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Clinical Trials/CTRI/2023/08/057120
CTRI/2023/08/057120Not yet recruitingPhase 1/2

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.

Parul Institute Of Ayurved1 site in 1 country60 target enrollmentStarted: September 15, 2023Last updated:

Trial Snapshot

Phase
Phase 1/2
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Beneficial for irregular prolonged & heavy menses

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Not Applicable

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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..

Outcomes

Primary Outcomes

Beneficial for irregular prolonged & heavy menses

Time Frame: 2 Months with 1 Month followup.

Secondary Outcomes

  • Also reduce symptoms like Angamarda, daurbalya, bhrama, aruchi, daha, trusha.(2 Months with 1 Month followup)

Investigators

Sponsor
Parul Institute Of Ayurved
Sponsor Class
Research institution and hospital

Study Sites (1)

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