Phase 2
Completed N=60
The Efficacy and Safety Study of Tung's Acupuncture for Polycystic Ovarian Syndrome
Source: ClinicalTrials.gov NCT02729545 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Change in LH/FSH Ratio From Baseline to the End of Treatment — -0.66; -0.96 ratio
Summary
This study evaluates the efficacy and safety in improving ovarian function of polycystic ovarian syndrome in adults. Half of patients will receive Tung's acupuncture therapy, while the other half will receive Diane-35(CPA/EE) as the control group.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in LH/FSH Ratio From Baseline to the End of Treatment |
-0.66; -0.96 | — |
| SECONDARY Change in LH/FSH Ratio From Baseline to the 24th Week |
-0.39; -0.44 | — |
| SECONDARY Changes in LH From Baseline to the End of Treatment |
-3.92; -5.66 | — |
| SECONDARY Changes in FSH From Baseline to the End of Treatment |
-0.49; -0.22 | — |
| SECONDARY Changes in Body Mass Index (BMI) From Baseline to the End of Treatment |
-0.90; -0.44 | — |
| SECONDARY Changes in Total Testosterone (TT) From Baseline to the End of Treatment |
-0.67; -0.33 | — |
| SECONDARY Changes in Ovarian Volume From Baseline to the End of Treatment |
-1.70; -1.03 | — |
| SECONDARY Changes in Polycystic Ovary Number From Baseline to the End of Treatment |
0.00; 0.00 | — |
| SECONDARY Changes in the Number of Bleeding Events From Baseline to the End of Treatment |
0.66; 1.21 | — |
Eligibility Criteria
Inclusion Criteria
- Chinese;
- 18-45 years old;
- to meet the diagnostic criteria for polycystic ovary syndrome;
- no need for pregnancy in the next six months;
- volunteering to join this research and give informed consent prior to receiving treatment.
Exclusion Criteria
- hypertensive patients with blood pressure exceed 160/100 mmHg;
- a history of thrombosis, cerebrolvascular diseases, cancer, liver disease or liver dysfuction, hyperlipidemia, mental disorder, and severe infection;
- having taken any pharmacological treatments affecting reproductive endocrine system;
- having received acupuncture in the previous three months;
- smoking more than 15 cigarettes per day;
- having pacemakers, metal allergies or severe fear of acupuncture.
Data sourced from ClinicalTrials.gov (NCT02729545). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.