MedTrace Logo

The Effect of Standardized Withania Somnifera Extract on Endocrine, Metabolic, and Psychometric Parameters, in Women With Polyendocrine Metabolic Ovarian Syndrome

NCT07750899 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-08-06

No results posted yet for this study

Summary

The objective of this study is to ascertain the impact of a standardized Withania somnifera extract on endocrine, metabolic, and psychometric parameters in women diagnosed with polyendocrine metabolic ovarian syndrome. The assessment will encompass a range of parameters to determine the severity of depression, stress levels, the quality of sleep, blood pressure, body mass index, and body composition. Additionally, biochemical, metabolic, and endocrine blood parameters in serum will be analysed.

The trial's findings may yield a safe and easy-to-use method of adjunctive treatment that could complement therapy in patients with polycystic ovary syndrome.

Conditions

  • Polyendocrine Metabolic Ovarian Syndrome
  • Stress
  • Polycystic Ovarian Syndrome (PCOS)
  • Depression Symptoms

Interventions

DIETARY_SUPPLEMENT

Withania somnifera

Withania somnifera (10 mg of withanolides), cholecalciferol (2000 IU), folic acid (0.4 mg), and 5-methyltetrahydrofolate (0.4 mg) orally once daily

DIETARY_SUPPLEMENT

Active comparator

Cholecalciferol (2000 IU), folic acid (0.4 mg), and 5-methyltetrahydrofolate (0.4 mg) orally once daily

Sponsors & Collaborators

  • Medical University of Lodz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-16
Primary Completion
2025-11-20
Completion
2026-05-29

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07750899 on ClinicalTrials.gov