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临床试验/NCT03065595
NCT03065595已完成4 期

The Effect of Ophicephalus Striatus Extract on Levels of Insulin-like Growth Factor-1 (IGF-1), Albumin, and Mini Nutritional Assessment Score in Elderly Patients With Malnutrition: A Double Blind Randomized Controlled Trial

Indonesia University0 个研究点目标入组 90 人开始时间: 2016年10月5日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
90
主要终点
Serum IGF-1

研究概览

简要总结

This study is a double-blind randomized controlled trial comparing the effect of Ophiocephalus striatus extract in elderly patients with malnutrition. The measured outcomes are the level of IGF-1, albumin, and MNA score.

详细描述

This research was conducted in Cipto Mangunkusumo General Hospital and M. Djamil General Hospital, in collaboration with Biomedical Laboratory Faculty of Medicine University of Andalas and Prodia Laboratory, Indonesia. The inclusion criteria were elderly patients (≥ 60 y.o.) with malnutrition (MNA score ≤ 23,5) and hypoalbuminaemia (< 3,5 g/dL), had been treated, and permitted to leave from the hospital. All participants had been interviewed and physically examined to measure the anthropometric profile. Investigators also measured participant's Activity of Daily Living ADL Barthel, Geriatric Depression Scale (GDS), and Abbreviated Mental Test (AMT) to assess participant's compliance for consuming Ophiocephalus striatus extract. Blood samples were obtained to measure participant's level of IGF-1 and albumin before intervention.

Recruited-randomized participants were classified into two groups (control and intervention) with double-blind scheme. Intervention group was given the extract 5 grams two times/day for two weeks. After two weeks, all participants were invited back to out-patient clinic in hospital. MNA score was measured after the intervention. Blood sample were obtained again to know if there were any changes in IGF-1 level and albumin level.

Finally, investigators analyzed results to generate the conclusion.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elderly patient (≥ 60 y.o.)
  • Malnutrition or high risk for malnutrition (MNA score ≤ 23,5)
  • Hypoalbunemia (albumin level < 3,5 g/dL)

排除标准

  • chronic liver disease (liver cirrhosis) or severe liver dysfunction or increasing ALT > 3x normal
  • renal dysfunction with glomerulus filtration rate (< 30mL/minute)
  • nephrotic syndrome
  • acute infection / stroke / trauma
  • neoplasma
  • depression with Geriatric Depression Scale > 10
  • hypersensitivity to Ophiocephalus striatus
  • receive parenteral albumin
  • refuse to accept the treatment

结局指标

主要结局

Serum IGF-1

时间窗: 2 weeks

IGF-1 will be measured from blood serum. The level will be compared between intervention and control group (ng/mL)

MNA score

时间窗: 2 weeks

MNA score was measured from direct anamnesis to the patient (or family) and anthropometric profile.

Serum albumin

时间窗: 2 weeks

Albumin will be measured from blood serum. The level will be compared between intervention and control group (g/dL)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Roza Mulyana

MD

Indonesia University

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