Auricular Acupressure (AA) For Overweight/Obese Adolescent and Young Polycystic Ovary Syndrome ( PCOS)

Study Overview
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Brief Summary
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The purpose of this trial is to investigate the effect and safety of auricular acupressure on adolescent and young women with PCOS. Subjects will be randomly assigned in to two arms: Auricular acupressure arm and placebo auricular acupressure, both arms will be treated for three months. Body mass index, oral glucose tolerance test, hormonal profile and metabolic profile will be determined.

Official Title
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Effect of Auricular Acupressure on Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome.

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Other: Auricular acupressure
* Other: Placebo auricular acupressure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged between 12 and 25 years. Diagnosis of PCOS according to the modified Rotterdam criteria. 2 years after menarche. Body mass index (BMI) equal to or greater than 23 kg/m*m. Exclusion Criteria: Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers. Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome. Patients with known severe organ dysfunction or mental illness.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular acupressure<br>The magnetic beads will be taped to the seven pressing points: Hunger point, Ovary, Uterus, Endocrine point, liver, kidney and spleen. | Other: Auricular acupressure<br>* The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were asked to massage the points for 5 minutes, 30 minutes before three meals and sleep.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear.<br>|
| Placebo Comparator: Placebo auricular acupressure<br>The magnetic beads will be taped to the three pressing points:Tonsil, eye and elbow. | Other: Placebo auricular acupressure<br>* The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were not asked to massage the points.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI): BMI change at 3 months. |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral glucose tolerance test (OGTT) |  | 3 month | 
| Testosterone (T) |  | 3 month | 
| Sex hormone-binding globulin (SHBG) |  | 3 month | 
| Dehydroepiandrosterone sulfate (DHEAS). |  | 3 month | 
| Follicle stimulating hormone (FSH) |  | 3 month | 
| Luteinizing hormone (LH) |  | 3 month | 
| Cholesterol |  | 3 month | 
| Triglycerides (TG) |  | 3 month | 
| Waist/hip ratio |  | 3 month | 
| Ferriman-Gallwey score |  | 3 month |