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

NCT02729545 | Completed Phase 2 Results DMC

• 1 other identifier: JJ2015-42
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovarian Syndrome

Keywords

acupuncture; LH/FSH; total testosterone (TT); polycystic ovarian syndrome(PCOS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in LH/FSH Ratio From Baseline to the 24th Week

  baseline to the 24th week

• Changes in LH From Baseline to the End of Treatment

  baseline and 12 weeks

• Changes in FSH From Baseline to the End of Treatment

  baseline and 12 weeks

• Changes in Body Mass Index (BMI) From Baseline to the End of Treatment

  baseline and 12 weeks

• Changes in Total Testosterone (TT) From Baseline to the End of Treatment

  baseline and 12 weeks

Study Arms (2)

Tung's acupuncture

EXPERIMENTAL

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).

Other: Tung's acupuncture

CPA/EE

ACTIVE COMPARATOR

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).

Drug: Cyproterone acetate/ethinylestradiol (CPA/EE)

Interventions

Tung's acupuncture 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).

Tung's acupuncture

Cyproterone acetate/ethinylestradiol (CPA/EE) 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).

Also known as: Diane-35

CPA/EE

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Hospital of Integrated Traditional Chinese and Western Medicine: lead

Study Sites (1)

Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Beijing, Beijing Municipality, 100039, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Cyproterone Acetate; Ethinyl Estradiol; Cyproterone acetate, ethinyl estradiol drug combination

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cyproterone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Norpregnatrienes; Norpregnanes; Norsteroids; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Yu Cao
• Organization: Beijing Hospital of Integrated Traditional Chinese and Western Medicine

howgreenbreeze@126.com

086

Study Officials

• Zhishun Liu, Doctor

  Guang'anmen Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study was a randomized, drug-controlled, and parallel group trial

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 6, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: May 1, 2018
• Last Updated: October 8, 2019
• Results First Posted: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: after the paper published around the year of 2020
• Access Criteria: researchers who are interested in this area

Locations

CN (1)