Using Jianpi Qushi Huatan Decoction to treat Polycystic Ovary Syndrome

Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Trial

This study is testing if a Chinese herbal medicine called Jianpi Qushi Huatan Decoction can help women with Polycystic Ovary Syndrome feel better compared to a placebo.

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 (Nancang, Jiangxi)
• Trial ID: NCT05976295 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of Jianpi Qushi Huatan Decoction, a Chinese herbal medicine, in treating women diagnosed with Polycystic Ovary Syndrome (PCOS). It is a randomized, double-blind, placebo-controlled trial designed to provide clearer evidence regarding the benefits of this herbal treatment. Participants will be women aged 18-40 who meet specific criteria related to PCOS and traditional Chinese medicine syndromes. The study aims to gather data on the effectiveness of this herbal approach compared to a placebo.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-40 diagnosed with PCOS according to the Rotterdam criteria and who exhibit specific traditional Chinese medicine syndromes.

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 this specific decoction remains to be clearly established.

Eligibility criteria

Inclusion Criteria:

1. The diagnosis of PCOS is based on the Rotterdam criteria.
2. Meet the syndrome differentiation standard of spleen deficiency and phlegm-dampness 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

Nancang, Jiangxi

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

Study contacts

• Study coordinator: Liang Ruining

Conditions Polycystic Ovary Syndrome