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

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chinese Medicine Formula
Sponsored by
Heilongjiang University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

14 Years - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chinese Medicine Formula

Arm Description

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

Outcomes

Primary Outcome Measures

The fatty acid amides (FAAs) metabolite changes
The metabolic changes before and after treatment

Secondary Outcome Measures

The sulfated steroids metabolite changes
The metabolic changes before and after treatment

Full Information

First Posted
August 6, 2018
Last Updated
February 14, 2020
Sponsor
Heilongjiang University of Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03623451
Brief Title
Serum Metabolomics Study of Traditional Chinese Medicine Formula （Shen Qi Tiao Ti Formula） Intervention to Polycystic Ovary Syndrome
Official Title
Serum Metabolomics Study of Traditional Chinese Medicine Formula （Shen Qi Tiao Ti Formula） Intervention to Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heilongjiang University of Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chinese Medicine Formula
Arm Type
Experimental
Arm Description
All 100 patients were treated with Chinese Medicine Formula(CMF) for three menstrual cycles.
Intervention Type
Drug
Intervention Name(s)
Chinese Medicine Formula
Intervention Description
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.
Primary Outcome Measure Information:
Title
The fatty acid amides (FAAs) metabolite changes
Description
The metabolic changes before and after treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The sulfated steroids metabolite changes
Description
The metabolic changes before and after treatment
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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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