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Clinical Trials/CTRI/2025/10/096464
CTRI/2025/10/096464Not yet recruitingNot Applicable

A CASE CONTROL STUDY TO EVALUATE ETIOLOGICAL FACTORS OF ARBUD (UTERINE FIBROID) W.S.R. TO AYURVEDA

All India Institute of Ayurveda1 site in 1 country300 target enrollmentStarted: February 1, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
300
Locations
1
Primary Endpoint
To identify and analyse the etiological factors responsible for uterine fibroids based on Ayurveda

Study Overview

Brief Summary

Research Question-

Does the ayurvedic Nidan (set of causes) play significant role in the present time in developing Arbud (uterine fibroid).

Hypothesis –

There is a significant association between etiological factors and the occurrence of Arbud(uterine fibroids).

Null Hypothesis –

Etiological factors do not play a significant role in the present time in the development of Arbud(uterine fibroid).

Alternate Hypothesis  –

Etiological factors play a significant role in the present time in development of Arbud(uterine fibroid).

Need of study-

  1. Rising Incidence and Earlier Onset

Recent years have seen a rise in the prevalence of uterine fibroids, with cases being diagnosed at younger ages. Changes in lifestyle, stress levels, obesity, and dietary patterns may be contributing factors. Understanding the evolving etiological landscape is essential for early detection and management.

  1. Impact on Women’s Health and Quality of Life

Fibroids significantly affect women’s reproductive and general health, causing symptoms such as heavy menstrual bleeding, pelvic pain, infertility, pregnancy complications, and anaemia. They impair quality of life and impose a large economic burden on healthcare systems due to medical treatments and surgical interventionslike hysterectomy.

  1. Shift in Risk Factors

Modern lifestyle changes, including sedentary behaviour, altered diet, increased exposure to endocrine disruptors (like plastics and chemicals), and hormonal imbalances, are suspected new contributors. However, scientific validation through updated studies is lacking, making contemporary research critical.

  1. Need for Preventive Strategies

By identifying modifiable risk factors, this study can help in developing preventive strategies such as dietary modifications, weight management, hormonal regulation, and minimizing chemical exposures. Early interventions could reduce the need for invasive treatments like surgeries.

  1. Integrating Traditional and Modern Perspectives

Incorporating traditional knowledge systems like Ayurveda with modern medicine can offer a holistic understanding of fibroid aetiology and management, promoting integrative healthcare approaches suited for today’s population.

  1. Gaps in Regional Data (especially India and Delhi)

There is limited epidemiological data specific to the Indian population and regions like Delhi regarding fibroid prevalence and etiological factors. This study fills a critical gap, helping policymakers, clinicians, and public health experts to design targeted health programs for Indian women

  1. Addressing Reproductive Health Challenges

In the modern era, when women are increasingly delaying childbirth for career and educational goals, uterine fibroids pose significant reproductive challenges. Studying fibroids now is key to protecting and optimizing women’s reproductive potential.

Objectives-

Primary-

To identify and analyse the etiological factors responsible for uterine fibroids based on Ayurveda.

Secondary -

To compare the etiological factors  in women with and without uterine fibroids based on Ayurveda nidan(set of causes).

Study Design

Study Type
Observational

Eligibility Criteria

Ages
20.00 Year(s) to 55.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • GROUP A- CASE Inclusion criteria- 1)Married and unmarried female patients aged 20 – 55 years with a diagnosis of uterine fibroid of all types and sizes confirmed by USG (ultrasonography) or MRI.
  • Patients those who are willing to participates GROUP B – CONTROLS INCLUSION CRITERIA- 1.No Fibroids, adenomyosis, ovarian cyst, endometriosis, polyp, Carcinoma, bulky uterus on ultrasound.
  • 2.Willing to participate and provide consent.

Exclusion Criteria

  • Both Groups- Cases with any Systematic illness like Diabetes, Hypertension Pregnancy.

Outcomes

Primary Outcomes

To identify and analyse the etiological factors responsible for uterine fibroids based on Ayurveda

Time Frame: once in at time of enrollment

Secondary Outcomes

  • To compare the etiological factors in women with & without uterine fibroids based on Ayurveda nidan(set of causes).(once in at time of enrollment)

Investigators

Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Khushboo Benuskar

All India Institute of Ayurveda

Study Sites (1)

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