Effect of Camel Milk on Chronic Hepatitis C

Chronic Hepatitis C Clinical Trial

— HCV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216045
• Other study ID #: Mashhad UMS
• Status: Completed
• Phase: Phase 2
• First received: July 26, 2014
• Last updated: July 28, 2016
• Start date: June 2014
• Est. completion date: February 2015

Study information

• Verified date: July 2016
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peginterferon, Ribavirin, camel milk
Peginterferon One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNa-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.
• Peginterferon, Ribavirin
Peginterferon (PegIFNa-2a) One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNa-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.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	o Adverse events(AE)	Number of participants experiencing adverse events	Up to 12 weeks	Yes
Secondary	o Adverse events(AE)	Number of participants discontinuing study treatment because of adverse events	Up to 12 weeks	Yes