| CTRI Number |
CTRI/2018/04/013081 [Registered on: 06/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of two Ayurveda medicines in patients with excessive menstrual bleeding |
|
Scientific Title of Study
|
A comparative clinical study of Shonitasthapana Mahakashaya and Bolabaddha Rasa in the management of Asrigdara with special reference to dysfunctional uterine bleeding |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr khushbu jain |
| Designation |
PhD scholar |
| Affiliation |
National institute of ayurveda |
| Address |
National institute of ayurveda, Madhav vilas palace, Jorawar Singh Gate, Amer road
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414744475 |
| Fax |
|
| Email |
khushbuayur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sushila Sharma |
| Designation |
Professor |
| Affiliation |
National institute of ayurveda |
| Address |
PG Department of Prasuti and Stree Roga National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
9660843984 |
| Fax |
|
| Email |
sushila.sharma.s@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Sushila Sharma |
| Designation |
Professor |
| Affiliation |
National institute of ayurveda |
| Address |
PG Department of Prasuti and Stree Roga National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
9660843984 |
| Fax |
|
| Email |
sushila.sharma.s@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of ayurveda, Madhav Vilas Palace, Jorawar Singh Gate, Amer road, jaipur-302002, Rajasthan |
|
|
Primary Sponsor
|
| Name |
National institute of Ayurveda |
| Address |
Jorawar Singh gate, Jaipur, Rajasthan |
| 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 khushbu jain |
National institute of ayurveda jaipur |
Prasuti and Stree roga department 3rd floor Room no.320
Jaipur
RAJASTHAN |
9414744475
khushbuayur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, National institute of ayurveda, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dysfunctional uterine bleeding, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bolabaddha rasa |
500 mg BD orally with Madhu as Sahapana for 60 days |
| Intervention |
Shonitasthapana mahakashaya Ghana |
500 mg BD orally with Madhu as sahapana for 60 days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients complaining of Asrigdara as a cardinal symptom.
1.Heavy menstrual bleeding (amount >80ml) or
2.Prolonged menstrual bleeding (duration >7 days) or
3.Inter menstrual bleeding or
4.Frequent menstrual cycle (interval< 21 days)
|
|
| ExclusionCriteria |
| Details |
1.Pregnant women.
2.Patients having bleeding due to abortion.
3.Patients having bleeding after menopause.
4.Patients having coagulation disorders.
5.Any type of malignancy.
6.Patients having STIs.
7.Patients having systemic diseases.
8.Patients having bleeding due to uterine or pelvic pathology
9.Patients using IUCD.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms and signs of dysfunctional uterine bleeding |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Restoration of normal menstrual cycle i.e amount and interval |
6 months |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/10/2017 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present clinical study entitled “A Comparative Clinical Study Of Shonitasthapana Mahakashaya And Bolabaddha Rasa In The Management Of Asrigdara With Special Reference To
Dysfunctional Uterine Bleeding†is randomized parallel group trial to compare the efficacy of Shonitasthapana Mahakashaya Ghana 500 mg BD and Bolabaddha Rasa 500 mg BD for 2 months with following aims and objectives 1. To study the conceptual aspect of Asrigdara according to Ayurveda. 2. To study the detailed etio-pathogenesis of the Asrigdara according to Ayurveda and modern literature. 3. To evaluate the therapeutic efficacy of Shonitasthapana Mahakashaya on Asrigdara. 4. To evaluate the therapeutic efficacy of Bolabaddha Rasa on Asrigdara. 5. Comparative study of Shonitasthapana Mahakashaya and Bolabaddha Rasa on Asrigdara.
Assessment will be done on the basis of subjective parameters i.e amount of bleeding, interval of cycle, bodyache , giddiness etc, objective
parameters i.e pallor and laboratory investigations i.e CBC and ESR |