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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02326714
• Other study ID #: AA for PCOS
• Status: Recruiting
• Phase: N/A
• First received: December 11, 2014
• Last updated: December 18, 2017
• Start date: June 2015
• Est. completion date: June 2019

Study information

• Verified date: December 2017
• Source: Heilongjiang University of Chinese Medicine
• Contact: Yan Li, Doctor
• Phone: +86-451-82111401
• Email: liyantcm[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• 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 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.
• Placebo 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.

Locations

Country	Name	City	State
China	First Affiliated Hospital, Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index (BMI): BMI change at 3 months.		3 month
Secondary	Oral glucose tolerance test (OGTT)		3 month
Secondary	Testosterone (T)		3 month
Secondary	Sex hormone-binding globulin (SHBG)		3 month
Secondary	Dehydroepiandrosterone sulfate (DHEAS).		3 month
Secondary	Follicle stimulating hormone (FSH)		3 month
Secondary	Luteinizing hormone (LH)		3 month
Secondary	Cholesterol		3 month
Secondary	Triglycerides (TG)		3 month
Secondary	Waist/hip ratio		3 month
Secondary	Ferriman-Gallwey score		3 month