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

Primary Purpose

Polycystic Ovarian Syndrome

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tung's acupuncture
Cyproterone acetate/ethinylestradiol (CPA/EE)
Sponsored by
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovarian Syndrome focused on measuring acupuncture, LH/FSH, total testosterone (TT), polycystic ovarian syndrome(PCOS)

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Hospital of Integrated Traditional Chinese and Western Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tung's acupuncture

CPA/EE

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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
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
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
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
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

Full Information

First Posted
March 29, 2016
Last Updated
September 25, 2019
Sponsor
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02729545
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Hospital of Integrated Traditional Chinese and Western Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome
Keywords
acupuncture, LH/FSH, total testosterone (TT), polycystic ovarian syndrome(PCOS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
The study was a randomized, drug-controlled, and parallel group trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tung's acupuncture
Arm Type
Experimental
Arm Description
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).
Arm Title
CPA/EE
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Tung's acupuncture
Intervention Description
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
Drug
Intervention Name(s)
Cyproterone acetate/ethinylestradiol (CPA/EE)
Other Intervention Name(s)
Diane-35
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in LH/FSH Ratio From Baseline to the End of Treatment
Description
the change in LH/FSH ratio, values after 12-week treatment minus the values at baseline
Time Frame
baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change in LH/FSH Ratio From Baseline to the 24th Week
Description
the change in LH/FSH ratio, values at the 24th week minus the values at baseline
Time Frame
baseline to the 24th week
Title
Changes in LH From Baseline to the End of Treatment
Description
changes in luteinizing hormone(LH), values after 12-week treatment minus the values at baseline
Time Frame
baseline and 12 weeks
Title
Changes in FSH From Baseline to the End of Treatment
Description
changes in follicle-stimulating hormone (FSH), values after 12-week treatment minus the values at baseline
Time Frame
baseline and 12 weeks
Title
Changes in Body Mass Index (BMI) From Baseline to the End of Treatment
Description
the changes in BMI, values after 12-week treatment minus the values at baseline
Time Frame
baseline and 12 weeks
Title
Changes in Total Testosterone (TT) From Baseline to the End of Treatment
Description
changes in total testosterone (TT) , values after 12-week treatment minus the values at baseline
Time Frame
baseline and 12 weeks
Title
Changes in Ovarian Volume From Baseline to the End of Treatment
Description
changes in ovarian volume, values after 12-week treatment minus the values at baseline
Time Frame
baseline and 12 weeks
Title
Changes in Polycystic Ovary Number From Baseline to the End of Treatment
Description
the changes in polycystic ovary number, values after 12-week treatment minus the values at baseline
Time Frame
baseline and 12 weeks
Title
Changes in the Number of Bleeding Events From Baseline to the End of Treatment
Description
Changes in the number of bleeding events, values after 12-week treatment minus the values at baseline
Time Frame
baseline and 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chinese; 18-45 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhishun Liu, Doctor
Organizational Affiliation
Guang'anmen Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
to share data by publishing paper
IPD Sharing Time Frame
after the paper published around the year of 2020
IPD Sharing Access Criteria
researchers who are interested in this area

Learn more about this trial

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

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