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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729545
Recruitment Status : Completed
First Posted : April 6, 2016
Results First Posted : September 24, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Beijing Hospital of Integrated Traditional Chinese and Western Medicine

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovarian Syndrome Other: Tung's acupuncture Drug: Cyproterone acetate/ethinylestradiol (CPA/EE) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study was a randomized, drug-controlled, and parallel group trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety Study of Tung's Acupuncture for Improving Ovarian Function of Polycystic Ovarian Syndrome: a Randomised Controlled Trial
Actual Study Start Date : April 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
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).

Active Comparator: 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).
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).
Other Name: Diane-35




Primary Outcome Measures :
  1. Change in LH/FSH Ratio From Baseline to the End of Treatment [ Time Frame: baseline and 12 weeks ]
    the change in LH/FSH ratio, values after 12-week treatment minus the values at baseline


Secondary Outcome Measures :
  1. Change in LH/FSH Ratio From Baseline to the 24th Week [ Time Frame: baseline to the 24th week ]
    the change in LH/FSH ratio, values at the 24th week minus the values at baseline

  2. Changes in LH From Baseline to the End of Treatment [ Time Frame: baseline and 12 weeks ]
    changes in luteinizing hormone(LH), values after 12-week treatment minus the values at baseline

  3. Changes in FSH From Baseline to the End of Treatment [ Time Frame: baseline and 12 weeks ]
    changes in follicle-stimulating hormone (FSH), values after 12-week treatment minus the values at baseline

  4. Changes in Body Mass Index (BMI) From Baseline to the End of Treatment [ Time Frame: baseline and 12 weeks ]
    the changes in BMI, values after 12-week treatment minus the values at baseline

  5. Changes in Total Testosterone (TT) From Baseline to the End of Treatment [ Time Frame: baseline and 12 weeks ]
    changes in total testosterone (TT) , values after 12-week treatment minus the values at baseline

  6. Changes in Ovarian Volume From Baseline to the End of Treatment [ Time Frame: baseline and 12 weeks ]
    changes in ovarian volume, values after 12-week treatment minus the values at baseline

  7. Changes in Polycystic Ovary Number From Baseline to the End of Treatment [ Time Frame: baseline and 12 weeks ]
    the changes in polycystic ovary number, values after 12-week treatment minus the values at baseline

  8. Changes in the Number of Bleeding Events From Baseline to the End of Treatment [ Time Frame: baseline and 12 weeks ]
    Changes in the number of bleeding events, values after 12-week treatment minus the values at baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729545


Locations
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China, Beijing
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
Beijing, Beijing, China, 100039
Sponsors and Collaborators
Beijing Hospital of Integrated Traditional Chinese and Western Medicine
Investigators
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Study Director: Zhishun Liu, Doctor Guang'anmen Hospital
  Study Documents (Full-Text)

Documents provided by Beijing Hospital of Integrated Traditional Chinese and Western Medicine:
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Responsible Party: Beijing Hospital of Integrated Traditional Chinese and Western Medicine
ClinicalTrials.gov Identifier: NCT02729545    
Other Study ID Numbers: JJ2015-42
First Posted: April 6, 2016    Key Record Dates
Results First Posted: September 24, 2019
Last Update Posted: October 8, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: to share data by publishing paper
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: after the paper published around the year of 2020
Access Criteria: researchers who are interested in this area
Keywords provided by Beijing Hospital of Integrated Traditional Chinese and Western Medicine:
acupuncture
LH/FSH
total testosterone (TT)
polycystic ovarian syndrome(PCOS)
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Cyproterone Acetate
Ethinyl Estradiol
Cyproterone
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Androgen Antagonists
Hormone Antagonists
Antineoplastic Agents
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents