| CTRI Number |
CTRI/2023/05/052640 [Registered on: 15/05/2023] Trial Registered Prospectively |
| Last Modified On: |
12/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Survey study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing manasa bhava (krodha and bhaya) in perimenopausal women |
|
Scientific Title of Study
|
An observational study to assess manasa bhava (krodha and bhaya) in apparently healthy
women with respect to perimenopause |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kajal Senghani |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
105 Ground Floor Kriya Sharir Department Parul University Limda Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8369630060 |
| Fax |
|
| Email |
kajalsenghani1811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Gadgil |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
105 Ground Floor Kriya Sharir Department Parul University Limda Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9423015868 |
| Fax |
|
| Email |
neha.gadgil86200@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Gadgil |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurveda |
| Address |
105 Ground Floor Kriya Sharir Department Parul University Limda Vadodara 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9423015868 |
| Fax |
|
| Email |
neha.gadgil86200@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurveda Parul University Vadodara Gujarat |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurveda |
| Address |
Ground Floor Kriya sharir Department Parul Institute of Ayurveda
Parul University Limda Vadodara 391760 |
| Type of Sponsor |
Private medical college |
|
|
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 Kajal Senghani |
Parul Institute of Ayurved |
105 Ground Floor Kriya Sharir Department Parul Institute of Ayurveda Parul University Limda Vadodara 391760
Vadodara
GUJARAT |
8369630060
kajalsenghani1811@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Parul Institute of Ayurved Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
For Group 1 perimenopausal women age from 40 to 55 Years
For Group 2 Before perimenopausal women age from 20 to 39 Years |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Apparently healthy females
1 40 to 55 years females for group 1 (both year inclusive)
2 20 to 39 years females for group 2 (both year inclusive)
|
|
| ExclusionCriteria |
| Details |
1 Females who attend menopause for more than 2 years
2 Females underwent Hysterectomy
3 Any case of major psychiatric illness or psychosomatic disorder which affects the manas bhavas |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perimenopause affects the manas bhava |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
one time |
|
|
Target Sample Size
|
Total Sample Size="194"
Sample Size from India="194"
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)
|
21/05/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Perimenopause or the menopausal transition, encompasses that period of time during which physiologic changes mark progression toward a woman’s final menstrual period (FMP). This phase begins with the onset of menstrual irregularities and continues until a woman reaches menopause, or one year after amenorrhea has occurred. Perimenopausal woman due to various reasons disturbance in the Manasa Bhava like Bhaya,Krodha,Chinta etc are observe. Manasa bhava changes in perimenopausal women are either unaware or do not pay adequate attention to these symptoms.Here made an attempt to focus on other side of the coin that is psychological aspects of perimenopause |