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
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Condition or disease | Intervention/treatment | Phase |
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Polycystic Ovary Syndrome | Drug: Chinese Medicine Formula | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
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 : | August 10, 2018 |
Actual Primary Completion Date : | August 31, 2019 |
Estimated Study Completion Date : | June 30, 2020 |

Arm | Intervention/treatment |
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Experimental: Chinese Medicine Formula
All 100 patients were treated with Chinese Medicine Formula(CMF) for three menstrual cycles.
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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. |
- The fatty acid amides (FAAs) metabolite changes [ Time Frame: 3 months ]The metabolic changes before and after treatment
- The sulfated steroids metabolite changes [ Time Frame: 3 months ]The metabolic changes before and after treatment

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Ages Eligible for Study: | 14 Years to 40 Years (Child, Adult) |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623451
China, Heilongjiang | |
First Affiliated Hospital, Heilongjiang University of Chinese Medicine | |
Harbin, Heilongjiang, China, 150040 |
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: | August 9, 2018 Key Record Dates |
Last Update Posted: | February 18, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Polycystic Ovary Syndrome Syndrome Disease Pathologic Processes Ovarian Cysts Cysts |
Neoplasms Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases |