Polycystic Ovary Syndrome
Conditions
Brief summary
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.
Interventions
OTHERAuricular acupressure
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.
OTHERPlacebo auricular acupressure
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.
Sponsors
Heilongjiang University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body mass index (BMI): BMI change at 3 months. | 3 month |
Secondary
| Measure | Time frame |
|---|---|
| Testosterone (T) | 3 month |
| Sex hormone-binding globulin (SHBG) | 3 month |
| Dehydroepiandrosterone sulfate (DHEAS). | 3 month |
| Follicle stimulating hormone (FSH) | 3 month |
| Oral glucose tolerance test (OGTT) | 3 month |
| Cholesterol | 3 month |
| Triglycerides (TG) | 3 month |
| Waist/hip ratio | 3 month |
| Ferriman-Gallwey score | 3 month |
| Luteinizing hormone (LH) | 3 month |
Countries
China
Contacts
Primary ContactYan Li, Doctor
Outcome results
None listed