Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome

NCT ID: NCT04120597

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-23
• Study Completion Date: 2021-09-06

Brief 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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Therapy group

Group Type: EXPERIMENTAL

Zishen Qingre Lishi Huayu Granules

Intervention Type: DRUG

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.

Control group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Ruining Liang

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

S2018ZPYFE0937

Identifier Type: -

Identifier Source: org_study_id