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Trial Title:
Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome
NCT ID:
NCT05976308
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Bushen Huatan Decoction
Description:
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.
Arm group label:
Therapy group
Intervention type:
Drug
Intervention name:
Placebo
Description:
The treatment group used Caramel pigment, Ku Ding Cha Extracts, Maltodextrin, Starch and
5% Bushen Huatan Decoction.
Arm group label:
Control group
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Address:
City:
Nanchang
Country:
China
Status:
Recruiting
Contact:
Last name:
Ruining Liang
Phone:
0086-0791-88385243
Email:
jack169@sina.com
Start date:
September 1, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Jiangxi University of Traditional Chinese Medicine
Agency class:
Other
Source:
Jiangxi University of Traditional Chinese Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05976308
