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NCT04932070
Berberine and Polycystic Ovary Syndrome
NA trial testing Berberine in Polycystic Ovary Syndrome in 12 participants. Completed in 26 January 2021.
6 October 2020
Quick facts
| Lead sponsor | Azienda di Servizi alla Persona di Pavia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 5 September 2020 |
| Primary completion | 6 October 2020 |
| Estimated completion | 26 January 2021 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Berberine — full drug profile →
Conditions studied
- Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
- Berberine — all drugs for Berberine →
Sponsor
Azienda di Servizi alla Persona di Pavia — full company profile →
Who can join
Adults 20 to 35, female only, with Polycystic Ovary Syndrome or Berberine. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Polycystic Ovary Syndrome (PCOS) is the most frequent endocrine disease in female reproductive-age. Recently, increasing evidence has shown that natural plant-based products may play a role in PCOS management. Previous study in PCOS preclinical model and in humans demonstrated that berberine is an effective insulin sensitizer and improves homeostasis of metabolic, inflammatory and hormonal disorders. However, to date there is no clinical study that considers globally all the activities carried out by berberine in PCOS clinical features. Given this background, aim of this study was to evaluate in normal-overweight PCOS women with normal menses the berberine effectiveness on: insulin resistance by Homeostasis Model Assessment (HOMA); inflammation by C-Reactive Protein (CRP), TNF-alpha; lipid metabolism; sex hormone profile and symptoms correlated to hyperandrogenism, such as acne, by Global Acne Grading System (GAGS) and Cardiff Acne Disability Index (CADI); body composition by dual-energy X-ray absorptiometry. All these parameters were collected at baseline and 60 days after supplementation with a new bioavailable and safe berberine formulation. Finally, adverse effects were assessed by liver and kidney functions. To evaluate statistically significant pre- post-supplementation changes, fitted a linear mixed model for each investigated endpoint was performed.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Berberine Phospholipid Is an Effective Insulin Sensitizer and Improves Metabolic and Hormonal Disorders in Women with Polycystic Ovary Syndrome: A One-Group Pretest-Post-Test Explanatory Study.
Rondanelli M, Riva A, Petrangolini G, Allegrini P, et al · · 2021 · cited 26× · PMID 34684666 · DOI 10.3390/nu13103665
Verify or expand the search:
- PubMed search for NCT04932070
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Berberine
Trials testing the same drug.
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- NCT07480018 — Berberine Supplementation, Sprint Interval Training, and Immune Function Study · NA · recruiting
- NCT06911983 — Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabete · NA · not yet recruiting
- NCT05720299 — A Clinical Study to Evaluate the Effects of Akkermansia Muciniphila and Berberine on Prediabetes Among Obese Subjects. · NA · completed
- NCT06514274 — Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Era · Phase 4 · completed
Other recruiting trials for Polycystic Ovary Syndrome
Currently open trials in the same condition.
- NCT07591246 — Efficay of Physical Activity Program in PCOS Females With Fatty Pancrease and Thyroid Hypofunction · NA · recruiting
- NCT07446985 — Is There a Benefit From Addition of Physical Exercise to Diet Restriction/Limitation in PCOS Women With Asthma? · NA · recruiting
- NCT07385716 — Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome · NA · recruiting
- NCT07366944 — PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes · NA · recruiting
- NCT07289399 — Is There a Benefit From Addition of Treadmill Walking to Diet Restriction in Psoriasis Women With PCOS? · NA · recruiting
Other Azienda di Servizi alla Persona di Pavia trials
Trials by the same sponsor.
- NCT07377409 — Beneficial Effects of Supplementation With CRONILIEF™ (Palmitoylethanolamide Phospholipids) in Diabetic Subjects With Ne · NA · not yet recruiting
- NCT06954038 — Evaluate the Beneficial Effects of an Oral Nutritional Supplement Based on Leonurus Cardiaca for the Improvement of Mood · NA · not yet recruiting
- NCT06955234 — Berbevis Dose-finding Study in Subjects With Impaired Fasting Glucose · NA · not yet recruiting
- NCT06942897 — Evaluation of a Dietary Supplement Containing Melissa Officinalis Formulated in Phospholipids on Mood Well-being and Cor · NA · not yet recruiting
- NCT05730985 — From the Gut to the Strut: Reducing Inflammation for Healthy Muscles · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04932070 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azienda di Servizi alla Persona di Pavia
- Last refreshed: 18 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04932070.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing