Transdermal Iron Supplementation as Bindi for Women: A Novel Concept
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 520
- 试验地点
- 4
- 主要终点
- Overall reducing mortality and morbidity
研究概览
简要总结
Title: Transdermal Iron Supplementation as Bindi for Women A Novel Concept
Objective: To develop and evaluate the effectiveness of transdermal iron supplementation through a bindi a colored sticker dot worn on the forehead for women
Methodology:
- Laboratory experiments to identify the best iron salt and dosage for transdermal absorption
- Preclinical trials on animal models to assess safety and efficacy
- Phase I clinical trial on 35 healthy women to assess safety and tolerability
- Phase II clinical trial on 175 women with iron deficiency anemia to assess efficacy
- Phase III randomized controlled trial on 310 women with iron deficiency anemia to confirm efficacy and safety
- Phase IV postmarketing trial to assess longterm safety and effectiveness
Expected Outcomes:
- Development of an effective and safe transdermal iron supplementation method
- Reducing hospital admission and hospital stays due to iron deficiency anemia in women
- Reducing the burden on the healthcare system
- Overall reducing mortality and morbidity
- Improving the health of the community
- Better productivity
- Providing quality services to women
Significance: Iron deficiency anemia is a significant public health concern affecting millions of women worldwide. This novel approach offers a convenient noninvasive and potentially more effective solution.
Timeline: 1 year 6 months
Funding: 5 lakh rupees
Resources available: Researchers laboratory staff clinical trial participants tertiary care hospital rural health training centre and pharmaceutical laboratory facilities
Keywords: Bindi Iron Supplementation Novel approach Anemia Transdermal patch Clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •1.women in reproductive age group, with and without Iron deficiency anemia 2.who give consent for the trial.
排除标准
- •1.Women seriously ill
- •Pregnant women
- •Not giving consent.
结局指标
主要结局
Overall reducing mortality and morbidity
时间窗: continous ongoing
Improving the health of the community
时间窗: continous ongoing
Better productivity
时间窗: continous ongoing
Providing quality services to women
时间窗: continous ongoing
Reducing the burden on the healthcare system
时间窗: continous ongoing
Development of an effective and safe transdermal iron supplementation method
时间窗: continous ongoing
Reducing hospital admission and hospital stays due to iron deficiency anemia in women
时间窗: continous ongoing
次要结局
未报告次要终点
研究者
Dr Ruchita Dixit
Shri Shankaracharya Institute of Medical Sciences
