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Trial record 99 of 566 for:    "Polycystic Ovary Syndrome"

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

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ClinicalTrials.gov Identifier: NCT02326714
Recruitment Status : Recruiting
First Posted : December 29, 2014
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Yan Li, Heilongjiang University of Chinese Medicine

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Body mass index (BMI): BMI change at 3 months. [ Time Frame: 3 month ]

Secondary Outcome Measures :
  1. Oral glucose tolerance test (OGTT) [ Time Frame: 3 month ]
  2. Testosterone (T) [ Time Frame: 3 month ]
  3. Sex hormone-binding globulin (SHBG) [ Time Frame: 3 month ]
  4. Dehydroepiandrosterone sulfate (DHEAS). [ Time Frame: 3 month ]
  5. Follicle stimulating hormone (FSH) [ Time Frame: 3 month ]
  6. Luteinizing hormone (LH) [ Time Frame: 3 month ]
  7. Cholesterol [ Time Frame: 3 month ]
  8. Triglycerides (TG) [ Time Frame: 3 month ]
  9. Waist/hip ratio [ Time Frame: 3 month ]
  10. Ferriman-Gallwey score [ Time Frame: 3 month ]


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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326714


Contacts
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Contact: Yan Li, Doctor +86-451-82111401 liyantcm@163.com

Locations
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China, Heilongjiang
First Affiliated Hospital, Heilongjiang University of Chinese Medicine Recruiting
Harbin, Heilongjiang, China, 150040
Contact: Lihui Hou, Bachelor    86-451-82111401    houlihui2007@sina.com   
Sponsors and Collaborators
Heilongjiang University of Chinese Medicine
Investigators
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Study Chair: Lihui Hou, Bachelor First Affiliated Hospital of Heilongjiang University Of Chinese

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Responsible Party: Yan Li, Associate chief physician, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT02326714     History of Changes
Other Study ID Numbers: AA for PCOS
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Overweight
Disease
Pathologic Processes
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases