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NOT YET RECRUITING
NCT06826716
NA

A Study to Assess the Effect of Libifem® (VL-GF-01) on Fertility in Women With Diminished Ovarian Reserve

Sponsor: Vedic Lifesciences Pvt. Ltd.

View on ClinicalTrials.gov

Summary

The present study is a randomized, double-blind, placebo-controlled, parallel clinical study. Approximately 156 participants will be screened, and considering a screening failure rate of 20%, not more than 124 participants will be randomized in a ratio of 1:1 to receive either Libifem® or placebo and will be assigned a unique randomization code. Each group will have not less than 50 completed participants after accounting for a dropout/withdrawal rate of 20%.

Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effect of Libifem® (VL-GF-01) on Fertility in Women With Diminished Ovarian Reserve

Key Details

Gender

FEMALE

Age Range

25 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-02-10

Completion Date

2025-12-10

Last Updated

2025-02-14

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Fenugreek (Trigonella foenum graecum)

Dose: 600 mg/day Regimen: One capsule (300 mg) to be taken twice a day 30 minutes post breakfast and dinner Route of administration: Oral

DIETARY_SUPPLEMENT

Placebo (Maltodextrin)

Dose: 600 mg/day Regimen: One capsule (300 mg) to be taken twice a day 30 minutes post breakfast and dinner Route of administration: Oral

Locations (7)

Sachi Hospital

Ahmedabad, Gujarat, India

Shardaben General Hospital

Ahmedabad, Gujarat, India

Imperial Multispeciality Hospital

Pune, Maharashtra, India

Ashwin Medical Foundations Moraya Multispeciality Hospita

Pune, Maharshtra, India

Jnu ,Jaipur

Jaipur, Rajashthan, India

Pragya Mother & Child care Hospital

Varanasi, Uttar Pradesh, India

Panchsheel Hospital Pvt. Ltd.

Delhi, India