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

NCT07750899 | Completed

• 1 other identifier: RNN/132/23/KE
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory (BDI-II)

  The Beck Depression Inventory (BDI-II) is a validated 21-item questionnaire assessing symptoms of depression. It includes 21 items, each containing four options, scored on a scale of 0 to 3, where 0 indicates the absence of a symptom and 3 its greatest intensity. Higher scores indicate greater symptom severity (worse outcome). This outcome measures the mean change from baseline in BDI-II total score, where a reduction in score indicates improvement in psychological symptoms.

  Baseline, 3 months, 6 months

Secondary Outcomes (9)

• Perceived Stress Scale (PSS-10)

  Baseline, 3 months, 6 months

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline, 3 months, 6 months

• International Physical Activity Questionnaire - Short Form (IPAQ-SH)

  Baseline, 3 months, 6 months

• Food Frequency Questionnaire (FFQ-6)

  Baseline, 3 months, 6 months

• Complete blood count parameters: white blood cell count (WBC), red blood cell count (RBC), haemoglobin, haematocrit, and platelets concentration

  Baseline, 3 months, 6 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

Withania somnifera, cholecalciferol, folic acid, and 5-methyltetrahydrofolate

Dietary Supplement: Withania somnifera

Control group

ACTIVE COMPARATOR

Cholecalciferol, folic acid, and 5-methyltetrahydrofolate

Dietary Supplement: Active comparator

Interventions

Withania somnifera DIETARY_SUPPLEMENT

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

Treatment Group

Active comparator DIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• a diagnosis confirming the presence of polycystic ovary syndrome,
• age falling within the closed range of 18-45 years,
• absence of pregnancy confirmed by measurement of human chorionic gonadotrophin (β-hCG) levels in serum or urine, or by a gynaecological examination,
• not currently breastfeeding,
• no implanted metallic devices, such as: prostheses, pacemakers, defibrillators, stents, or metallic sutures in the heart or blood vessels,
• no diagnosed epilepsy and no history of epileptic seizures,
• not taking anti-epileptic medication,
• not taking benzodiazepine-based sedatives,
• not taking medicines containing metformin (e.g. Avamina, Formetic, Glucophage, Metformax, Siofor),
• not taking preparations containing oestrogens and/or progestogens,
• not taking dietary supplements.

You may not qualify if:

• no diagnosis confirming the presence of polycystic ovary syndrome,
• age under 18 or over 45,
• pregnancy confirmed by measurement of human chorionic gonadotrophin (β-hCG) levels in serum or urine, or by a gynaecological examination,
• currently breastfeeding,
• having implanted metallic devices, such as: a prosthesis, a pacemaker, a defibrillator, a stent, or a metallic suture in the heart or a blood vessel,
• diagnosed epilepsy or a history of epileptic seizures,
• taking anti-epileptic medication,
• taking benzodiazepine-based sedatives,
• taking medicines containing metformin (e.g. Avamina, Formetic, Glucophage, Metformax, Siofor),
• taking preparations containing oestrogens and/or progestogens,
• poor general health, severe generalised and systemic diseases, including liver and kidney failure, malabsorption syndromes,
• allergy to plants of the nightshade family,
• taking dietary supplements.

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Medical University of Lodz

Lodz, Poland

Location

Related Publications (4)

• Zaki AA, Alharbi NM, Almundarij TI, Albarrak SM. Antioxidant and cytokine modulation in PCOS rats protected with probiotics, myo-inositol, and herbal extracts. Vet Med (Praha). 2025 Jun 27;70(6):203-217. doi: 10.17221/116/2024-VETMED. eCollection 2025 Jun.

  PMID: 40778261 BACKGROUND

• Saiyed A, Jahan N, Makbul SAA, Ansari M, Bano H, Habib SH. Effect of combination of Withania somnifera Dunal and Tribulus terrestris Linn on letrozole induced polycystic ovarian syndrome in rats. Integr Med Res. 2016 Dec;5(4):293-300. doi: 10.1016/j.imr.2016.10.002. Epub 2016 Oct 19.

  PMID: 28462131 BACKGROUND

• Namysl M, Matczak S, Dachowska S, Haraj J, Majcherek E, Sobkowiak M, Bieniek M, Wozniak K. Withania somnifera in Women's Hormonal Modulation: A Narrative Review With Implications for Polycystic Ovary Syndrome and Premenstrual Syndrome. Cureus. 2026 Jan 13;18(1):e101431. doi: 10.7759/cureus.101431. eCollection 2026 Jan.

  PMID: 41694897 BACKGROUND

• Stanczyk K, Lopacinska O, Kedzia D, Gawlik-Kotelnicka O. Depressive and Anxiety Symptoms in Women with Polycystic Ovary Syndrome: A Meta-Analysis. J Clin Med. 2026 May 7;15(10):3582. doi: 10.3390/jcm15103582.

  PMID: 42194542 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Depression

Interventions

Ashwagandha

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: August 6, 2026
• Study Start: January 16, 2025
• Primary Completion: November 20, 2025
• Study Completion: May 29, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-07

Locations

PL (1)