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临床试验/NCT05657821
NCT05657821招募中早期 1 期

THE EFFECT OF PUMPKIN SEED EXTRACT CAPSULES (Cucurbita Moschata Durch) ON NUTRITIONAL STATUS AND HAEMOGLOBIN LEVEL IN PREGNANT WOMEN TO PREVENTION STUNTING ; A PROTOCOL OF RANDOMIZED CONTROLLED TRIAL STUDY

Dr. Rosdiana Syakur2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年10月25日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
招募中
发起方
入组人数
70
试验地点
2
主要终点
Nutritional status

研究概览

简要总结

The goal of this to measure the effect of supplementation of Yellow Pumpkin Seed Extract Capsules in pregnant women on hemoglobin levels and nutritional status of pregnant women.

The main question[s] it aims to answer are:

  • is there a difference in changes in nutritional status (increase in body weight and MUAC) in pregnant women who receive supplementation of Pumpkin Seed Extract Capsules and iron tablets
  • is there a difference in changes in hemoglobin levels in pregnant women who receive supplementation of Pumpkin Seed Extract Capsules and iron tablets.

The research sample was divided into two groups, namely the intervention group and the control group. In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks, while the control group received iron tablets for 12 weeks as well. Measurements of nutritional status (including measurements of body weight and Mid Upper Arm Circumference/MUAC) were carried out before and after the intervention and were monitored every month until 12 weeks when the intervention was carried out. As for measuring blood hemoglobin levels, it was taken before the intervention and after the intervention for 12 weeks

详细描述

This study was designed with an experimental method using a randomized double blind with a control group. The research sample was divided into two groups, namely the intervention group and the control group. In the intervention group, pregnant women received pumpkin seed extract capsules for 12 weeks, while the control group received iron tablets for 12 weeks as well. Measurements of nutritional status (including measurements of body weight and Mid Upper Arm Circumference/MUAC) were carried out before and after the intervention and were monitored every month until 12 weeks when the intervention was carried out. As for measuring blood hemoglobin levels, it was taken before the intervention and after the intervention for 12 weeks. The research will be conducted in the village of the stunting locus, Bone Regency, South Sulawesi, Indonesia. Data analysis was carried out with SPSS, where to see the difference between the intervention group and the contro group, a paired t test was used if the data was normally distributed and an alternative test if the data was not normally distributed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
17 Years 至 39 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • in the one or second trimester of pregnancy;
  • having no complications;
  • willing to participate in this study;
  • domiciled in the stunting locus village Bone regency .

排除标准

  • Pregnant women with complications

结局指标

主要结局

Nutritional status

时间窗: 12 weeks

measurements of body weight and Mid Upper Arm Circumference/MUAC) were carried out before and after the intervention and were monitored every month until 12 weeks when the intervention was carried out

hemoglobin levels

时间窗: 12 weeks

Hemoglobin level in the blood is measured by taking blood from the fingertip. Then measured using the digital strip method.

次要结局

未报告次要终点

研究者

发起方
Dr. Rosdiana Syakur
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Rosdiana Syakur

Indonesia Timur University

Indonesia Timur University

研究点 (2)

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