跳至主要内容
临床试验/CTRI/2025/07/091006
CTRI/2025/07/091006尚未招募不适用

Transdermal Iron Supplementation as Bindi for Women: A Novel Concept

IIT Bhilai Innovation and Technology Foundation4 个研究点 分布在 1 个国家目标入组 520 人开始时间: 2025年9月1日最近更新:

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

发起方
IIT Bhilai Innovation and Technology Foundation
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr Ruchita Dixit

Shri Shankaracharya Institute of Medical Sciences

研究点 (4)

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