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

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ClinicalTrials.gov Identifier: NCT03623451
Recruitment Status : Unknown
Verified February 2020 by Yan Li, Heilongjiang University of Chinese Medicine.
Recruitment status was:  Active, not recruiting
First Posted : August 9, 2018
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Yan Li, Heilongjiang University of Chinese Medicine

Tracking Information
First Submitted Date  ICMJE August 6, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date February 18, 2020
Actual Study Start Date  ICMJE August 10, 2018
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
The fatty acid amides (FAAs) metabolite changes [ Time Frame: 3 months ]
The metabolic changes before and after treatment
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
The fatty acid amides (FAAs) metabolite changes [ Time Frame: 6 months ]
The metabolic changes before and after treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
The sulfated steroids metabolite changes [ Time Frame: 3 months ]
The metabolic changes before and after treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
The sulfated steroids metabolite changes [ Time Frame: 6 months ]
The metabolic changes before and after treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Serum Metabolomics Study of Traditional Chinese Medicine Formula (Shen Qi Tiao Ti Formula) Intervention to Polycystic Ovary Syndrome
Official Title  ICMJE Serum Metabolomics Study of Traditional Chinese Medicine Formula (Shen Qi Tiao Ti Formula) Intervention to Polycystic Ovary Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Ovary Syndrome
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Chinese Medicine Formula
All 100 patients were treated with Chinese Medicine Formula(CMF) for three menstrual cycles.
Intervention: Drug: Chinese Medicine Formula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: February 14, 2020)
105
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2018)
100
Estimated Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03623451
Other Study ID Numbers  ICMJE Shen Qi Tiao Ti_PCOS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Yan Li, Heilongjiang University of Chinese Medicine
Original Responsible Party Yan Li, Heilongjiang University of Chinese Medicine, Doctor
Current Study Sponsor  ICMJE Heilongjiang University of Chinese Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Heilongjiang University of Chinese Medicine
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP