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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12610000958088 |
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Date of registration:
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09/11/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Spirulina Platensis in the Treatment of Chronic Hepatitis C Virus (HCV) Infection
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Scientific title:
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Chronic hepatitis C patients - treated with either Spirulina platensis or Silymarin capsules - study for virological response, alanine aminotransferase enzyme, chronic liver disease questionnaire score for health related quality of life and Arizona sexual experience scale for sexual functions. |
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Date of first enrolment:
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20/10/2008 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12610000958088.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;
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Phase:
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Not Applicable
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Mostafa Yakoot
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Address:
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27 Green Street, Alexandria 21121
Egypt |
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Telephone:
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+20123927561 |
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Email:
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yakoot@yahoo.com |
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Affiliation:
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Name:
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Mostafa Yakoot
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Address:
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27 Green Street, Alexandria 21121
Egypt |
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Telephone:
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+20123927561 |
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Email:
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yakoot@yahoo.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Chronic HCV genotype 4 diagnosis
HCV RNA positive with or without elevated liver enzymes
Exclusion criteria: Pregnancy
Active schistosomiasis
HIV
HBV
Critically ill
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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chronic hepatitis C;
chronic hepatitis C
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Infection - Other infectious diseases
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Intervention(s)
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Spirulina oral capsules of 500 mg dry powder extract in a dose of one capsule three times daily for 6 months.
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Primary Outcome(s)
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Early virological response (EVR) either: complete (c-EVR) defined as loss of detectable hepatitis C virus RNA by quantitative PCR laboratory test; at the end of 3 months treatment;
or partial (p-EVR) defined as reduction of the virus load by at least 2 Logs10 at the end of 3 months treatment[3 months]
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End of treatment virological response (ETR) either: complete (c-ETR) defined as loss of detectable hepatitis C virus RNA by quantitative PCR laboratory test at the end of 6 months treatment;
or partial (p-ETR) defined as reduction of the virus load by at least 2 Logs10 at the end of 6 months treatment[6 months]
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Secondary Outcome(s)
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Sexual functions by the Arizona Sexual Experience Scale (ASEX) scores[6 months]
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Health related quality of life by Chronic Liver Disease Questionnaire (CLDQ) score[6 months]
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Normalization of Alanine aminotransferase by laboratory analysis of the enzyme level in the serum from blood samples.[6 months]
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Source(s) of Monetary Support
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Beovita pharma (A Joint German-Egyptian Company
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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