Effect of Camel Milk on Chronic Hepatitis C (HCV)

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

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 .

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C
• Intervention / Treatment: Drug: Peginterferon, Ribavirin; Drug: Peginterferon, Ribavirin, camel milk

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Khorasan-e-Razavi
    • Mashhad, Khorasan-e-Razavi, Iran, Islamic Republic of
      • Faculty of Traditional Medicine
    • Mashhad, Khorasan-e-Razavi, Iran, Islamic Republic of
      • Mashhad University Of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Peginterferon ,Ribavirin; drug :Peginterferon, Ribavirin,	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)
Experimental: Peginterferon, Ribavirin, camel milk; drug :Peginterferon, Ribavirin, camel milk	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 )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Virologic Responses(EVR)	Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment by PEG IFN ( interferon) + RBV.	After 4 weeks of Treatment
Early Virologic Responses(EVR)	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	4 weeks after of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete early virological response (cEVR)	defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV	12 weeks after initiation of treatment
o Complete early virological response (cEVR)	defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV+camel milk	12 weeks after initiation of treatment
o Sustained virological response (SVR)	defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment by PEG IFN +RBV	12 weeks after initiation of treatment
o Sustained virological response (SVR)	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	12 weeks after initiation of treatment
o Normalization of ALT( Alanine Aminotransferase)	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.	during the treatment and 12 weeks of treatment
o Normalization of ALT	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.	during the treatment and 12 weeks of treatment
o Adverse events(AE)	Number of participants experiencing adverse events	Up to 12 weeks
o Adverse events(AE)	Number of participants discontinuing study treatment because of adverse events	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Mashhad University of Medical Sciences
• Investigators: Study Chair: Seyyd Musa Al-Reza Hosseini, professor.As, Ghaem Gastrointestinal Clinic; Study Director: Mehdi Yousefi, MD.Phd, Faculty of Traditional Medicine Clinic; Principal Investigator: Mohammadreza Noras, Phd student, Faculty of Traditional Medicine Clinic; Study Director: Ali Taghipour, MD.Phd, MUMS Faculty of Health Sciences; Study Director: Said Zibae, MD.Phd, Razi vaccine and serum Research Institue of Mashhd

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: July 26, 2014
• First Submitted That Met QC Criteria: August 12, 2014
• First Posted (Estimate): August 13, 2014

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Hepatitis C ,Chronic Hepatitis C ,camel milk
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Hepatitis, Chronic; Hepatitis C, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Immunologic Factors; Interferon-alpha; Ribavirin; Peginterferon alfa-2a
• Other Study ID Numbers: Mashhad UMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: individual participant data (IPD) is confidential in researchers .