ACTRN12622001337763招募中未知
The Potential Benefits of Ginger Supplementation in Individuals With Iron Deficiency: a Randomised Controlled Pilot Study
The Oaks Medical Practice0 个研究点目标入组 20 人开始时间: 2022年10月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Adults aged 18 and over
- •2. Confirmed iron deficiency (ID) diagnosis with SF level less than 30 µg/L with normal or slightly lower than normal Hb level (Hb greater than or equal to 110 g/L)
- •3. Adequately maintained liver and renal functions with the following laboratory
- •parameters less than 2x Upper Limit of Normal:
- •a. Alanine transaminase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT)
- •b. Blood urea nitrogen (BUN) and creatinine
- •4. Functional grade based on ECOG Performance Status is between 0 to 2
- •5. Received explanation of the purpose and methods of the study and provided written
- •consent at the point of recruitment
排除标准
- •1. A mental health condition that may impede the patient’s ability to provide informed consent
- •2. Having diagnosed with an eating disorder or demonstrating certain behavioural, physical and psychological signs or changes that often accompany an eating disorder
- •3. Known or possible pregnancy, desire to become pregnant during the study period, or currently breastfeeding
- •4. Known to have an allergy to ginger or had experienced adverse reactions to ginger previously
- •5. Underwent any major surgery within 6 months at the time of screening or planning to undergo a major surgery during the study period
- •6. Had any blood transfusion to replace blood lost due to surgery or injury within the last 6 months or need to receive a blood transfusion during the study period
- •7. Having underlying pathology and sources of overt and occult blood loss (e.g., GIT, genitourinary, nose, mouth, etc.) that was diagnosed or currently under investigation
- •8. Donating blood within 8 weeks of starting the trial or during the study period
- •9. Having underlying conditions due to chronic disease (e.g. inflammatory bowel disease, celiac disease, autoimmune gastritis, rheumatoid arthritis, etc.), liver disease, B12 deficiency, or malignancy
- •10. Having active infections or other medical conditions that elevate SF and high sensitivity C-reactive protein (hsCRP) acutely
- •11. Previous treatment of ID with oral iron therapy within the last 1 month or intravenous iron therapy within the last 3 months
- •12. Currently on warfarin or any other blood-thinning medications (anticoagulants)
- •13. No concurrently taking other dietary supplement of iron, vitamin C, probiotics, vitamin B12, folic acid, and vitamin D during the trial
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