Effect of Camel Milk on Chronic Hepatitis C (HCV)

Mashhad University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: Peginterferon, Ribavirin; Drug: Peginterferon, Ribavirin, camel milk

Study type: Interventional

Funder types: Other

Identifiers

NCT02216045

Mashhad UMS

Details and patient eligibility

About

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 .

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 )

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Peginterferon ,Ribavirin

Active Comparator group

Description:

drug :Peginterferon, Ribavirin,

Treatment:

Drug: Peginterferon, Ribavirin

Peginterferon, Ribavirin, camel milk

Experimental group

Description:

drug :Peginterferon, Ribavirin, camel milk

Treatment:

Drug: Peginterferon, Ribavirin, camel milk