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临床试验/CTRI/2025/11/097020
CTRI/2025/11/097020招募中不适用

An Interventional Study on Sensory Evaluation and Analysis of Nutri-balls and its Impact on Haemoglobin Level of Adolescent Girls

Prof Dr Deepa Mishra1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2025年11月18日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
260
试验地点
1
主要终点
Significant increase in haemoglobin level of adolescent girls.

研究概览

简要总结

The proposed study will be conducted in four phases.

  1. At first, Nutri-balls will be prepared by mixing rice flakes and jaggery in two different proportions. Sensory evaluation of the two variations will be done by panel members.
  2. The most acceptable variation obtained through the sensory evaluation process will be selected for interventional purpose and analysed for its nutrient content.
  3. In the next step, data from adolescent girls regarding their haemoglobin level, clinical signs and symptoms, dietary intake, and other associated factors will be collected. Collected data will be analysed and grading of anaemia will be done as per WHO. Moderately and severely anaemic girls but not less than 5g/dl will be selected for interventional purpose and divided into two groups that are trial and control group. Girls of trial group will be provided 2 Nutri-balls(100g approximately) per day for 3 months.
  4. After 3 months, reassessment of haemoglobin level, clinical signs and symptoms, dietary intake of the girls of trial group and control group will be performed.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
15.00 Year(s) 至 19.00 Year(s)(—)
性别
Female

入选标准

  • Willing to participate in the study.

排除标准

  • Adolescent girls suffering from any severe disease conditions, such as known cases of Liver diseases, Renal diseases, Diabetes Mellitus, Haemorrhoids, symptoms like Menorrhagia etc.

结局指标

主要结局

Significant increase in haemoglobin level of adolescent girls.

时间窗: After 3 months of intervention.

次要结局

  • Improvement of signs and symptoms of anaemia in adolescent girls.(After 3 months of intervention.)

研究者

发起方
Prof Dr Deepa Mishra
申办方类型
Other [supervisor]
责任方
Principal Investigator
主要研究者

Prof Dr Deepa Mishra

Banaras Hindu University

研究点 (1)

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