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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peginterferon ,Ribavirin | Active Comparator | drug :Peginterferon, Ribavirin, |
|
| Peginterferon, Ribavirin, camel milk | Experimental | drug :Peginterferon, Ribavirin, camel milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| o Complete early virological response (cEVR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seyyd Musa Al-Reza Hosseini, professor.As | Ghaem Gastrointestinal Clinic | Study Chair |
| Mehdi Yousefi, MD.Phd | Faculty of Traditional Medicine Clinic | Study Director |
| Mohammadreza Noras, Phd student | Faculty of Traditional Medicine Clinic | Principal Investigator |
| Ali Taghipour, MD.Phd | MUMS Faculty of Health Sciences | Study Director |
| Said Zibae, MD.Phd | Razi vaccine and serum Research Institue of Mashhd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Traditional Medicine | Mashhad | Razavi Khorasan Province | Iran | |||
| Mashhad University of Medical Sciences |
individual participant data (IPD) is confidential in researchers .
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
|
| 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. |
|
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| o Adverse events(AE) | Number of participants experiencing adverse events | Up to 12 weeks |
| o Adverse events(AE) | Number of participants discontinuing study treatment because of adverse events | Up to 12 weeks |
| Mashhad |
| Razavi Khorasan Province |
| Iran |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |