Clinical trial · Interventional
Serum Metabolomics Study of Traditional Chinese Medicine Formula （Shen Qi Tiao Ti Formula） Intervention to Polycystic Ovary Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chinese Medicine Formula | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Chinese Medicine Formula
- description
- All 100 patients were treated with Chinese Medicine Formula(CMF) for three menstrual cycles.
- interventionNames
- Drug: Chinese Medicine Formula
Primary outcomes (1)
- measure
- The fatty acid amides (FAAs) metabolite changes
- timeFrame
- 3 months
- description
- The metabolic changes before and after treatment
Secondary outcomes (1)
- measure
- The sulfated steroids metabolite changes
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 14 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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.
References
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