NCT02729545

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

The Efficacy and Safety Study of Tung's Acupuncture for Improving Ovarian Function of Polycystic Ovarian Syndrome: a Randomised Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Beijing Hospital of Integrated Traditional Chinese and Western Medicine · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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).
DRUG	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).

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-03-01
• Completion: 2018-05-01
• First posted: 2016-04-06
• Last updated: 2019-10-08
• Results posted: 2019-09-24

Locations

1 site across 1 country: China