search
Back to results

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

Primary Purpose

Polycystic Ovary Syndrome

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Jianpi Qushi Huatan Decoction
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: 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.

Sites / Locations

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

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 in each group during the study period.

Secondary Outcome Measures

Full Information

First Posted
July 27, 2023
Last Updated
September 6, 2023
Sponsor
Jiangxi University of Traditional Chinese Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT05976295
Brief Title
Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome
Official Title
Efficacy of Jianpi Qushi Huatan Decoction in the Treatment of Polycystic Ovary Syndrome: A Randomized Double-blind Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 31, 2023 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

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 (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.

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
68 (Anticipated)

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)
Jianpi Qushi Huatan Decoction
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The control group will receive a placebo treatment.
Primary Outcome Measure Information:
Title
Ovulation rate
Description
Ovulation rate in each group during the study period.
Time Frame
3 months

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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Ruining
Phone
0086-0791-88385243
Email
jack169@sina.com
Facility Information:
Facility Name
The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
City
Nancang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Ruining
Phone
0086-0791-88385243
Email
jack169@sina.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs