Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05976308
• Other study ID #: 20223BBG71012-1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: September 2023
• Source: Jiangxi University of Traditional Chinese Medicine
• Contact: Ruining Liang
• Phone: 0086-0791-88385243
• Email: jack169[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Bushen 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.
• Placebo
The treatment group used Caramel pigment, Ku Ding Cha Extracts, Maltodextrin, Starch and 5% Bushen Huatan Decoction.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation rate	Ovulation rate in each group during the study period	3 months