Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000958088
Ethics application status
Approved
Date submitted
3/11/2010
Date registered
9/11/2010
Date last updated
9/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Spirulina Platensis in the Treatment of Chronic Hepatitis C Virus (HCV) Infection
Scientific title
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.
Secondary ID [1] 253013 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic hepatitis C 258563 0
Condition category
Condition code
Infection 258704 258704 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Spirulina oral capsules of 500 mg dry powder extract in a dose of one capsule three times daily for 6 months.
Intervention code [1] 257535 0
Treatment: Drugs
Comparator / control treatment
Silymarin oral capsules of 140 mg in a dose of one capsule three times daily for 6 months.
Control group
Active

Outcomes
Primary outcome [1] 259566 0
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
Timepoint [1] 259566 0
6 months
Primary outcome [2] 259567 0
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
Timepoint [2] 259567 0
3 months
Secondary outcome [1] 266186 0
Normalization of Alanine aminotransferase by laboratory analysis of the enzyme level in the serum from blood samples.
Timepoint [1] 266186 0
6 months
Secondary outcome [2] 266187 0
Health related quality of life by Chronic Liver Disease Questionnaire (CLDQ) score
Timepoint [2] 266187 0
6 months
Secondary outcome [3] 266188 0
Sexual functions by the Arizona Sexual Experience Scale (ASEX) scores
Timepoint [3] 266188 0
6 months

Eligibility
Key inclusion criteria
Chronic HCV genotype 4 diagnosis
HCV RNA positive with or without elevated liver enzymes
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Active schistosomiasis
HIV
HBV
Critically ill

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment was assured by keeping the randomization list and the drug codes locked in sealed opaque envelopes till the end of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
consecutive patients presenting to the OPD with eligibility criteria had been asked to sign informed consent and randomized through software generated block randomization to either one of two similar capsules in similar packs
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3015 0
Egypt
State/province [1] 3015 0
Alexandria

Funding & Sponsors
Funding source category [1] 257985 0
Commercial sector/Industry
Name [1] 257985 0
Beovita pharma (A Joint German-Egyptian Company
Country [1] 257985 0
Germany
Primary sponsor type
Charities/Societies/Foundations
Name
Abbass Helmy Charity
Address
Alexandria, 61 Ismail Serry Street.
Country
Egypt
Secondary sponsor category [1] 257185 0
None
Name [1] 257185 0
Address [1] 257185 0
Country [1] 257185 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31864 0
Address 31864 0
Country 31864 0
Phone 31864 0
Fax 31864 0
Email 31864 0
Contact person for public queries
Name 15111 0
Mostafa Yakoot
Address 15111 0
27 Green Street, Alexandria 21121
Country 15111 0
Egypt
Phone 15111 0
+20123927561
Fax 15111 0
Email 15111 0
yakoot@yahoo.com
Contact person for scientific queries
Name 6039 0
Mostafa Yakoot
Address 6039 0
27 Green Street, Alexandria 21121
Country 6039 0
Egypt
Phone 6039 0
+20123927561
Fax 6039 0
Email 6039 0
yakoot@yahoo.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.