| CTRI Number |
CTRI/2025/02/081095 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
survey on Etiological factors in Early menarche |
|
Scientific Title of Study
|
A Study on Etiological factors in Early menarche - A Cross sectional study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Swati G Shirasangi |
| Designation |
student |
| Affiliation |
Poornima Ayurvedic Medical Colege Hospital and research centre |
| Address |
Poornima Ayurvedic Medical college Hospital and Research centre SY No 1163 MPL No 4 4 409 Mantralaya Road Raichur 584103 Karnataka
Raichur
KARNATAKA
584103
India |
| Phone |
8904676478 |
| Fax |
|
| Email |
swatishirasangi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soumya K |
| Designation |
Associate professor |
| Affiliation |
Poornima Ayurvedic Medical Colege Hospital and research centre |
| Address |
Poornima Ayurvedic Medical college Hospital and Research centre SY No 1163 MPL No 4 4 409 Mantralaya Road
Raichur
KARNATAKA
584103
India |
| Phone |
9620431144 |
| Fax |
|
| Email |
drsoumy.kosagi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soumya K |
| Designation |
Associate professor |
| Affiliation |
Poornima Ayurvedic Medical Colege Hospital and research centre |
| Address |
Poornima Ayurvedic Medical college Hospital and Research centre SY No 1163 MPL No 4 4 409 Mantralaya Road
Raichur
KARNATAKA
584103
India |
| Phone |
9620431144 |
| Fax |
|
| Email |
drsoumy.kosagi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Poornima Ayurvedic Medical College Hospital And Research Centre Raichur 584103 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Central council for Research in Ayurvedic Sciences |
| Address |
Ministry of AYUSH Govt of India
61-65 Institional Area Opp D Block Janakpuri New Delhi 110058 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Swati G Shirasangi |
Poornima Ayurvedic Medical College Hospital And Reseach centre |
Department of Roga Nidana Evam Vikruti Vigyana second floor Room 4 SY No 1163 MPL No 4 4 409 mantralaya road
opp to navodaya medical college RAaichur 584103 karnataka
Raichur
KARNATAKA |
8904676478
swatishirasangi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee of Poornima Ayurvedic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Study include only adolescent girls
Study include with age group of 10-15 year group
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Female |
| Details |
Study include only adolescent girls
Study include with age group of 10-15 year group
|
|
| ExclusionCriteria |
| Details |
Study exclude adolescent boys
Study exclude with age group of less than 10 year
Study exclude with age group of more than 15 years
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Casuses of Early Menarche |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Statistical Values About The Cause of Early Menarche |
2 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
05/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/03/2025 |
| 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
|
The clinical trial will be start after receiving CTRI registration. Healthy 250 Adolescent girls are selected for the study(randomly who have attained menarche) Enrolment and Consent will be received and Structured Questionnaire will be given to answer Collecting the information from females and Statistical analysis drawn on the bases of Questionnaire anwsered by female Adolescent. |