The Efficacy and Safety Study of Tung's Acupuncture for Polycystic Ovarian Syndrome

NCT ID: NCT02729545

Last Updated: 2019-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-05-31

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.

Conditions

Polycystic Ovarian Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tung's acupuncture

The Tung's acupuncture group received acupuncture treatments twice per week for 12 weeks. The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).

Group Type: EXPERIMENTAL

Tung's acupuncture

Intervention Type: OTHER

The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).

CPA/EE

Cyproterone acetate/ethinylestradiol (CPA/EE) was taken orally one tablet per day from the 8th day of menstrual cycle or any day for patients with amenorrhea. The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).

Group Type: ACTIVE_COMPARATOR

Cyproterone acetate/ethinylestradiol (CPA/EE)

Intervention Type: DRUG

Cyproterone acetate/ethinylestradiol (CPA/EE) contains 2mg cyproterone acetate (an anti-androgenic progestin) and 0.035mg ethinylestradiol (CPA/EE). The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).

Interventions

Tung's acupuncture

The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).

Intervention Type: OTHER

Cyproterone acetate/ethinylestradiol (CPA/EE)

Cyproterone acetate/ethinylestradiol (CPA/EE) contains 2mg cyproterone acetate (an anti-androgenic progestin) and 0.035mg ethinylestradiol (CPA/EE). The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).

Intervention Type: DRUG

Other Intervention Names

Diane-35

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhishun Liu, Doctor

Role: STUDY_DIRECTOR

Guang'anmen Hospital

Locations

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Beijing, Beijing Municipality, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

JJ2015-42

Identifier Type: -

Identifier Source: org_study_id