| CTRI Number |
CTRI/2022/07/044349 [Registered on: 26/07/2022] Trial Registered Prospectively |
| Last Modified On: |
12/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Retrospective observational study on the causes of excessive menstrual bleeding |
|
Scientific Title of Study
|
A Retrospective Observational Study on the Aetiology of
Asrigdara |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharathi Kumaramangalam |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda
Deemed University
Jorawar Singh Gate
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9492047131 |
| Fax |
|
| Email |
baruhunt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bharathi Kumaramangalam |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda
Deemed University
Jorawar Singh Gate
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9492047131 |
| Fax |
|
| Email |
baruhunt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharathi Kumaramangalam |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda
Deemed University
Jorawar Singh Gate
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9492047131 |
| Fax |
|
| Email |
baruhunt@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Deemed to be University Jaipur |
| Address |
National Institute of Ayurveda Deemed to be University Joarawar Singh Gate Jaipur 302002 |
| Type of Sponsor |
Government 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 |
| Bharathi Kumaramangalam |
Madhav vilas hospital OPD 26 and 27 |
National Institute of Ayurveda
Jorawar Singh Gate
Amer Road
jaipur
Jaipur
RAJASTHAN |
9492047131
baruhunt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N939||Abnormal uterine and vaginal bleeding, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women with PBAC score of ≥100 will be recruited in the study
|
|
| ExclusionCriteria |
| Details |
Women who are taking or taken contraceptives like OCPs, IUCD.
Women diagnosed with endometrial cancers.
Women with coagulatory defects |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Confirmation of causitive factors |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlate the classical Nidana factors with observed nidana factors |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/08/2022 |
| 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
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Abnormal uterine bleeding affects 10-30% of reproductive aged
woman and up to 50% of peri-menopausal woman. The prevalence of
abnormal uterine bleeding due to DUB was 50.90%, which is more
commonly seen in age group 20-40 years. The prevalence of puberty
menorrhagia was 8.20% in general and 51% among age group <20
years.
Various reports suggest that 30 to 50% of women in the reproductive
age group suffer from excessive and irregular uterine bleeding.
Among them 28% of the female population having excessive
menstruation do not plan their social activities around their menstrual
cycle, and nearly 10% of employed women need to take time off work
because of excessive menstrual loss; 6 % of women aged 25 to 44
consult their General practitioners about excessive menstrual loss
every year. 35 % of these referred to hospital, 60 % will have a
hysterectomy in the next 5 years, and over 75000 hysterectomies are
now carried out every year with 30 % of them carried out for
menstrual disturbances alone.
In Ayurveda exact aetiology and risk factors for the development of
the disease is identified. This includes diet, dietary habits, lifestyle,
psychological factors etc. In the present study an attempt will be made
to establish connection between the aetiological/risk factors causing
Asrigdara including the so far unidentified factorsin causing the onset
of Asirgdara AIM: To assess the probable etiological factors described under the
general and specific aetiology of the Asrigdara in Ayurveda. OBJECTIVES: To establish the relationship between
aetiological factors and disease manifestation |