Trial | NCT02216045  Report issue

Title

Effect of Camel Milk on Chronic Hepatitis C
Investigating the Effects of Camel Milk Products on the Laboratory Markers in the Patients With Chronic Hepatitis C, Genotype 2 & 3

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
Camel milk as the new modality for treatment of chronic hepatitis C. The purpose of this study is to evaluate effectiveness and safety of camel milk in combination with Peginterferon Alfa-2a and Ribavirin in genotype 2,3 chronic hepatitis C virus .
The investigators enrolled 40 patients into the study. Group 1(Intervention ) : received PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily and 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.

Group 2 ( control ): received PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for 12 weeks.

Follow up period is 1,2,3 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the first months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the third month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.
Study Started
Jun 30
2014
Primary Completion
Feb 28
2015
Study Completion
Feb 28
2015
Last Update
Jul 29
2016
Estimate

Drug Peginterferon, Ribavirin, camel milk

Peginterferon One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks. Ribavirin (RBV) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks . camel milk 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.

  • Other names: PEGASYS® COPEGUS®. Dromedary milk (camel milk )

Drug Peginterferon, Ribavirin

Peginterferon (PegIFNα-2a) One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks. Ribavirin (RBV) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks.

  • Other names: PEGASYS® (Peginterferon ) , COPEGUS® (Ribavirin)

Peginterferon ,Ribavirin Active Comparator

drug :Peginterferon, Ribavirin,

Peginterferon, Ribavirin, camel milk Experimental

drug :Peginterferon, Ribavirin, camel milk

Criteria 

Inclusion Criteria:

HCV (hepatitis C virus ) RNA positive
Age age groups (18 to 70 years)

Exclusion Criteria:

Ongoing pregnancy or breast feeding
Hx of HCC(hepatocellular carcinoma )
Hx of alcoholic liver disease
Hx of bleeding from esophageal varices
Hx of hemochromatosis
Hx of autoimmune hepatitis
Hx of Suicidal attempt
Hx of cerebrovascular dis
Hx of severe retinopathy
Hx of severe psoriasis
Hx of scleroderma
Hx of metabolic liver disease
Hx of SLE(systemic lupus erythematosus )
No Results Posted