NCT05976308

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 (Bushen Huatan Decoction) in women with PCOS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

July 27, 2023

Last Update Submit

September 6, 2023

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Ovulation rate

    Ovulation rate in each group during the study period

    3 months

Study Arms (2)

Therapy group

EXPERIMENTAL
Drug: Bushen Huatan Decoction

Control group

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Bushen Huatan DecoctionDRUG

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.

Therapy group
PlaceboDRUG

The treatment group used Caramel pigment, Ku Ding Cha Extracts, Maltodextrin, Starch and 5% Bushen Huatan Decoction.

Control group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Central Study Contacts

Ruining Liang

CONTACT

0086-0791-88385243jack169@sina.com

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

July 27, 2023

First Posted

August 4, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

September 8, 2023

Record last verified: 2023-09

Locations

CN(1)