Polycystic Ovary Syndrome
Conditions
Brief summary
Polycystic ovary syndrome (PCOS) is a common reproductive disease associated with endocrine and metabolic disorders. Some studies have shown that Chinese herbal medicine is beneficial for PCOS, but the efficacy of Chinese herbal medicine in the treatment of PCOS is not clear, because the quantity of pre-clinical data was limited and the quality of clinical evidence was variable. Therefore, this randomized double-blind placebo-controlled trial aim to evaluate the efficacy of Chinese herbal medicine (Bushen Huatan Decoction) in women with PCOS.
Interventions
DRUGBushen Huatan Decoction
The treatment group used Bushen Huatan Decoction, including Tusizi (the seed of Chinese dodder), Fupenzi (Raspberry), Bajitian (Morinda officinalis), Duzhong (Eucommia ulmoides), Shudi (prepared Rehmanniaroot), Fuling (Tuckahoe), Zelan (Aconitum gymnandrum), Zexie (Rhizoma alismatis), Guizhi (Cassia twig), Zhebeimu (Thunberg Fritillary Bulb), Taoren (Peach kernel) and Chuanxiong (Ligusticum wallichii). Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.
DRUGPlacebo
The treatment group used Caramel pigment, Ku Ding Cha Extracts, Maltodextrin, Starch and 5% Bushen Huatan Decoction.
Sponsors
Jiangxi University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. The diagnosis of PCOS is based on the Rotterdam criteria. 2. Meet the syndrome differentiation standard of kidney-yang deficiency with phlegm-dampness and blood stasis in TCM theory. 3. women aged 18-40 years without fertility requirements. 4. A willingness to undergo this treatment plan.
Exclusion criteria
1. Hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least one week apart). 2. Diminished ovarian reserve, FSH (follicle-stimulating hormone) level more than 10 IU/L. 3. Abnormal thyroid function, TSH (thyroid stimulating hormone) level less than 0.2 mIU/mL or more than 5.5 mIU/mL. 4. Suspected Cushing's syndrome. 5. Adrenal or ovarian tumors secreting androgen. 6. Poorly controlled type II diabetes. 7. Pregnancy or lactation. 8. Hypertensive patients with poorly controlled blood pressure (a systolic blood pressure more than 160 mmHg or a diastolic blood pressure more than 100 mmHg). 9. Those who had taken hormones or other drugs during the previous 3 months. 10. Acute heart, liver, kidney or blood diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovulation rate | 3 months | Ovulation rate in each group during the study period |
Countries
China
Contacts
Primary ContactRuining Liang
Outcome results
None listed