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Trial Title:
Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome
NCT ID:
NCT05976295
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:
Jianpi Qushi Huatan Decoction
Description:
The treatment group will receive the Jianpi Qushi Huatan Decoction (consisting of Radix
astragali, Atractylodes Lancea, Dioscorea oppositifolia, Cyperus rotundus, Lindera
aggregata, Aconitum gymnandrum and Ligusticum wallichii, among others). Subjects will
take the medication from the first day of inclusion, dissolving and consuming one packet
twice a day (morning and evening) for a total of three months.
Arm group label:
Therapy group
Intervention type:
Drug
Intervention name:
Placebo
Description:
The control group will receive a placebo treatment.
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 (Jianpi
Qushi 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 spleen deficiency and phlegm-dampness
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:
Nancang
Country:
China
Status:
Recruiting
Contact:
Last name:
Liang Ruining
Phone:
0086-0791-88385243
Email:
jack169@sina.com
Start date:
August 31, 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/NCT05976295
