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
Yan Li
Associate seiner physician
Heilongjiang University of Chinese Medicine
Study Sites (1)
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