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临床试验/NCT04078048
NCT04078048已完成不适用

Role of Selected Antioxidants (Vitamin C and E) in the Management of Schizophrenia

University of Health Sciences Lahore2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2017年4月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
2
主要终点
Positive and Negative Syndrome Scale

研究概览

简要总结

Background: Antioxidants are substances that are considered as a defensive material which protects cells from destruction. It is evident that use of food stuff rich in antioxidant will fortify one's ability to encounter with physical & mental disorders. Since, among several potential elucidations, oxidative stress is more likely deliberated as one of the causative factors which give rise to cognitive and functional impairment. This deterioration further result in intricacy in ones thought process as progressive brain changes crop-up schizophrenic unfold. Therefore, this study was conducted with objectives to explore the role of selected antioxidants (vitamin C & E) and to compare the role of both vitamins as an add-on management of schizophrenia .Materials & Methods: One hundred and five patients were selected from department of psychiatry King Edward Medical University Lahore, and assigned into 3 groups by simple random lottery method. For eight weeks, Vitamin C group intervened with 500mg vitamin C tablet once a day, vitamin E group with 600IU vitamin E twice daily and placebo group was given 500 mg paraffin oil capsule daily. PANSS scale was used to assess the symptoms of schizophrenia. Demographic information was collected by structured questionnaire. Dietary habits were assessed by food frequency questionnaire.

详细描述

Background: Antioxidants such as Vitamin C and E are substances that are considered as a defensive material which protects cells from destruction. It is evident that use of food stuff rich in antioxidant will fortify one's ability to encounter with physical & mental disorders. Since, among several potential elucidations, oxidation stress is more likely deliberated as one of the causative factors which give rise to cognitive and functional impairment. Therefore, this study was conducted with objectives to explore the role of selected antioxidants (vitamin C & E) and to compare the role of both vitamins as an add-on management of schizophrenia .Materials & Methods: One hundred and five patients were selected from department of psychiatry King Edward Medical University Lahore, and assigned into 3 groups by simple random lottery method. For the period of two months, Vitamin C group intervened with 500 mg vitamin C tablet once a day, vitamin E group with 600 I U vitamin E twice daily and placebo group was given 500 mg paraffin oil capsule daily. PANSS (Positive and Negative Symptoms Scale) was used to assess the symptoms of schizophrenia. Demographic information was collected by structured questionnaire. Dietary habits were assessed by (FFQ) food frequency questionnaire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • INCLUSION CRITERIA:
  • All diagnosed schizophrenic patients 20-50 years of age
  • visited department of psychiatry & behavioral sciences King Edward medical university Lahore.
  • EXCLUSION CRITERIA:
  • Patients diagnosed with axis i and axis ii disorders
  • having any other pathological condition like hypertension, hyperlipidemia, and cardiac disorders.

排除标准

  • 未提供

研究组 & 干预措施

Vitamin C Group

Experimental

Tablet Vitamin C 500 mg Once a day

干预措施: Antioxidants (Vitamin C, E ) (Dietary Supplement)

Vitamin E Group

Experimental

Tablet Vitamin E 600 I U Twice daily

干预措施: Antioxidants (Vitamin C, E ) (Dietary Supplement)

Placebo Group

Placebo Comparator

Capsule Paraffin oil 500 mg Once a day

干预措施: Antioxidants (Vitamin C, E ) (Dietary Supplement)

结局指标

主要结局

Positive and Negative Syndrome Scale

时间窗: 45-50 minutes

The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia.The PANSS yields a total average symptom score, based on 30 items rated from one to seven (range=30-210). Higher scores indicate more severe symptoms.

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

Saima Zahid

Principal Investigator

University of Health Sciences Lahore

研究点 (2)

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