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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in LH From Baseline to the End of Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhishun Liu, Doctor | Guang'anmen Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital of Integrated Traditional Chinese and Western Medicine | Beijing | Beijing Municipality | 100039 | China |
to share data by publishing paper
after the paper published around the year of 2020
researchers who are interested in this area
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Participants were recruited through advertisements on local newspapers and posters.Of the 116 individuals who were initially recruited for this trial, 56 were excluded,sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30).
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| ID | Title | Description |
|---|---|---|
| FG000 | Tung's Acupuncture Group | 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). |
| FG001 | CPA/EE Group | CPA/EE 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason. | Posted | Mean | 95% Confidence Interval | ratio | baseline and 12 weeks |
|
24 weeks
No serious adverse event happened, eleven adverse mild events were descriped in the data tables below.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tung's Acupuncture Group | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient bruises at the sites of needle insertion | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yu Cao | Beijing Hospital of Integrated Traditional Chinese and Western Medicine | 086 | 88223667 | howgreenbreeze@126.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 28, 2018 | Apr 15, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D017373 | Cyproterone Acetate |
| D004997 | Ethinyl Estradiol |
| C032640 | Cyproterone acetate, ethinyl estradiol drug combination |
| ID | Term |
|---|---|
| D003534 | Cyproterone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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The study was a randomized, drug-controlled, and parallel group trial
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| 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). |
|
|
changes in luteinizing hormone(LH), values after 12-week treatment minus the values at baseline
| baseline and 12 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Withdrawal by Subject |
|
| 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| course of disease | Mean | Standard Deviation | month |
|
| OG001 | 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). |
|
|
| 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 | During the long-term observation, three participants in the acupuncture group withdrew because of living far away from hospital, pregnancy and taking other medicine. Five participants in the CPA/EE group withdrew because of taking other medicine,pregnancy, losting contact and health reason. | Posted | Mean | 95% Confidence Interval | ratio | 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 | Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason. | Posted | Mean | 95% Confidence Interval | mIU/mL | 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 | Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason. | Posted | Mean | 95% Confidence Interval | mIU/mL | 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 | Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason. | Posted | Mean | 95% Confidence Interval | kg/m^2 | 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 | Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason. | Posted | Mean | 95% Confidence Interval | nmol/L | 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 | Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason. | Posted | Mean | 95% Confidence Interval | cm^3 | 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 | Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason. | Posted | Mean | Inter-Quartile Range | polycystic ovaries | 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 | Sixty participants were randomly assigned to acupuncture group (n = 30) or CPA/EE group (n = 30). During the study period, one participant in the acupuncture group withdrew because of living far away from hospital, two participants in the CPA/EE group withdrew because of taking other medicine and health reason. | Posted | Mean | 95% Confidence Interval | bleeding events | baseline and 12 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 5 |
| 30 |
| EG001 | CPA/EE Group | CPA/EE 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). | 0 | 30 | 0 | 30 | 4 | 30 |
| post-treatment soreness | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |