CTRI/2024/03/064022招募中3 期
A randomized double-blind, placebo-controlled, parallel multicenter phase III study to evaluate the effectiveness and safety of Probiotic IND 2-A and IND 2-B Blends of strains VHBSUB, VHBCSI, VHBAX on the clinical and biological parameters of reproductive-aged PCOS women - NI
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Diagnosed PCOS defined as 2003 Rotterdam diagnostic criteria (the presence of antral follicle count (AFC) of 12 or more and or an ovarian volume greater than 10 mL).
- •2.Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF).
- •3.Willingness and capability to complete all the study procedures.
排除标准
- •During the pregnancy and lactation period.
- •Significant impaired liver function, impaired renal function, mental disease, severe infection, severe anemia, severe heart disease and neutropenia disease.
- •Use of antibiotics within 3 months.
- •Symptoms of any infection at screening.
- •Immunodeficient or use of immunosuppressive drugs.
- •Use of products containing prebiotics or probiotics within the last 3 months.
- •Previous history of gastrointestinal surgery or disease (such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease or other gastrointestinal disorder).
- •Medical conditions or diseases that may affect subject safety or confound study results in the opinion of the investigator
研究者
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