CTRI

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CTRI Number

CTRI/2026/02/104886 [Registered on: 26/02/2026] Trial Registered Prospectively

Last Modified On:

25/02/2026

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Menstrual Practices among Women of the Kadugolla Community in Tumkur District, Karnataka

Scientific Title of Study

Socio-Cultural Practices Related to Menstruation among the Kadugolla Community in Tumkur District -An Explanatory Study

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 Navyashree N
Designation	Student
Affiliation	Nitte Institute of Allied Health Sciences,
Address	Department of Public Health, Master of Public Health Programme, Physiotheraphy block Nitte Institute of Allied Health Sciences, Deralakatte, Mangaluru – 575 018, Karnataka, India. Nitte Institute of Allied Health Sciences, Deralakatte, Mangaluru - 575 018 Dakshina Kannada KARNATAKA 575018 India
Phone	9108939617
Fax
Email	drshreenavya@gmail.com

Details of Contact Person
Scientific Query

Name	Mr. Prajwal Jupiter Lobo
Designation	Assistant Professor
Affiliation	Nitte Institute of Allied Health Sciences,
Address	Department of Public Health Institution: Nitte Institute of Allied Health Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru – 575 018, Karnataka, India Nitte Institute of Allied Health Sciences, Deralakatte, Mangaluru - 575 018 Dakshina Kannada KARNATAKA 575018 India
Phone	8828224857
Fax
Email	prajwal.lobo@nitte.edu.in

Details of Contact Person
Public Query

Name	Dr Navyashree N
Designation	Student
Affiliation	Nitte Institute of Allied Health Sciences,
Address	Department of Public Health, Master of Public Health, Nitte Institute of Allied Health Sciences, Physiotherapy Block, Deralakatte, Doddagollarahatti nagadevanahalli jnanabharathi post Bangalore KARNATAKA 575018 India
Phone	9108939617
Fax
Email	drshreenavya@gmail.com

Source of Monetary or Material Support

Self funded

Primary Sponsor

Name	Self-funded
Address
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
Dr Navyashree N	Selected village in Sira taluk, Tumkur district	Tumkur district ,Sira taluk, Karnataka, India Tumkur KARNATAKA	09108939617 drshreenavya@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
K.S.HEGDE MEDICAL ACADEMY	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Menstrual practices and socio cultural factors related to menstruation

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	49.00 Year(s)
Gender	Female
Details	1. Women aged 18 to 49 years belonging to the Kadugolla community and residing in the selected clusters of Sira Taluk 2. Women who are currently menstruating or have had at least one menstrual cycle within the past six months. 3. Participants who are able to provide informed consent and are willing to participate in the study.

ExclusionCriteria

Details

1.Women with cognitive or psychiatric conditions that impair their ability to communicate or participate.
2.Women with amenorrhea in the past six months due to physiological or medical conditions (e.g., pregnancy, lactation, menopause, hormonal disorders).
3.Temporary residents or those who have lived in the community for less than one year.
4.Women who withdraw from the study at any stage of participation

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Proportion of women practicing specific menstrual hygiene practices Proportion of women following menstrual seclusion practices during menstruation	Baseline (at the time of participant enrollment/interview).

Secondary Outcome

Outcome	TimePoints
Socio-cultural beliefs & social norms influencing menstrual practices Factors associated with menstrual hygiene & seclusion practices	Baseline (at the time of participant enrollment or interview).

Target Sample Size

Total Sample Size="854"
Sample Size from India="854"
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)

17/03/2026

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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 is a community based explanatory study conducted among women aged 18 years and above belonging to the Kadugolla community in Tumkur district Karnataka India. The study aims to document menstrual practices and to explore socio cultural beliefs and social norms influencing menstruation. A descriptive cross sectional design will be used for quantitative data collection followed by in depth interviews for qualitative exploration. Data will be collected using a structured questionnaire and an in depth interview guide. The findings of the study will help in understanding culturally rooted menstrual practices and support the development of context specific public health interventions.