| CTRI Number |
CTRI/2024/02/063142 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
23/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
awareness among college going girls on Polycystic ovarian disease. |
|
Scientific Title of Study
|
Cross-sectional study of college going girls on awareness of PCOD. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Isha Raman Srivastava |
| Designation |
Student |
| Affiliation |
Guru Gorakshnath institute of Medical sciences |
| Address |
Dept. of Samhita And Siddhanth , Romm No.37, Guru Gorakshnath institute of medical sciences (Faculty of Ayurveda) , Arogya dham , Sonbarsa , Balapar road , Gorakhpur , Utter Pradesh
Gorakhpur
UTTAR PRADESH
273007
India |
| Phone |
8081907626 |
| Fax |
|
| Email |
ay01220039@mgug.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Pragya Singh |
| Designation |
Assistant Professor |
| Affiliation |
Guru Gorakshnath institute of Medical sciences |
| Address |
Depart of Samhita and Siddhanth, Room No. 37, Guru Gorakshnath institute of medical sciences (Faculty of Ayurveda) , Arogya dham , Sonbarsa , Balapar road , Gorakhpur , Utter Pradesh
Gorakhpur
UTTAR PRADESH
273007
India |
| Phone |
8858850635 |
| Fax |
|
| Email |
drpragya@mgug.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Pragya Singh |
| Designation |
Assistant Professor |
| Affiliation |
Guru Gorakshnath institute of Medical sciences |
| Address |
Dept. of Samhita and Siddhant, Room No. 37, Guru Gorakshnath Institute of medical sciences (Faculty of Ayurveda), Arogya dham , Sonbarsa , Balapar road , Gorakhpur , Utter Pradesh
Gorakhpur
UTTAR PRADESH
273007
India |
| Phone |
8858850635 |
| Fax |
|
| Email |
drpragya@mgug.ac.in |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan No.61-65, Institutional Area , Opp. DBlock , Jankipuri , New Delhi-110058 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pragya Singh |
Guru Gorakshnath Institute of Medical Sciences Faculty of Ayurveda |
Department of Samhita & Siddhanta , Arogya Dham , Balapar , Sonbarsa Gorakhpur , 273007
Gorakhpur
UTTAR PRADESH |
8858850635
drpragya@mgug.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commmittee for Human Studies, Guru Gorakshnath Institute of Medical Sciences, Arog yadham,Sonbarsa,Bala par Road,Gorakhpur 273007 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
observational study on college going girls who have already attains menarche |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1) college going girls (18 to 25 years of age )
2) urban and rural area colleges
3) giving voluntary consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1) not willing to give consent
2) not fulfilling inclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence and awareness of PCOD in college going girls. |
Baseline of prevalence awareness on food by pre and post test after giving 30 min. class |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
05/03/2024 |
| 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
|
Cross-sectional study of college going girls on awareness of PCOD. Polycystic ovarian disorder is a complex genetic disorder between 2.2 and 26.7% of girls in certain age group have PCOD. It is recognized as an important reproductive as well as a metabolic disorder since it affects the ovaries. In earlier days it was known because of small cystic ovary, but now there could be various cause for it. In Ayurvedic classics there is no direct mentioning of this disease rather,symptoms are found under various diseased conditions at various references i.e.,Aartavavaha strotas dushti, Nastaartava, Granthi, Santarponnth vyadhi,Yonivyapad. My objective is to assess the prevalence and knowledge of PCOD among adolescents and young girls And To find the differences the awareness of college going girls on PCOD among rural and urban. Sample no- Total 200, urban 100 and rural 100.Design - Investigator will visit the college and take the permission from college Dean/Principal for conducting the cross-sectional study in the college, Participants will be informed about the study , those who are willing to give voluntary informed consent to participate in the study. The data will be collected in the form of pre-validated questionnaires designated as pre and post-test questionnaires. Thirty-minute chalk and board teaching methodology will be used along with some charts of the reproductive system to explain the keynotes and provide information regarding PCOD. All the study participants actively participated in the session, which will be interactive, wherein questions and doubts raised by the participants are addressed.The data collected will be systematically entered into a Microsoft Office 2019 Excel sheet (Microsoft® Corp, Redmond, WA), and tables will be prepared to calculate the mean and percentage. The data collected will be processed using statistical software SPSS 11.0 (IBM Corp., Armonk, NY), and the chi-square test will be used to find out the significance of the output obtained.
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