| CTRI Number |
CTRI/2024/03/064074 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
09/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of Pradhana Deha Prakruti with Menstrual Sign and Symptoms during Menses in Mid Age Healthy Women of Belgaum District : An Observational Study
|
|
Scientific Title of Study
|
Correlation of Pradhana Deha Prakruti with Menstrual Sign and Symptoms in Mid Age Healthy Women of Belgaum District An Observational Study
|
| Trial Acronym |
Observational Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrKadambariS |
| Designation |
Assistant Professor |
| Affiliation |
KLE SHRI BMK Ayurved Mahavidyalay Shahpur Belagavi |
| Address |
KLE SHRI BMK Ayurved Mahavidyalay Shahpur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9164503876 |
| Fax |
|
| Email |
ksolankure@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKadambariS |
| Designation |
Assistant Professor |
| Affiliation |
KLE SHRI BMK Ayurved Mahavidyalay Shahpur Belagavi |
| Address |
KLE SHRI BMK Ayurved Mahavidyalay Shahpur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9164503876 |
| Fax |
|
| Email |
ksolankure@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKadambariS |
| Designation |
Assistant Professor |
| Affiliation |
KLE SHRI BMK Ayurved Mahavidyalay Shahpur Belagavi |
| Address |
KLE SHRI BMK Ayurved Mahavidyalay Shahpur Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9164503876 |
| Fax |
|
| Email |
ksolankure@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Shri BMK Ayurved Mahavidyalay Shahpur Belagavi |
|
|
Primary Sponsor
|
| Name |
KLE Academy of Higher Education and Research |
| Address |
KLE Academy of Higher Education and Research Belagavi Nehru Nagar |
| Type of Sponsor |
Other [KLE Academy Of Highe Education and Research ] |
|
|
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 |
| DrKadambariS |
KLE Shri BMK Ayurved Mahavidyalay Belagavi |
KLE Shri BMK Ayurved Mahavidyalay Shahpur Belagavi
Belgaum
KARNATAKA |
9164503876
ksolankure@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committie on Human Subjects KLE University Shri BMK Ayurved Mahavidyalay Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers selected for Prakriti Parikshan and also observing menstrual sign and symptoms in perticular type of Prakriti |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Healthy Females belonging to 18to 40 years of age
Association of Menstrual sign and symptoms at Menarche
|
|
| ExclusionCriteria |
| Details |
Female along with Menstrual Disorders like Irregular Menses, PCOD, Fibroid, etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Guidelines about Diet and daily regimens suitable to predominant constitutional dosha in order to balance them.
publications,Mobile App for lifestyle modification with respect to diet daily regimen and Yoga.
|
Guidelines about Diet and daily regimens suitable to predominant constitutional dosha in order to balance them.
Yogasana practice should encourage the opposite qualities of prakriti that naturlly bring back into balance of dosha.
Yogasana according to prakriti can give physical as well as mental equillibrium to a greater extent.
publications,Mobile App for lifestyle modification with respect to diet daily regimen and Yoga.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
publications,Mobile App for lifestyle modification with respect to diet daily regimen and Yoga.
|
June 2024- final submission of project |
|
|
Target Sample Size
|
Total Sample Size="450"
Sample Size from India="450"
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)
|
30/03/2024 |
| 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="1"
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
|
· This is a Observational study. The healthy volunteers will be included as per the inclusion criteria. Written informed consent will be obtained. The prakriti will be assessed with Validated Prakriti questionnaire and the same individuals will be Observed for Menstrual sign and symptoms during Menses in Healthy women belonging to age group 18 to 40 years. The Menstrual sign and symptoms of these individuals will be assessed with a validated questionnaire. The data will be collected and studied for the coorelation.This study will be applied for institutional ethical clearance..This study has 3 groups namely vataja Prakriti, pittaja prakriti and kaphaja Prakriti. Each group will have samples. Total sample size is 450 healthy volunteers. The obtained data will be statistically analysed for Correlation between the parkriti and Menstrual Sign and Symptoms. |