Investigating the Effects of Camel Milk Products on the Laboratory Markers in the Patients With Chronic Hepatitis C, Genotype 2 & 3
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Early Virologic Responses(EVR)
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCV (hepatitis C virus ) RNA positive
- •Age age groups (18 to 70 years)
排除标准
- •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 )
研究组 & 干预措施
Peginterferon ,Ribavirin
drug :Peginterferon, Ribavirin,
干预措施: Peginterferon, Ribavirin (Drug)
Peginterferon, Ribavirin, camel milk
drug :Peginterferon, Ribavirin, camel milk
干预措施: Peginterferon, Ribavirin, camel milk (Drug)
结局指标
主要结局
Early Virologic Responses(EVR)
时间窗: 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
次要结局
- Complete early virological response (cEVR)(12 weeks after initiation of treatment)
- o Complete early virological response (cEVR)(12 weeks after initiation of treatment)
- o Sustained virological response (SVR)(12 weeks after initiation of treatment)
- o Normalization of ALT( Alanine Aminotransferase)(during the treatment and 12 weeks of treatment)
- o Normalization of ALT(during the treatment and 12 weeks of treatment)
- o Adverse events(AE)(Up to 12 weeks)
研究者
mohammadreza noras
Phd student
Mashhad University of Medical Sciences