Clinical trial NCT02216045: Effect of Camel Milk on Chronic Hepatitis C
Official title: Investigating the Effects of Camel Milk Products on the Laboratory Markers in the Patients With Chronic Hepatitis C, Genotype 2 & 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: Hepatitis C ,Chronic Hepatitis C ,camel milk
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 )

Primary outcomes:
measure: Early Virologic Responses(EVR)
timeFrame: After 4 weeks of Treatment
measure: Early Virologic Responses(EVR)
timeFrame: 4 weeks after of treatment
Secondary outcomes:
measure: Complete early virological response (cEVR)
timeFrame: 12 weeks after initiation of treatment
measure: o Complete early virological response (cEVR)
timeFrame: 12 weeks after initiation of treatment
measure: o Sustained virological response (SVR)
timeFrame: 12 weeks after initiation of treatment
measure: o Sustained virological response (SVR)
timeFrame: 12 weeks after initiation of treatment
measure: o Normalization of ALT( Alanine Aminotransferase)
timeFrame: during the treatment and 12 weeks of treatment
measure: o Normalization of ALT
timeFrame: during the treatment and 12 weeks of treatment
measure: o Adverse events(AE)
timeFrame: Up to 12 weeks
measure: o Adverse events(AE)
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Faculty of Traditional Medicine
state: Khorasan-e-Razavi
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University of Medical Sciences
state: Khorasan-e-Razavi
Study officials:
affiliation: Ghaem Gastrointestinal Clinic
name: Seyyd Musa Al-Reza Hosseini, professor.As
role: STUDY_CHAIR
affiliation: Faculty of Traditional Medicine Clinic
name: Mehdi Yousefi, MD.Phd
role: STUDY_DIRECTOR
affiliation: Faculty of Traditional Medicine Clinic
name: Mohammadreza Noras, Phd student
role: PRINCIPAL_INVESTIGATOR
affiliation: MUMS Faculty of Health Sciences
name: Ali Taghipour, MD.Phd
role: STUDY_DIRECTOR
affiliation: Razi vaccine and serum Research Institue of Mashhd
name: Said Zibae, MD.Phd
role: STUDY_DIRECTOR
References: