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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Antioxidants (Vitamin C, E )
Sponsored by
University of Health Sciences Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Positive and Negative syndrome scale (PANSS), Antioxidants, Schizophrenia

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-

Sites / Locations

  • Saima Kouser

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Vitamin C Group

Vitamin E Group

Placebo Group

Arm Description

Tablet Vitamin C 500 mg Once a day

Tablet Vitamin E 600 I U Twice daily

Capsule Paraffin oil 500 mg Once a day

Outcomes

Primary Outcome Measures

Positive and Negative Syndrome Scale
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.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2019
Last Updated
September 13, 2019
Sponsor
University of Health Sciences Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT04078048
Brief Title
Role of Antioxidants (Vitamin C and E) in the Management of Schizophrenia
Official Title
Role of Selected Antioxidants (Vitamin C and E) in the Management of Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 27, 2017 (Actual)
Primary Completion Date
August 11, 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Health Sciences Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Positive and Negative syndrome scale (PANSS), Antioxidants, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin C Group
Arm Type
Experimental
Arm Description
Tablet Vitamin C 500 mg Once a day
Arm Title
Vitamin E Group
Arm Type
Experimental
Arm Description
Tablet Vitamin E 600 I U Twice daily
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Capsule Paraffin oil 500 mg Once a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Antioxidants (Vitamin C, E )
Other Intervention Name(s)
Tablet Vitamin E
Intervention Description
For eight weeks, Vitamin C group was intervened with tablet vitamin c 500 mg once a day ,vitamin E group was intervened with Tablet vitamin E 600 I U twice a day.
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale
Description
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.
Time Frame
45-50 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: -
Facility Information:
Facility Name
Saima Kouser
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
clinical trails registration

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

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