Back to resultsEfficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome
Primary Purpose
Polycystic Ovary Syndrome
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Bushen Huatan Decoction
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
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.
Sites / Locations
- The Second Affiliated Hospital of Jiangxi University of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Therapy group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Ovulation rate
Ovulation rate in each group during the study period
Secondary Outcome Measures
Full Information
NCT ID
NCT05976308
First Posted
July 27, 2023
Last Updated
September 6, 2023
Sponsor
Jiangxi University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05976308
Brief Title
Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome
Official Title
Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome : a Double-blind, Randomized and Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangxi University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapy group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bushen Huatan Decoction
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The treatment group used Caramel pigment, Ku Ding Cha Extracts, Maltodextrin, Starch and 5% Bushen Huatan Decoction.
Primary Outcome Measure Information:
Title
Ovulation rate
Description
Ovulation rate in each group during the study period
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruining Liang
Phone
0086-0791-88385243
Email
jack169@sina.com
Facility Information:
Facility Name
The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruining Liang
Phone
0086-0791-88385243
Email
jack169@sina.com
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome
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