Clinical trial NCT02729545: The Efficacy and Safety Study of Tung's Acupuncture for Polycystic Ovarian Syndrome
Official title: The Efficacy and Safety Study of Tung's Acupuncture for Improving Ovarian Function of Polycystic Ovarian Syndrome: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polycystic Ovarian Syndrome
Keywords: acupuncture
LH/FSH
total testosterone (TT)
polycystic ovarian syndrome(PCOS)
Lead sponsor: Beijing Hospital of Integrated Traditional Chinese and Western Medicine
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was a randomized, drug-controlled, and parallel group trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: Both Tung's acupuncture therapy and Diane-35(CPA/EE) could improve the symptom of patients with polycystic ovarian syndrome, but until now there is no definite evidence to indicate acupuncture could play the same role in improving ovarian function. So we design this study to observe the change of follicular development, ovary size and sex hormone( testosterone, follitropin, luteinizing hormone) before and after the treatment, and evaluate the efficacy and safty of acupuncture.

Eligibility criteria: Inclusion Criteria:

1. Chinese;
2. 18-45 years old;
3. to meet the diagnostic criteria for polycystic ovary syndrome;
4. no need for pregnancy in the next six months;
5. volunteering to join this research and give informed consent prior to receiving treatment.

Exclusion Criteria:

1. hypertensive patients with blood pressure exceed 160/100 mmHg;
2. a history of thrombosis,cerebrolvascular diseases, cancer, liver disease or liver dysfuction, hyperlipidemia, mental disorder, and severe infection;
3. having taken any pharmacological treatments affecting reproductive endocrine system;
4. having received acupuncture in the previous three months;
5. smoking more than 15 cigarettes per day;
6. having pacemakers, metal allergies or severe fear of acupuncture.

Primary outcomes:
measure: Change in LH/FSH Ratio From Baseline to the End of Treatment
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change in LH/FSH Ratio From Baseline to the 24th Week
timeFrame: baseline to the 24th week
measure: Changes in LH From Baseline to the End of Treatment
timeFrame: baseline and 12 weeks
measure: Changes in FSH From Baseline to the End of Treatment
timeFrame: baseline and 12 weeks
measure: Changes in Body Mass Index (BMI) From Baseline to the End of Treatment
timeFrame: baseline and 12 weeks
measure: Changes in Total Testosterone (TT) From Baseline to the End of Treatment
timeFrame: baseline and 12 weeks
measure: Changes in Ovarian Volume From Baseline to the End of Treatment
timeFrame: baseline and 12 weeks
measure: Changes in Polycystic Ovary Number From Baseline to the End of Treatment
timeFrame: baseline and 12 weeks
measure: Changes in the Number of Bleeding Events From Baseline to the End of Treatment
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital of Integrated Traditional Chinese and Western Medicine
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital
name: Zhishun Liu, Doctor
role: STUDY_DIRECTOR
References: