| CTRI Number |
CTRI/2025/09/095342 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational study for prevalence of Artavvriddhi and artavakshaya in female of reproductive age in Akola inview to create awareness about Ayurvedic regimens |
|
Scientific Title of Study
|
Observational study to assess the prevalence of aartavavriddhi and aartavakshaya in female of Reproductive age in Akola city in view to create awareness |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manisha Deokate |
| Designation |
PhD Scholar |
| Affiliation |
D.Y.PATIL UNIVERCITY PIMPARI |
| Address |
Department of prasutitantra and Strirog, D.Y.Patil Ayurved college and Research centre, Pimpari, Pune
Dr.Smritika Taware
Professor,H.O.D. Prasuti- Streerog
D.Y.Patil ayu. college and Reasearch center, Pimpari, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
09011493626 |
| Fax |
|
| Email |
manisha.deokate1362@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Smritika Taware |
| Designation |
Professor and Head of The Department |
| Affiliation |
D.Y.PATIL UNIVERSITY PIMPARI |
| Address |
Department of Prasutitantra - Strirog, D.Y.Patil Ayurved college and Research centre, Pimpari, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9850967065 |
| Fax |
|
| Email |
smritika.taware@ dpu.in |
|
Details of Contact Person
Public Query
|
| Name |
Manisha Deokate |
| Designation |
PhD Scholar |
| Affiliation |
D.Y.PATIL UNIVERCITY PIMPARI |
| Address |
D.Y.Patil Ayurved college and Research centre, Pimpari, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
09011493626 |
| Fax |
|
| Email |
manisha.deokate1362@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.Y.Patil Ayurved College and Research Center,Pimpari, PUNE,Maharashtra |
|
|
Primary Sponsor
|
| Name |
DYPatil Ayurved College and Research Center |
| Address |
D.Y.Patil University ,Pimpari, Pune 411018 |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Manisha Deokate |
D.Y. Patil ayurved college and hospital, Pimpari,Pune |
Department of Prasutitantra and Strirog, D.Y.Patil Ayurved College and REsearch Center,Pimpari, Pune
Pune
MAHARASHTRA |
09011493626
manisha.deokate1362@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| DYPatil Ayurved college and Research Center |
Approved |
| R.T.Ayu. college, Akola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Female of reproductive age group |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Any menstruating female within 18 to 45 yrs. Willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Participants unable to percieve such as mentally challenged .
female below 18 byrs and above 45 yrs age |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence of artavakshaya and artavavruddhi |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Awareness about ayurved aspects about normal menstruation & menstrual irregularities is judged |
At Baseline |
| relevance of blifestyle modifiction , create awareness |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
30/10/2025 |
| 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="2"
Months="0"
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 study emphasizes on awareness of ayurved in context to normal menstruation and menstrual irregularities. The Primary aim is to find out the prevalence of Menstrual irregularities especially Aartavavriddhi and Aartavakshaya in female of Reproductive age group. the study aims to create awreness about Menstrual irregularities and its relation with Aahar and Vihar . The study will help and discuss and create awreness about implications of menstrual irregularities. |