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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-10

Study Completion Date

2020-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chinese Medicine Formula

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

Group Type EXPERIMENTAL

Chinese Medicine Formula

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

14 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No