Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome
NCT ID: NCT05976308
Last Updated: 2023-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
68 participants
INTERVENTIONAL
2023-09-01
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Therapy group
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.
Control group
Placebo
The treatment group used Caramel pigment, Ku Ding Cha Extracts, Maltodextrin, Starch and 5% Bushen Huatan Decoction.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
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.
18 Years
40 Years
FEMALE
No
Sponsors
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Jiangxi University of Traditional Chinese Medicine
OTHER
Responsible Party
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Ruining Liang
chief physician
Locations
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The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20223BBG71012-1
Identifier Type: -
Identifier Source: org_study_id
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