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Trial record 10 of 1862 for:    "Hepatitis, Chronic"

Effect of Camel Milk on Chronic Hepatitis C (HCV)

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ClinicalTrials.gov Identifier: NCT02216045
Recruitment Status : Completed
First Posted : August 13, 2014
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
mohammadreza noras, 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 .

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Peginterferon, Ribavirin, camel milk Drug: Peginterferon, Ribavirin Phase 2

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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating the Effects of Camel Milk Products on the Laboratory Markers in the Patients With Chronic Hepatitis C, Genotype 2 & 3
Study Start Date : June 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

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 Name: 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 Name: PEGASYS® COPEGUS®. Dromedary milk (camel milk )




Primary Outcome Measures :
  1. Early Virologic Responses(EVR) [ Time Frame: After 4 weeks 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 ( interferon) + RBV.

  2. Early Virologic Responses(EVR) [ Time Frame: 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 :
  1. Complete early virological response (cEVR) [ Time Frame: 12 weeks after initiation of treatment ]
    defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV

  2. o Complete early virological response (cEVR) [ Time Frame: 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

  3. o Sustained virological response (SVR) [ Time Frame: 12 weeks after initiation of treatment ]
    defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment by PEG IFN +RBV

  4. o Sustained virological response (SVR) [ Time Frame: 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

  5. o Normalization of ALT( Alanine Aminotransferase) [ Time Frame: 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.

  6. o Normalization of ALT [ Time Frame: 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.

  7. o Adverse events(AE) [ Time Frame: Up to 12 weeks ]
    Number of participants experiencing adverse events

  8. o Adverse events(AE) [ Time Frame: Up to 12 weeks ]
    Number of participants discontinuing study treatment because of adverse events



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02216045


Locations
Iran, Islamic Republic of
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
Sponsors and Collaborators
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

Responsible Party: mohammadreza noras, Phd student, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02216045     History of Changes
Other Study ID Numbers: Mashhad UMS
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: July 29, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual participant data (IPD) is confidential in researchers .

Keywords provided by mohammadreza noras, Mashhad University of Medical Sciences:
Hepatitis C ,Chronic Hepatitis C ,camel milk

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents