Effect of Camel Milk on Chronic Hepatitis C

Phase 2

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Peginterferon, Ribavirin; Drug: Peginterferon, Ribavirin, camel milk

• Registration Number: NCT02216045
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

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 .

Detailed 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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-26
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-13
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 )

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peginterferon ,Ribavirin	Peginterferon, Ribavirin	drug :Peginterferon, Ribavirin,
Peginterferon, Ribavirin, camel milk	Peginterferon, Ribavirin, camel milk	drug :Peginterferon, Ribavirin, camel milk

Primary Outcome Measures

Name	Time	Method
Early Virologic Responses(EVR)	4 weeks after of treatment	Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment by PEG IFN + RBV+camel milk

Secondary Outcome Measures

Name	Time	Method
Complete early virological response (cEVR)	12 weeks after initiation of treatment	defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV
o Complete early virological response (cEVR)	12 weeks after initiation of treatment	defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV+camel milk
o Sustained virological response (SVR)	12 weeks after initiation of treatment	defined by HCV RNA below the detection limit based on quantitative PCR(polymerase chain reaction ) 12 weeks after stopping treatment by PEG IFN +RBV+camel milk
o Normalization of ALT( Alanine Aminotransferase)	during the treatment and 12 weeks of treatment	Proportion of patients who have ALT below the upper limit of normal (ULN) during the treatment by PEG IFN +RBV and 12 weeks after the end of treatment.
o Normalization of ALT	during the treatment and 12 weeks of treatment	Proportion of patients who have ALT below the upper limit of normal (ULN) during the treatment by PEG IFN +RBV+camel milk and 12 weeks after of treatment.
o Adverse events(AE)	Up to 12 weeks	Number of participants discontinuing study treatment because of adverse events

Trial Locations

Locations (2)

Faculty of Traditional Medicine; 🇮🇷 Mashhad, Khorasan-e-Razavi, Iran, Islamic Republic of

Mashhad University of Medical Sciences; 🇮🇷 Mashhad, Khorasan-e-Razavi, Iran, Islamic Republic of