Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

Clinical and Basic Research on the Treatment of Zishen Qingre Lishi Huayu Method on Zin Deficiency and Dampness Type Polycystic Ovary Syndrome: a Multi-center, Double-blind, Randomized and Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120597
• Other study ID #: S2018ZPYFE0937
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 23, 2019
• Est. completion date: September 6, 2021

Study information

• Verified date: July 2023
• Source: Jiangxi University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Polycystic ovary syndrome is the most common endocrine and metabolic disorder in gynecology. Traditional Chinese medicine has a good clinical effect in the treatment of PCOS. We intend to conduct this trial in strict accordance with the requirements of evidence-based medicine, through a multi-center, randomized, controlled study, using a double-blind, randomized, placebo-controlled study design method to clarify that Zishen Qingre Lishi Huayu Recipe restores spontaneous ovulation in PCOS patients. The overall efficacy of improving the characteristics of Kaohsiung and glucose and lipid metabolism is optimal, and high-level evidence-based evidence is obtained to form a diagnosis and treatment plan for promotion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 6, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Diagnosed as PCOS patients, the diagnostic criteria is: modify the Rotterdam criteria. All subjects must have: no ovulation, combined with polycystic ovarian or / and hyperandrogenism.

2. Age: 20 to 40 years old, no maternity requirements.

3. Willing to be treated according to the treatment plan specified in this study.

Exclusion Criteria:

1. Hyperprolactinemia: In the past year, patients with normal levels can be included.

2. Menopausal FSH levels:FSH > 15 mIU/mL. In the past year, patients with normal levels can be included.

3. Patients with thyroid disease: TSH < 0.2 mIU/mL or >5.5 mIU/mL. In the past year, patients with normal levels can be included.

4. Patients with poorly controlled type 2 diabetes:HbA1c>7.0%, or patients receiving antidiabetic drugs.

5. Patients currently diagnosed with severe anemia (HGB <10 g/dL).

6. Patients with a history of alcohol abuse: Alcohol is defined as drinking 14 times a week or more or binge drinking.

7. Currently suspected Cushing's syndrome patients.

8. Patients suspected of having adrenal or ovarian tumors secreting androgen.

9. In patients with hypertension who are currently untreated or have poor blood pressure control, the interval between two blood pressure measurements is = 60 min, systolic blood pressure = 160 mm Hg or diastolic blood pressure = 100 mm Hg.

10. Patients currently diagnosed with metabolic syndrome

11. Take hormonal drugs, Chinese medicine prescriptions and proprietary Chinese medicines in the last 3 months.

12. There is a history of pregnancy in the last 6 weeks.

13. Abortion or production history in the last 6 weeks.

14. A history of breastfeeding in the last 6 months.

15. Patients with a history of deep vein thrombosis, pulmonary embolism or cerebrovascular disease.

16. Patients with severe primary diseases such as cardiovascular, liver, kidney and hematopoietic system, and mental patients

17. Patients who are expected to discontinue treatment during the trial or who are unable to adhere to treatment for 3 months should be excluded.

18. Reluctant to sign the informed consent form for this study.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Zishen Qingre Lishi Huayu Granules
The treatment group used Zishen Qingre Lishi Huayu Granules, including Zhimu(Anemarrhena asphodeloides Bge.), Shengdi(Rehmannia glutinosa Libosch.), Maidong(Ophio pogon japonicus (L.f) KerGawl.) , Bixie(Dioscorea septemloma Thunb.), Huanglian(Coptis chinensis Franch.), Zhuling(Polyporus umbellatus(Pers.)Fries), Xuanshen(Scrophularia ningpoensis Hemsl.), Zelan(Lycopus lucidus Turcz. Var. Hirtus Regel), Danshen(Salvia miltiorrhiza Beg.), Gancao(Glycyrrhiza uralensis Fisch.). 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% Zishen Qingre Lishi Huayu Granules . Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation rate	Ovulation rate of each group during the study period Ovulation rate per group = actual total ovulation frequency / total number of cycles (total number of cycles = number of samples).	The 3rd month