| CTRI Number |
CTRI/2025/08/093111 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on What School Girls in Itanagar Know, Feel, and Do About Menstruation |
|
Scientific Title of Study
|
A Cross-sectional Study on Knowledge, Attitudes, and Practices (KAP) related to Menstruation among School-going Adolescent Girls in Itanagar, Papum Pare |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arvind Kumar |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute, Itanagar |
| Address |
Room No. 13, Ground Floor, Regional Ayurveda Research Institute, Near Mithun Gate, Itanagar
Papum Pare
ARUNACHAL PRADESH
791111
India |
| Phone |
9660033435 |
| Fax |
|
| Email |
dr.arvindaggarwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arvind Kumar |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute, Itanagar |
| Address |
Room No.13, Ground Floor, Regional Ayurveda Research Institute, Near Mithun Gate, Itanagar
Papum Pare
ARUNACHAL PRADESH
791111
India |
| Phone |
9660033435 |
| Fax |
|
| Email |
dr.arvindaggarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arvind Kumar |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Regional Ayurveda Research Institute, Itanagar |
| Address |
Room No.13, Ground Floor, Regional Ayurveda Research Institute, Near Mithun Gate, Itanagar
Papum Pare
ARUNACHAL PRADESH
791111
India |
| Phone |
9660033435 |
| Fax |
|
| Email |
dr.arvindaggarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences (Under Ministry of Ayush, Government of India), 61-65, Opposite D-Block, Janakpuri Institutional Area, New Delhi-110058 |
|
|
Primary Sponsor
|
| Name |
Regional Ayurveda Research Institute |
| Address |
Near Mithun Gate, Itanagar-791111, Arunachal Pradesh |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arvind Kumar |
Mallo Tarin Higher Secondary School |
Near Education Office, Itanagar
Papum Pare
ARUNACHAL PRADESH |
9660033435
dr.arvindaggarwal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC RARI ITANAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Menstruating Adolescent Female |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Female |
| Details |
1. Girls who are willing to participate and provide informed written consent & assent.
2. Girls from 14 to 17 years of age.
3. Girls enrolled in the selected schools. |
|
| ExclusionCriteria |
| Details |
1. Girls who had not attained menarche. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the Knowledge, Attitude and Practices related to menstruation among school-going adolescent girls. |
At the time of data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the association of Knowledge, Attitude and Practices related to menstruation among school-going adolescent girls with the education of their mothers. |
At the time of data collection |
| To determine the association of Knowledge, Attitude and Practices related to menstruation among school-going adolescent girls with the occupation of their mothers. |
At the time of data collection |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/09/2025 |
| 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="0"
Months="3"
Days="8" |
|
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
|
This observational cross-sectional study aims to assess the knowledge, attitudes, and practices related to menstruation among school-going adolescent girls (aged 14–17 years) in Itanagar, Papum Pare, Arunachal Pradesh. The study will be conducted in randomly selected high/senior secondary schools near the Regional Ayurveda Research Institute. Data will be collected using a structured questionnaire covering various aspects of menstrual health and hygiene. The study also aims to investigate the relationship between KAP and the education and occupation of the participants’ mothers. The findings will help identify gaps in menstrual health awareness and inform future health education strategies. |