NCT03623451

Brief Summary

Polycystic ovary syndrome (PCOS) is a most common, heterogeneous, complex endocrinopathy disease.Traditional Chinese medicine (TCM) has been used in the treatment of PCOS for many years. However, the mechanism underlying TCM remains obscure and challenging.In the present study, a metabolomics approach based on ultra-high-performance liquid chromatography (UPLC) coupled with linear ion trap Orbi-trap mass spectrometer (LTQ Orbi-trap MS) is used to investigate serum metabolic changes of TCM intervention to 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
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable

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

August 6, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

August 10, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

August 6, 2018

Last Update Submit

February 14, 2020

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • The fatty acid amides (FAAs) metabolite changes

    The metabolic changes before and after treatment

    3 months

Secondary Outcomes (1)

  • The sulfated steroids metabolite changes

    3 months

Study Arms (1)

Chinese Medicine Formula

EXPERIMENTAL

All 100 patients were treated with Chinese Medicine Formula(CMF) for three menstrual cycles.

Drug: Chinese Medicine Formula

Interventions

Chinese Medicine FormulaDRUG

Chinese Medicine Formula, composed of American ginseng 10g, Poria cocos 15g, bighead atractylodes rhizome 20g, Astragalus mongholicus 30g, Crataegus pinnatifida Bunge 20g, Salvia miltiorrhiza Bge. 20g, Pericarpium Citri Reticulatae 10g will be decocted and packaged into vacuum packs by the pharmaceutical department of First Affiliated Hospital, Heilongjiang University of Chinese Medicine (140 mL/pack). Subjects will take 2 packages per day for three months.

Chinese Medicine Formula

Eligibility Criteria

Age14 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • PCOS diagnostic criteria: According to the diagnostic criteria revised by the European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine at the Rotterdam in 2003, PCOS patients can be diagnosed if two of the three criteria are present after excluding congenial adrenal hyperplasia, Cushing's syndrome, androgen secreting tumors, or other related disorders. The three criteria are (1) oligo- and/or anovulation; (2) clinical and/or biochemical signs of hyperandrogenism (clinical manifestations of hyperandrogenism include presence of acne, hirsutism, and androgenic alopecia); (3) polycystic ovaries by ultrasound examination: presence of 12 or more follicles in each ovary measuring 2-9 mm on diameter and/or ovarian volume\>10 ml.
  • Age between 14 and 40 years.
  • years after menarche

You may not qualify if:

  • Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers.
  • Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.
  • Patients with known severe organ dysfunction or mental illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150040, China

Location

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

August 6, 2018

First Posted

August 9, 2018

Study Start

August 10, 2018

Primary Completion

August 31, 2019

Study Completion

June 30, 2020

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations

CN(1)