A Single Arm, Open-label Study of the Efficacy of Minayo Iron-rich Yeast Drink With SOD on Female Nutritional Anemia, Skin Condition and Qi-blood Deficiency Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change of Serum Ferritin Level
研究概览
简要总结
The goal of this single arm, open-label study is to learn about the efficacy of Minayo Iron-rich Yeast Drink with SOD on females who are aged 18-35 and suffer nutritional Anemia, skin condition and Qi-blood deficiency syndrome. The main question it aims to answer is:
- whether the serum ferritin level in blood is improved after the intervention
14 qualified participants will be enrolled to drink the product "Minayo Iron-rich Yeast Drink with SOD" for four weeks, once a day. Four site visits will be made for each participant so that all relevant clinical data will be captured and recorded for data analysis and reporting.
Researchers will compare the final blood test result (hemoglobin concentration level, Glutathione (GSH), Superoxide Dismutase (SOD)) against the baseline to conclude whether the product will be effective in improving Anemia and skin conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, aged 18 to 35;
- •Hemoglobin concentration level below 110g/L based on WHO diagnostic criteria for anemia;
- •Agree not to take any drugs, supplements, or other dairy products during the trial;
- •Agree not to take any other medications or supplements containing iron during the trial;
- •Willing to refrain from participating in other interventional clinical studies during the trial period;
- •Be able to fully understand the purpose, benefits and potential risks including side effects of the research;
- •Willing to obey all test requirements and procedures;
- •Informed consent signed.
排除标准
- •Anemia caused by organic diseases;
- •Subject who is in the treatment of gastrointestinal symptoms;
- •Lactose intolerance;
- •Subject who is currently presence of other organic diseases affecting intestinal function, such as history of gastrointestinal resection, colon or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, congenital megacolon, scleroderma, anorexia nervosa, etc.;
- •Controlling diet, exercising, or taking medications to control weight or affect appetite in the last 3 months;
- •Subject who has any of the following medical history or clinical findings that may affect the evaluation of the trial effect: significant gastrointestinal disorders, liver, kidney, endocrine, hematological, respiratory and cardiovascular diseases;
- •Abuse alcohol or other drugs, supplement or OTC drugs currently or n the past may cause bowel dysfunction or can affect test result evaluation;
- •Frequently use of medications that may affect gastrointestinal function or the immune system according to investigator's judgment;
- •Take laxatives or other substances that promote digestion 2 weeks before the trail start;
- •Subject who used drugs or supplements of iron agent 10 days before the beginning of the trial;
- •Pregnant or lactating women or those planning to become pregnant during the trial;
- •PI deems that subjects could not fully cooperate with trial arrangements.
结局指标
主要结局
Change of Serum Ferritin Level
时间窗: baseline day, end of week 4
The change of serum ferritin level in blood, ng/mL (12\~135ng/mL for healthy female, 27\~375ng/mL for healthy male)
次要结局
- Superoxide Dismutase (SOD) Concentration Level(baseline day, end of week 4)
- Glutathione (GSH) Concentration Level(baseline day, end of week 4)
- Skincare Measurement - Lines/Wrinkles(baseline day, end of week 4)
- Hemoglobin Concentration Level(baseline day, end of week 4)