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

NCT ID: NCT02326714

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-06-30

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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Auricular acupressure

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

Group Type EXPERIMENTAL

Auricular acupressure

Intervention Type OTHER

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

Group Type PLACEBO_COMPARATOR

Placebo auricular acupressure

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Heilongjiang University of Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Yan Li

Associate chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lihui Hou, Bachelor

Role: STUDY_CHAIR

First Affiliated Hospital of Heilongjiang University Of Chinese

Locations

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First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan Li, Doctor

Role: CONTACT

Phone: +86-451-82111401

Email: [email protected]

Facility Contacts

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Lihui Hou, Bachelor

Role: primary

Other Identifiers

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AA for PCOS

Identifier Type: -

Identifier Source: org_study_id