CTRI

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CTRI Number

CTRI/2025/10/096464 [Registered on: 24/10/2025] Trial Registered Prospectively

Last Modified On:

23/10/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Case Control Study

Study Design

Other

Public Title of Study

A study to identify the possible causes of uterine fibroid (Fibroid) according to Ayurveda

Scientific Title of Study

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

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 Khushboo Benuskar
Designation	MS Scholar
Affiliation	All India Institute of Ayurveda
Address	405 Seminar Hall Department of Prasuti tantra evum stree rog All India Institute of Ayurveda New Delhi 110076 South DELHI 110076 India
Phone	7225866414
Fax
Email	benuskarkhushboo@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sujata Kadam
Designation	Professor Head of Department
Affiliation	All India Institute of Ayurveda
Address	405 Seminar Hall Department of Prasuti tantra evum stree rog All India Institute of Ayurveda New Delhi 110076 South DELHI 110076 India
Phone	9890305370
Fax
Email	sujatadkadam@gmail.com

Details of Contact Person
Public Query

Name	Dr Sujata Kadam
Designation	Professor Head of Department
Affiliation	All India Institute of Ayurveda
Address	405 Seminar Hall Department of Prasuti tantra evum stree rog All India Institute of Ayurveda New Delhi 110076 South DELHI 110076 India
Phone	9890305370
Fax
Email	sujatadkadam@gmail.com

Source of Monetary or Material Support

Nil

Primary Sponsor

Name	All India Institute of Ayurveda
Address	Gautampuri Sarita Vihar New Delhi 110076
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 2
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Khushboo Benuskar	All India Institute of Ayurveda	Prasuti tantra evum stree roga , room no 203 South DELHI	7225866414 benuskarkhushboo@gmail.com
Dr Khushboo Benuskar	All India Institute of Ayurveda	Healthy volunteers who come with patient will be enroll for control groups and other opd of hospital South DELHI	7225866414 benuskarkhushboo@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
AIIA Institutional Ethics Commitee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	For control group
Patients	(1) ICD-10 Condition:D259\|\|Leiomyoma of uterus, unspecified. Ayurveda Condition: ARBUDAH,

Intervention / Comparator Agent

sno

Intervention/Comparator

Type

Drug-Type

Procedure Name

Details

Intervention

Nil

Inclusion Criteria

Age From	20.00 Year(s)
Age To	55.00 Year(s)
Gender	Female
Details	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. 2)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

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To identify and analyse the etiological factors responsible for uterine fibroids based on Ayurveda	once in at time of enrollment

Secondary Outcome

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

Target Sample Size

Total Sample Size="300"
Sample Size from India="300"
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

N/A

Date of First Enrollment (India)

01/02/2026

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="2"
Months="0"
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

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.

2. 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 interventions like hysterectomy.

3. 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.

4. 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.

5. 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.

6. 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

7. 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).