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Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Zishen Qingre Lishi Huayu Granules
Placebo
Sponsored by
Jiangxi University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Therapy group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 29, 2019
Last Updated
July 14, 2023
Sponsor
Jiangxi University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04120597
Brief Title
Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 23, 2019 (Actual)
Primary Completion Date
August 20, 2021 (Actual)
Study Completion Date
September 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangxi University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapy group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Zishen Qingre Lishi Huayu Granules
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ovulation rate
Description
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).
Time Frame
The 3rd month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Patients with severe primary diseases such as cardiovascular, liver, kidney and hematopoietic system, and mental patients Patients who are expected to discontinue treatment during the trial or who are unable to adhere to treatment for 3 months should be excluded. Reluctant to sign the informed consent form for this study.
Facility Information:
Facility Name
The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
City
Nanchang
State/Province
Jiangxi
Country
China

12. IPD Sharing Statement

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Clinical and Basic Research on the Treatment of Polycystic Ovary Syndrome

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