Clincosm LogoSign in Get a demo

Serum Metabolomics Study of Traditional Chinese Medicine Formula （Shen Qi Tiao Ti Formula） Intervention to Polycystic Ovary Syndrome

Sponsor
Heilongjiang University of Chinese Medicine (Other)
Overall Status
Unknown status
CT.gov ID
NCT03623451
Collaborator
(none)
105
Enrollment
1
Location
1
Arm
22.7
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chinese Medicine Formula
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Serum Metabolomics Study of Traditional Chinese Medicine Formula （Shen Qi Tiao Ti Formula） Intervention to Polycystic Ovary Syndrome
Actual Study Start Date :
Aug 10, 2018
Actual Primary Completion Date :
Aug 31, 2019
Anticipated Study Completion Date :
Jun 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Chinese Medicine Formula

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

Drug: Chinese Medicine Formula
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.

Outcome Measures

Primary Outcome Measures

  1. The fatty acid amides (FAAs) metabolite changes [3 months]

    The metabolic changes before and after treatment

Secondary Outcome Measures

  1. The sulfated steroids metabolite changes [3 months]

    The metabolic changes before and after treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 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.

  • 2 years after menarche

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Affiliated Hospital, Heilongjiang University of Chinese Medicine Harbin Heilongjiang China 150040

Sponsors and Collaborators

  • Heilongjiang University of Chinese Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yan Li, Clinical professor, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier:
NCT03623451
Other Study ID Numbers:
  • Shen Qi Tiao Ti_PCOS
First Posted:
Aug 9, 2018
Last Update Posted:
Feb 18, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Syndrome

Study Results

No Results Posted as of Feb 18, 2020