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

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Auricular acupressure
Placebo auricular acupressure
Sponsored by
Heilongjiang University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

12 Years - 25 Years (Child, Adult)FemaleDoes not accept 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.

Sites / Locations

  • First Affiliated Hospital, Heilongjiang University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Auricular acupressure

Placebo auricular acupressure

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 11, 2014
Last Updated
December 18, 2017
Sponsor
Heilongjiang University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02326714
Brief Title
Auricular Acupressure (AA) For Overweight/Obese Adolescent and Young Polycystic Ovary Syndrome ( PCOS)
Official Title
Effect of Auricular Acupressure on Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heilongjiang University of Chinese Medicine

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Auricular acupressure
Arm Type
Experimental
Arm Description
The magnetic beads will be taped to the seven pressing points: Hunger point, Ovary, Uterus, Endocrine point, liver, kidney and spleen.
Arm Title
Placebo auricular acupressure
Arm Type
Placebo Comparator
Arm Description
The magnetic beads will be taped to the three pressing points:Tonsil, eye and elbow.
Intervention Type
Other
Intervention Name(s)
Auricular acupressure
Intervention Description
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
Intervention Name(s)
Placebo auricular acupressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body mass index (BMI): BMI change at 3 months.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Oral glucose tolerance test (OGTT)
Time Frame
3 month
Title
Testosterone (T)
Time Frame
3 month
Title
Sex hormone-binding globulin (SHBG)
Time Frame
3 month
Title
Dehydroepiandrosterone sulfate (DHEAS).
Time Frame
3 month
Title
Follicle stimulating hormone (FSH)
Time Frame
3 month
Title
Luteinizing hormone (LH)
Time Frame
3 month
Title
Cholesterol
Time Frame
3 month
Title
Triglycerides (TG)
Time Frame
3 month
Title
Waist/hip ratio
Time Frame
3 month
Title
Ferriman-Gallwey score
Time Frame
3 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Li, Doctor
Phone
+86-451-82111401
Email
liyantcm@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lihui Hou, Bachelor
Organizational Affiliation
First Affiliated Hospital of Heilongjiang University Of Chinese
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lihui Hou, Bachelor
Phone
86-451-82111401
Email
houlihui2007@sina.com

12. IPD Sharing Statement

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

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