Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome

September 6, 2023 updated by: Ruining Liang, Jiangxi University of Traditional Chinese Medicine

Efficacy of Bushen Huatan Decoction in the Treatment of Polycystic Ovary Syndrome : a Double-blind, Randomized and Placebo-controlled Study

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 (Bushen Huatan Decoction) in women with PCOS.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The diagnosis of PCOS is based on the Rotterdam criteria.
  2. Meet the syndrome differentiation standard of kidney-yang deficiency with phlegm-dampness and blood stasis in TCM theory.
  3. women aged 18-40 years without fertility requirements.
  4. A willingness to undergo this treatment plan.

Exclusion Criteria:

  1. Hyperprolactinemia (2 times serum prolactin levels of more than 25 ng/ml at least one week apart).
  2. Diminished ovarian reserve, FSH (follicle-stimulating hormone) level more than 10 IU/L.
  3. Abnormal thyroid function, TSH (thyroid stimulating hormone) level less than 0.2 mIU/mL or more than 5.5 mIU/mL.
  4. Suspected Cushing's syndrome.
  5. Adrenal or ovarian tumors secreting androgen.
  6. Poorly controlled type II diabetes.
  7. Pregnancy or lactation.
  8. Hypertensive patients with poorly controlled blood pressure (a systolic blood pressure more than 160 mmHg or a diastolic blood pressure more than 100 mmHg).
  9. Those who had taken hormones or other drugs during the previous 3 months.
  10. Acute heart, liver, kidney or blood diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control group
Drug: Placebo
The treatment group used Caramel pigment, Ku Ding Cha Extracts, Maltodextrin, Starch and 5% Bushen Huatan Decoction.
Experimental: Therapy group
Drug: Bushen Huatan Decoction
The treatment group used Bushen Huatan Decoction, including Tusizi (the seed of Chinese dodder), Fupenzi (Raspberry), Bajitian (Morinda officinalis), Duzhong (Eucommia ulmoides), Shudi (prepared Rehmanniaroot), Fuling (Tuckahoe), Zelan (Aconitum gymnandrum), Zexie (Rhizoma alismatis), Guizhi (Cassia twig), Zhebeimu (Thunberg Fritillary Bulb), Taoren (Peach kernel) and Chuanxiong (Ligusticum wallichii). Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovulation rate
Time Frame: 3 months
Ovulation rate in each group during the study period
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangxi University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20223BBG71012-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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