Using Bushen Huatan Decoction to treat Polycystic Ovary Syndrome

Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome : a Double-blind, Randomized and Placebo-controlled Study

This study is testing whether a Chinese herbal medicine called Bushen Huatan Decoction can help women with Polycystic Ovary Syndrome feel better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Jiangxi University of Traditional Chinese Medicine (Academic / other)
• Locations: 1 site (Nanchang, Jiangxi)
• Trial ID: NCT05976308 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of Bushen Huatan Decoction, a Chinese herbal medicine, in treating women diagnosed with Polycystic Ovary Syndrome (PCOS) based on the Rotterdam criteria. The study is designed as a randomized double-blind placebo-controlled trial, which means participants will be randomly assigned to receive either the herbal treatment or a placebo without knowing which one they are receiving. The trial aims to provide clearer evidence regarding the effectiveness of this traditional Chinese medicine approach for managing PCOS symptoms. Participants will be women aged 18-40 who meet specific inclusion criteria related to their PCOS diagnosis and overall health.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18-40 diagnosed with PCOS who meet specific traditional Chinese medicine criteria.

Not a fit: Patients with conditions such as hyperprolactinemia, diminished ovarian reserve, or poorly controlled diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for managing symptoms of Polycystic Ovary Syndrome.

How similar studies have performed: While some studies have suggested benefits of Chinese herbal medicine for PCOS, the efficacy of Bushen Huatan Decoction specifically remains unclear, making this approach somewhat novel.

Eligibility criteria

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.

Where this trial is running

Nanchang, Jiangxi

• The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine — Nanchang, Jiangxi, China (Recruiting)

Study contacts

• Study coordinator: Ruining Liang

Conditions Polycystic Ovary Syndrome