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

Polycystic Ovarian Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729545
• Other study ID #: JJ2015-42
• Status: Completed
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: May 2018

Study information

• Verified date: September 2019
• Source: Beijing Hospital of Integrated Traditional Chinese and Western Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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).

Locations

Country	Name	City	State
China	Beijing Hospital of Integrated Traditional Chinese and Western Medicine	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LH/FSH Ratio From Baseline to the End of Treatment	the change in LH/FSH ratio, values after 12-week treatment minus the values at baseline	baseline and 12 weeks
Secondary	Change in LH/FSH Ratio From Baseline to the 24th Week	the change in LH/FSH ratio, values at the 24th week minus the values at baseline	baseline to the 24th week
Secondary	Changes in LH From Baseline to the End of Treatment	changes in luteinizing hormone(LH), values after 12-week treatment minus the values at baseline	baseline and 12 weeks
Secondary	Changes in FSH From Baseline to the End of Treatment	changes in follicle-stimulating hormone (FSH), values after 12-week treatment minus the values at baseline	baseline and 12 weeks
Secondary	Changes in Body Mass Index (BMI) From Baseline to the End of Treatment	the changes in BMI, values after 12-week treatment minus the values at baseline	baseline and 12 weeks
Secondary	Changes in Total Testosterone (TT) From Baseline to the End of Treatment	changes in total testosterone (TT) , values after 12-week treatment minus the values at baseline	baseline and 12 weeks
Secondary	Changes in Ovarian Volume From Baseline to the End of Treatment	changes in ovarian volume, values after 12-week treatment minus the values at baseline	baseline and 12 weeks
Secondary	Changes in Polycystic Ovary Number From Baseline to the End of Treatment	the changes in polycystic ovary number, values after 12-week treatment minus the values at baseline	baseline and 12 weeks
Secondary	Changes in the Number of Bleeding Events From Baseline to the End of Treatment	Changes in the number of bleeding events, values after 12-week treatment minus the values at baseline	baseline and 12 weeks