Modulation of Hyperandrogenic Anovulation Through Fenugreek Seeds

University of Lahore

Status: Completed

Conditions: Poly Cystic Ovary Syndrome

Treatments: Dietary Supplement: Fenugreek seeds (G2); Drug: Control; Dietary Supplement: Fenugreek seeds (G1):

Study type: Interventional

Funder types: Other

Identifiers

NCT07586969

IRB-UOL-FAHS/930/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 15 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

Control group

Active Comparator group

Description:

• Control group (G0): Participants were only subjected to use Glucophage 500mg 30 minutes before breakfast prescribed by doctor.

Treatment:

Drug: Control

fenugreek seeds low dose

Experimental group

Description:

3gram/ half teaspoon fenugreek seeds powder

Treatment:

Dietary Supplement: Fenugreek seeds (G1):

Fenugreek seeds high dose

Experimental group

Description:

6gram/ one teaspoon fenugreek seeds

Treatment:

Dietary Supplement: Fenugreek seeds (G2)