Last reviewed · How we verify
NCT05386706
Treating PCOS With Digital Intervention vs. Metformin
NA trial testing Digital Intervention in Polycystic Ovary Syndrome in 80 participants. Completed in 1 September 2023.
12 August 2023
Quick facts
| Lead sponsor | Shanghai 10th People's Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 21 June 2022 |
| Primary completion | 12 August 2023 |
| Estimated completion | 1 September 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Digital Intervention
- Metformin (metformin) — full drug profile →
Conditions studied
- Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
Sponsor
Shanghai 10th People's Hospital
Who can join
Adults 18 to 45, female only, with Polycystic Ovary Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
With the change in environment and lifestyle, and the improvement of people's understanding of PCOS, the incidence of PCOS is increasing worldwide. According to statistics, the prevalence of PCOS in premenopausal women is as high as 5-20%. Lifestyle interventions are the main treatment option for patients with PCOS. In addition, research has shown that digital therapy can effectively improve behavior changes in diet, exercise, and medication adherence, predict disease progression, reduce the frequency of disease-related symptoms, and promote effective disease management. This study aimed to investigate the efficacy of digital intervention versus traditional metformin monotherapy in patients with PCOS.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Digital therapeutics in the clinic.
Phan P, Mitragotri S, Zhao Z. · · 2023 · cited 39× · PMID 37476062 · DOI 10.1002/btm2.10536 -
Efficacy of WeChat-Based Digital Intervention Versus Metformin in Women With Polycystic Ovary Syndrome: Randomized Controlled Trial.
Dilimulati D, Shao X, Wang L, Cai M, et al · · 2024 · cited 8× · PMID 39357046 · DOI 10.2196/55883
Verify or expand the search:
- PubMed search for NCT05386706
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Digital Intervention
Trials testing the same drug.
- NCT06631339 — Optimizing Light Exposure for Myopia Prevention and Control (LightSPAN) · NA · recruiting
- NCT06778785 — Game-Based Digital Intervention for Depression in Adolescents · NA · active not recruiting
- NCT06349993 — Digital Intervention for Depression and Anxiety in Adolescents · NA · recruiting
- NCT05667363 — Digital Therapeutics on Inhalation Medication Adherence in COPD · NA · unknown
- NCT04098016 — Digital Intervention To Improve Diet Quality · NA · 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 Shanghai 10th People's Hospital trials
Trials by the same sponsor.
- NCT07528040 — An Observational, Multicenter Study to Evaluate the Effectiveness of Guselkumab for the Treatment of Participants With C · not yet recruiting
- NCT07370441 — Amino Acid (15) Peritoneal Dialysis Solution for Nutritional Improvement in Peritoneal Dialysis Patients · Phase 4 · not yet recruiting
- NCT07328100 — Efficacy and Safety of Coenzyme I for Injection on Vascular Aging. · NA · not yet recruiting
- NCT06783296 — Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension · NA · not yet recruiting
- NCT07204496 — A Clinical Study on the Safety, Tolerance, and Preliminary Efficacy of γδ-T Cell Injection in the Treatment of Advanced · not yet recruiting
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 NCT05386706 (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 Shanghai 10th People's Hospital
- Last refreshed: 13 November 2023
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/NCT05386706.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing