this study.
3.High school girls with any other physical and mental illness.

Method of Generating Random Sequence

Random Number Table

Method of Concealment

An Open list of random numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1.It will help to improve the menstrual hygiene for the girls with education. 2.Large scale implementation for the menstrual hygiene will make the social health development.	60 days

Secondary Outcome

Outcome	TimePoints
1.Implementation of unhygienic condition to hygienic lifestyle of women.	90 days

Target Sample Size

Total Sample Size="240"
Sample Size from India="240"
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

N/A

Date of First Enrollment (India)

29/02/2024

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="2"
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

To maintain the hygiene of girls aged between 14 to 16 years and who attained menarche selected for the present study.We have randomly selected 120 girls from Government High school and 120 girls from Non-government high school to assess the knoweldge and practices of menstrual hygiene for healthy living.Predesigned menstrual practice questionnaires were used and we need 60 days duration for this study.