NCT02326714

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 29, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

December 20, 2017

Status Verified

December 1, 2017

Enrollment Period

3.6 years

First QC Date

December 11, 2014

Last Update Submit

December 18, 2017

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

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

    3 month

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (2)

Auricular acupressure

EXPERIMENTAL

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

Other: Auricular acupressure

Placebo auricular acupressure

PLACEBO COMPARATOR

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

Other: Placebo auricular acupressure

Interventions

Auricular acupressureOTHER

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.

Auricular acupressure
Placebo auricular acupressureOTHER

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.

Placebo auricular acupressure

Eligibility Criteria

Age12 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women aged between 12 and 25 years.
  • Diagnosis of PCOS according to the modified Rotterdam criteria.
  • years after menarche.
  • Body mass index (BMI) equal to or greater than 23 kg/m\*m.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150040, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Lihui Hou, Bachelor

    First Affiliated Hospital of Heilongjiang University Of Chinese

    STUDY CHAIR

Central Study Contacts

Yan Li, Doctor

CONTACT

+86-451-82111401liyantcm@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate chief physician

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 29, 2014

Study Start

June 1, 2015

Primary Completion

January 1, 2019

Study Completion

June 1, 2019

Last Updated

December 20, 2017

Record last verified: 2017-12

Locations

CN(1)