Modulation of Hyperandrogenic Anovulation Through Fenugre... | NCT07586969

Studies
Modulation of Hyperandrogenic Anovulation Through Fenugreek Seeds

NCT07586969

Sponsor

University of Lahore

Status

Completed

Last Update Posted

May 28, 2026Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Poly Cystic Ovary Syndrome

Interventions

Control
Fenugreek seeds (G1):
Fenugreek seeds (G2)

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2024Actual

Primary Completion Date

Nov 11, 2024Actual

Completion Date

Dec 11, 2024Actual

First Submitted Date

Jul 31, 2025

First Submission Date that Met QC Criteria

May 8, 2026

First Posted Date

May 14, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2026

Last Update Posted Date

May 28, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Aslam, Clinical Head University Institute of Diet and Nutritional Sciences, University of LahorePrincipal Investigator

Lead Sponsor

University of LahoreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Hyperandrogenic anovulation is a common gynecological illness that impacts the ovaries, vagina and uterus. According to Statistics, in Pakistan 17.6% of individuals seeking treatment at infertility clinics were found to be affected by hyperandrogenic anovulation. Studies indicate that fenugreek seeds have the potential to improve insulin sensitivity, control hormone levels, namely the increased androgens linked to hyperandrogenic anovulation, and promote ovulation, a process commonly interrupted in individuals with hyperandrogenic anovulation. In order to create a therapy plan that is both affordable and easily accessible for women who suffer from hyperandrogenic anovulation, this study aims to determine the therapeutic efficacy of fenugreek seed powder in reducing symptoms related to the illness. Furthermore, it aims to increase knowledge on the extensive utilization of fenugreek seed powder as a natural treatment for hyperandrogenic anovulation.

Detailed Description

To collect data, written consent was obtained from the hospital and university administration.
After receiving signed informed consent, the data were collected.
1. Screening: The participants who meet the study inclusion criteria were enrolled and FSH/LH, Insulin resistance or lipid profile samples were taken by the hospital lab assistant. The participants will be requested not to alter their routine physical activity.
2. Allocation: Following screening, participants were divided evenly into three groups: experimental group (1, 2) and one control group. The participants received different dosage in different experimental groups of fenugreek seeds powder) c.Follow up: A systematic communication plan will be developed in order to follow up with participants on their daily consumption of the suggested fenugreek powder through telephonic conversations. For continuous assistance there was a WhatsApp group set up where members may ask issues and get help associated with hyperandrogenic anovulation. The follow up for patients were conducted every month; baseline and after 60 days. Appointments for follow-up exams were made in order to track developments, anthropometric measurements were calculated every follow up and modify the dosage as necessary. The baseline and post study test were compared to test the hypothesis.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Active Comparator	• Control group (G0): Participants were only subjected to use Glucophage 500mg 30 minutes before breakfast prescribed by doctor.	Drug: Control
fenugreek seeds low dose	Experimental	3gram/ half teaspoon fenugreek seeds powder	Dietary Supplement: Fenugreek seeds (G1):
Fenugreek seeds high dose	Experimental	6gram/ one teaspoon fenugreek seeds	Dietary Supplement: Fenugreek seeds (G2)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Control	Drug	Participants were only subjected to use Glucophage 500mg 30 minutes before breakfast for the duration of 02 months.	Control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
FSH/LH Test	Ratio of Follicle Stimulating Hormone (FSH) to Luteinizing Hormone (LH)	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female have been BMI more than 25
Patients with irregular periods or hormonal imbalance
Patients with age 15 to 25 years of young females

Exclusion Criteria:

Pregnant & Lactating Women
Any history of allergic reaction to fenugreek seeds
Severe gastrointestinal disorders like crohn's disease
People with liver or kidney issue

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Punjab medical center, jail road, Lahore		Lahore		54000	Pakistan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26516311	Result	Swaroop A, Jaipuriar AS, Gupta SK, Bagchi M, Kumar P, Preuss HG, Bagchi D. Efficacy of a Novel Fenugreek Seed Extract (Trigonella foenum-graecum, Furocyst) in Polycystic Ovary Syndrome (PCOS). Int J Med Sci. 2015 Oct 3;12(10):825-31. doi: 10.7150/ijms.13024. eCollection 2015.

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases