| CTRI Number |
CTRI/2024/07/070075 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the effect of Lifestyle Modifications in Asrigdhara (Heavy Menstrual flow, Prolonged duration, intermenstrual bleeding) |
|
Scientific Title of Study
|
A Randomized Controlled Trial to Evaluate the Effect of Lifestyle Modifications in Asrigdara |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Durgawati Devi |
| Designation |
Professor & hod |
| Affiliation |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
room no 205 department of Swasthavritta and yoga National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
07073746600 |
| Fax |
|
| Email |
dvd6197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya |
| Designation |
Pg Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
room no 205 department of Swasthavritta and yoga National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9660067567 |
| Fax |
|
| Email |
divyameena67567@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Durgawati Devi |
| Designation |
Professor & hod |
| Affiliation |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
room no 205 department of Swasthavritta and yoga National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur
RAJASTHAN
302002
India |
| Phone |
07073746600 |
| Fax |
|
| Email |
dvd6197@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur Jorawar Singh Gate Amber Road Jaipur Rajasthan |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
Jorawar Singh Gate Amber Road Jaipur Rajasthan 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 |
| Dr Durgawati Devi |
National Institute of Ayurveda Hospital Jaipur |
OPD no 21 National Institute of Ayurveda Jorawar Singh Gate Amber Road
Jaipur
RAJASTHAN |
07073746600
dvd6197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: wake up early morning before sunrise diet will be taken two times a day dinner will be taken between 7:30pm to 8:30pm go to bed between 10pm to 10:30pm divaswapna is prohibited, Ritucarya: , Acara Rasayana:, Other:yoga, Pathya/Apathya:yes, Pathya:shali shashtik yava godhum mudga masoor adaki chanak, Apathya:mash divaswapn multiple time food | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Drakshadi Churna, Reference: Sushrut samhita uttar tantra chapter no 45 shloka 32, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Women between age group 12 to 50 years both married and Unmarried
Patients having any one or two of the following features will be included
Heavy menstrual bleeding
Prolonged menstrual bleeding
Intermenstrual bleeding
Hb percent equal to or more than 8gm dl
Patients with excessive bleeding for at least two consecutive cycles
|
|
| ExclusionCriteria |
| Details |
Patients with bleeding diathesis
Pregnancy
Patients using drugs that may cause vaginal bleeding patients with any organic pathology to explain the bleeding in gynecological examination
Patients using IUCD and OCP
Bleeding followed by abortion
Any systemic disease
History of reproductive system disorder like organic pelvic pathology benign and malignant tumours PID congenital anomalies of genital tract and different types of infections |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
changes in assessment criteria
Assessment Criteria
Asirgdar is assessed by on the basis of following criteria:
Atyadhik matra Heavy amount of menstrual blood
Atyadhik kaal Menstrual phase is more than normal
Anritukala pravritti Menstrual blood flow other than cycle or between cycle |
at base line 30 days 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/07/2024 |
| Date of Study Completion (India) |
10/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/03/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Need
of Study: Asrigdara is very much common in
clinical practices. In modern it is related with AUB having prevalence is
estimated to be 30% .In India, the reported prevalence of Asrigdara(AUB)
is around 17.9%.
Females are very much suffered due to this disease
physically and psychologically. Other contemporary system medicines not
provided sufficient patient friendly
ways to reduce or cure this problem.
Conditions cannot be
corrected until the lifestyle is not modified which is the root cause in
most of the cases . Lifestyle modifications are easy to follow, easily
acceptable and cost effective as well as goes with daily routine easily.
Not any such type of work has been done till now, so
it can provide another treatment option for this disease.
Lifestyle modifications correct the hormonal secretions at various
levels and improve the metabolism which is very much needed in this disease.
Aim
and Objectives:
Aim:
Clinical Evaluation of Lifestyle Modifications in Asrigdara
Objectives:
Evaluation of the effect of Lifestyle Modifications in the terms of Dinacharya,
Aahar and Yoga in Asrigdara through a Randomized
Controlled Trial
Research
Question: Are Lifestyle Modifications effective in Asrigdara?
Null
Hypothesis: There is no effect of Lifestyle Modifications in Asrigdara. |