Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome

Study Overview
=================
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 (Jianpi Qushi Huatan Decoction) in women with PCOS.

Official Title
-----------------
Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Trial

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Jianpi Qushi Huatan Decoction
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The diagnosis of PCOS is based on the Rotterdam criteria. Meet the syndrome differentiation standard of spleen deficiency and phlegm-dampness 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapy group<br> | Drug: Jianpi Qushi Huatan Decoction<br>* 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.<br>|
| Placebo Comparator: Control group<br> | Drug: Placebo<br>* The control group will receive a placebo treatment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovulation rate | Ovulation rate in each group during the study period. | 3 months |