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

Sponsor

Jiangxi University of Traditional Chinese Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT05976308

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Bushen Huatan Decoction Drug: Placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Therapy group	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 Comparator: Control group	Drug: Placebo The treatment group used Caramel pigment, Ku Ding Cha Extracts, Maltodextrin, Starch and 5% Bushen Huatan Decoction.

Arm

Intervention/Treatment

Experimental: Therapy group

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 Comparator: Control group

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Ovulation rate [3 months]
Ovulation rate in each group during the study period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

The diagnosis of PCOS is based on the Rotterdam criteria.
Meet the syndrome differentiation standard of kidney-yang deficiency with phlegm-dampness and blood stasis in TCM theory.
women aged 18-40 years without fertility requirements.
A willingness to undergo this treatment plan.

Exclusion Criteria:

Hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least one week apart).
Diminished ovarian reserve, FSH (follicle-stimulating hormone) level more than 10 IU/L.
Abnormal thyroid function, TSH (thyroid stimulating hormone) level less than 0.2 mIU/mL or more than 5.5 mIU/mL.
Suspected Cushing's syndrome.
Adrenal or ovarian tumors secreting androgen.
Poorly controlled type II diabetes.
Pregnancy or lactation.
Hypertensive patients with poorly controlled blood pressure (a systolic blood pressure more than 160 mmHg or a diastolic blood pressure more than 100 mmHg).
Those who had taken hormones or other drugs during the previous 3 months.
Acute heart, liver, kidney or blood diseases.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine	Nanchang	Jiangxi	China

Sponsors and Collaborators

Jiangxi University of Traditional Chinese Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ruining Liang, chief physician, Jiangxi University of Traditional Chinese Medicine

ClinicalTrials.gov Identifier:

NCT05976308

Other Study ID Numbers:

20223BBG71012-1

First Posted:

Aug 4, 2023

Last Update Posted:

Aug 7, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Study Results

No Results Posted as of Aug 7, 2023