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Completed

NCT Number: NCT02216045

Effect of Camel Milk on Chronic Hepatitis C

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 .

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Traditional Medicine, Mashhad, Razavi Khorasan Province, Iran

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Peginterferon, Ribavirin, camel milk

Drug

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 )

Peginterferon, Ribavirin

Drug

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)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mashhad University of Medical Sciences

Other

Registry information

Official study title

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

Acronym: HCV

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2014
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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