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Clinical Trials/NCT02608554
NCT02608554UnknownNot Applicable

Taichi for Treating Overweight/Obese Adolescent and Young Women With Polycystic Ovary Syndrome (PCOS)

Heilongjiang University of Chinese Medicine1 site in 1 country50 target enrollmentStarted: October 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Body mass index (BMI)

Study Overview

Brief Summary

The present study is a randomized pilot study, overweight/obese adolescent and young PCOS subjects will be assigned into two groups: Taichi arm and control arm. Hormonal profile and metabolic profile will be determined.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Women aged between 19 and 35 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 disorder including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.
  • Patients with known severe organ dysfunction or mental illness.

Outcomes

Primary Outcomes

Body mass index (BMI)

Time Frame: 3 months

Secondary Outcomes

  • Follicle stimulating hormone (FSH)(3 months)
  • Testosterone (T)(3 months)
  • Fasting plasma glucose (Glu)(3 months)
  • Fasting insulin (Ins)(3 months)
  • HOMA-IR(3 months)
  • Ferriman-Gallwey score(3 months)
  • Luteinizing hormone (LH)(3 months)
  • Waist/hip ratio(3 months)

Investigators

Sponsor
Heilongjiang University of Chinese Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yan Li

Associate seiner physician

Heilongjiang University of Chinese Medicine

Study Sites (1)

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