| CTRI Number |
CTRI/2023/08/057120 [Registered on: 31/08/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Mustadi Ghanavati and Bolabaddha Rasa in Excessive Menstural Bleeding. |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Mustadi Ghanavati And Bolabaddha Rasa In The Management Of Asrigdara W.S.R 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)
|
| Name |
Dr Jeenal Patel |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Room No. 309, Department of Prasuti Tantra Evum Stree Roga,Parul University
Vadodara
GUJARAT
391760
India |
| Phone |
8238542625 |
| Fax |
|
| Email |
jeenalpatel7297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lumi Bhagat |
| Designation |
Associate Professor , H.O.D of PTSR department |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Room No. 309, Department of Prasuti Tantra Evum Stree Roga,Parul University
Vadodara
GUJARAT
391760
India |
| Phone |
8319352370 |
| Fax |
|
| Email |
lumibhagat31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lumi Bhagat |
| Designation |
Associate Professor , H.O.D of PTSR department |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Room No. 309, Department of Prasuti Tantra Evum Stree Roga,Parul University
Vadodara
GUJARAT
391760
India |
| Phone |
8319352370 |
| Fax |
|
| Email |
lumibhagat31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurved Hospital, Parul University , Vadodara 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurved |
| Address |
Room no 308, Department Of Prasuti Tantra Evum Stree Roga, Parul Institute Of Ayurveda,
Parul University PO Limda Tal Waghodia
Vadodara GUJARAT 391760 India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jeenal Patel |
Parul Institute of Ayurved |
Room No. 309,
Department of Prasuti
Tantra Evum Stree
Roga, Parul Institute of
Ayurved, Parul
University
Vadodara
GUJARAT |
8238542625
jeenalpatel7297@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: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 | Drug | Classical | | (1) Medicine Name: Musatdi Ghanavati, Reference: Sahastra Yoga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bolabaddha Rasa, Reference: Bharat Bhaisajya Ratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients who were willing for the hospital trial.
2.Patients fulfilling the diagnostic criteria.
3.Patients diagnosed as DUB (without organic pathology)
4.Both married and unmarried women. |
|
| ExclusionCriteria |
| Details |
1.Patients not willing for trial.
2.Patients with systemic disorders interfering with the present study like HTN, DM.
3.Patients with IUCD and patients taking OCPs.
4.Patients with uterine and pelvic pathology (fibroid, adenomyosis ) ,Benign and malignant growth in uterus.
5.Patient with Hb < 7 gm%
6.Threatened, spontaneous or incomplete abortion,Endometrial and endocervical polyp.. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Beneficial for irregular prolonged & heavy menses |
2 Months with 1 Month followup. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Also reduce symptoms like Angamarda, daurbalya, bhrama, aruchi, daha, trusha. |
2 Months with 1 Month followup |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2023 |
| 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="6"
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
|
The process of cyclic menstruation is natural phenomenon. Regular cyclic menstruation results from the relationship between the endometrium and its regulating factors. Menstruation denotes the healthy state of female reproductive system but if the cycle turns to be abnormal with excessive and prolonged bleeding, associated with pain or during intermenstrua lperiod, it is suggestive of some underlying pathology. In modern science asrigdara can be closely co-related with DUB. Dysfunctional uterine bleeding is best defined as abnormal uterine bleeding without any clinically detectable organic, systemic and iatrogenic cause (pelvic pathology i.e tumors, inflammation or pregnancy is excluded). The current line of treatment include medical and surgical methods, plays insignificant role besides the adverse effects. Hormones play a major role in the management of DUB (Asrigdara) but their use for longer period is proved to be dangerous and sometimes induce carcinogenic effect on the genital tract. In view of the problems of the current therapies, need is felt to revalidate certain ayurvedic formulations for the management of asrigdara without adverse effects. Aim To compare the effect of Mustadi Ghanavati and Bolbaddha Rasa in the management of Asrigdara . Objectives To study the Aetiopathogenesis of Asrigdara with special reference to dysfunctional uterine bleeding. To evaluate the efficacy of Mustadi Ghanavati. To compare the efficacy of Mustadi Ghanavati and Bolbaddha Rasa in Asrigdara.
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