Clinical trial · Interventional
The Effect of Standardized Withania Somnifera Extract on Endocrine, Metabolic, and Psychometric Parameters, in Women With Polyendocrine Metabolic Ovarian Syndrome
The Effect of Standardized Withania Somnifera Extract on Endocrine, Metabolic, and Psychometric Parameters, in Women With Polyendocrine Metabolic Ovarian Syndrome: a Randomized Active-controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Depression Symptoms | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome (PCOS) | — | UNRESOLVED | — |
| Polyendocrine Metabolic Ovarian Syndrome | — | UNRESOLVED | — |
| Stress | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active comparator | Dietary Supplement | — | UNRESOLVED |
| Withania somnifera | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- Withania somnifera, cholecalciferol, folic acid, and 5-methyltetrahydrofolate
- interventionNames
- Dietary Supplement: Withania somnifera
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Cholecalciferol, folic acid, and 5-methyltetrahydrofolate
- interventionNames
- Dietary Supplement: Active comparator
Primary outcomes (1)
- measure
- Beck Depression Inventory (BDI-II)
- timeFrame
- Baseline, 3 months, 6 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (4)
- BACKGROUNDZaki 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
- BACKGROUNDSaiyed 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
- BACKGROUNDNamysl 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
- BACKGROUNDStanczyk 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