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

Not Applicable

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: Placebo auricular acupressure; Other: Auricular acupressure

• Registration Number: NCT02326714
• Lead Sponsor: Heilongjiang University of Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-29
• Study Start: 2015-06
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-20
• Primary Completion: 2019-01
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo auricular acupressure	Placebo auricular acupressure	The magnetic beads will be taped to the three pressing points:Tonsil, eye and elbow.
Auricular acupressure	Auricular acupressure	The magnetic beads will be taped to the seven pressing points: Hunger point, Ovary, Uterus, Endocrine point, liver, kidney and spleen.

Primary Outcome Measures

Name	Time	Method
Body mass index (BMI): BMI change at 3 months.	3 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Affiliated Hospital, Heilongjiang University of Chinese Medicine; 🇨🇳 Harbin, Heilongjiang, China