Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome

NCT04120597 | Completed Phase 1

• 1 other identifier: S2018ZPYFE0937
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Therapy group

EXPERIMENTAL

Drug: Zishen Qingre Lishi Huayu Granules

Control group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Zishen Qingre Lishi Huayu Granules 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.

Therapy group

Placebo 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.

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Age: 20 to 40 years old, no maternity requirements.
• Willing to be treated according to the treatment plan specified in this study.

You may not qualify if:

• Hyperprolactinemia: In the past year, patients with normal levels can be included.
• Menopausal FSH levels：FSH \> 15 mIU/mL. In the past year, patients with normal levels can be included.
• 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.
• Patients with poorly controlled type 2 diabetes:HbA1c\>7.0%, or patients receiving antidiabetic drugs.
• Patients currently diagnosed with severe anemia (HGB \<10 g/dL).
• Patients with a history of alcohol abuse: Alcohol is defined as drinking 14 times a week or more or binge drinking.
• Currently suspected Cushing's syndrome patients.
• Patients suspected of having adrenal or ovarian tumors secreting androgen.
• 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.
• Patients currently diagnosed with metabolic syndrome
• Take hormonal drugs, Chinese medicine prescriptions and proprietary Chinese medicines in the last 3 months.
• There is a history of pregnancy in the last 6 weeks.
• Abortion or production history in the last 6 weeks.
• A history of breastfeeding in the last 6 months.
• Patients with a history of deep vein thrombosis, pulmonary embolism or cerebrovascular disease.

Sponsors & Collaborators

• Jiangxi University of Traditional Chinese Medicine: lead

Study Sites (1)

The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 9, 2019
• Study Start: December 23, 2019
• Primary Completion: August 20, 2021
• Study Completion: September 6, 2021
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

CN (1)