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

Sponsor

Heilongjiang University of Chinese Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT02326714

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Other: Auricular acupressure Other: Placebo auricular acupressure	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Jan 1, 2019

Anticipated Study Completion Date :

Jun 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Auricular acupressure

The magnetic beads will be taped to the seven pressing points: Hunger point, Ovary, Uterus, Endocrine point, liver, kidney and spleen.

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 Comparator: Placebo auricular acupressure

The magnetic beads will be taped to the three pressing points:Tonsil, eye and elbow.

Other: 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.

Outcome Measures

Primary Outcome Measures

Body mass index (BMI): BMI change at 3 months. [3 month]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 25 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital, Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang	China	150040

Sponsors and Collaborators

Heilongjiang University of Chinese Medicine

Investigators

Study Chair: Lihui Hou, Bachelor, First Affiliated Hospital of Heilongjiang University Of Chinese

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yan Li, Associate chief physician, Heilongjiang University of Chinese Medicine

ClinicalTrials.gov Identifier:

NCT02326714

Other Study ID Numbers:

AA for PCOS

First Posted:

Dec 29, 2014

Last Update Posted:

Dec 20, 2017

Last Verified:

Dec 1, 2017

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Overweight

Study Results

No Results Posted as of Dec 20, 2017