NCT07586969

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2025

Completed
10 months until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
Last Updated

May 28, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

July 31, 2025

Last Update Submit

May 22, 2026

Conditions

Keywords

hyperandrogenic Anovulation.Fenugreek (Trigonella foenum-graecum L.)Insulin Resistance

Outcome Measures

Primary Outcomes (1)

  • FSH/LH Test

    Ratio of Follicle Stimulating Hormone (FSH) to Luteinizing Hormone (LH)

    2 months

Study Arms (3)

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

Participants were only subjected to use Glucophage 500mg 30 minutes before breakfast for the duration of 02 months.

Control group
Fenugreek seeds (G1):DIETARY_SUPPLEMENT

Participants were advised to take 3g/half teaspoon fenugreek seeds powder 30 minutes before breakfast for the duration of 02 month.

fenugreek seeds low dose
Fenugreek seeds (G2)DIETARY_SUPPLEMENT

Participants were advised to take 6g/one teaspoon fenugreek seeds powder 30 minutes before breakfast for the duration of 02 months.

Fenugreek seeds high dose

Eligibility Criteria

Age15 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Punjab medical center, jail road, Lahore

Lahore, 54000, Pakistan

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Head University Institute of Diet and Nutritional Sciences

Study Record Dates

First Submitted

July 31, 2025

First Posted

May 14, 2026

Study Start

September 11, 2024

Primary Completion

November 11, 2024

Study Completion

December 11, 2024

Last Updated

May 28, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Locations