Study: investigating the effects of Camel Milk Products on the laboratory markers in the patients with chronic hepatitis, genotype 2 & 3
Design of study: RCT
Study population: patients referred to a specialized clinic University
Main inclusion criteria: age 18 to 70 years; the detection of serum HCV RNA by PCR
Main exclusion criteria: decompensated cirrhosis; autoimmune diseases; cancer; lack of milk consumption with the dose; the patient withdrew from further participation in the plan;other genotypes
Sample size: 40 patients
Intervention group: Pegah interferon (Pgasys) at a dose of 180 mcg subcutaneously once weekly, and ribavirin dose of 800 to 1200 mg based on body weight orally daily and camel milk 250 cc daily in the morning and night for three months.
Control group: Pegah interferon (Pgasys) at a dose of 180 mcg subcutaneously once weekly, and ribavirin dose of 800 to 1200 mg based on body weight orally for three months.
C - Intervention Time: 3 months
D - Primary outcome or consequences of the study: laboratory changes ALT, AST, and PCR
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013112515533N1
Registration date:2014-08-20, 1393/05/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-20, 1393/05/29
Registrant information
Name
Mohammadreza Noras
Name of organization / entity
Faculty of Traditional Medicine
Country
Iran (Islamic Republic of)
Phone
+98 51 3855 2189
Email address
norasmr901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Razi vaccine and Serum Research Institue of Mashhad
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigating the effects of Camel Milk Products on the laboratory markers in the patients with chronic hepatitis, genotype 2 & 3
Public title
Effect of camel milk on chronic hepatitis C
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age 18 to 70 years؛ the detection of serum HCV RNA by PCR.
exclusion criteria:Decompensated cirrhosis; autoimmune diseases; cancer; infected with HIVorHBV;neutropenia;thrombocytopenia; creatinine higher;organ transplant;severe heart disease; chronic lung disease; uncontrolled psychiatric illness; epilepsy; diabetic retinopathy; active alcohol or addiction; pregnancy;anemia;non-compliance with the prescribed dosage milk; discourage patients from continuing to participate in the plan; other genotypesto participate in the plan; other genotypes
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Danehgah Street,Vice chancellor for research, University of Medical Sciences, Mashhad
City
Mashhad
Postal code
Approval date
2014-07-16, 1393/04/25
Ethics committee reference number
research/922662/1/1063
Health conditions studied
1
Description of health condition studied
Chronic hepatitis C
ICD-10 code
B18.2
ICD-10 code description
Chronic viral hepatitis C
Primary outcomes
1
Description
Quantification of HCV RNA
Timepoint
One Month
Method of measurement
PCR
2
Description
level of ALT,AST
Timepoint
One Month
Method of measurement
unit /ml
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pegah interferon (Pgasys) at a dose of 180 mcg subcutaneously once weekly, and ribavirin dose of 800 to 1200 mg based on body weight orally daily and camel milk 250 cc daily in the morning and night for three months.
Category
Treatment - Drugs
2
Description
Control group: Pegah interferon (Pgasys) at a dose of 180 mcg subcutaneously once weekly, and ribavirin dose of 800 to 1200 mg based on body weight orally for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Gastrointestinal Clinic
Full name of responsible person
Seyyd Musa Al-Reza Hosseini
Street address
Ahmadabad Street ,Ghaem Hospital,Ghaem Gastrointestinal Clinic,Mashhad
City
Mashhad
2
Recruitment center
Name of recruitment center
Faculty of Traditional Medicine Clinic
Full name of responsible person
Mohammadreza Noras
Street address
Faculty of Traditional Medicine
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences ,Vice chancellor for research
Full name of responsible person
Said Islame
Street address
Ghoreish Building, Daneshgah Street, University of Medical Sciences, Vice chancellor for research, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences ,Vice chancellor for research
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Razi vaccine and Serum research Institue of Mashhd
Full name of responsible person
Said Zibae
Street address
Razi vaccine and Serum research Institue of Mashhd
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi vaccine and Serum research Institue of Mashhd
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Traditional Medicine
Full name of responsible person
Mohammadreza Noras
Position
Phd student Traditional Medicine
Other areas of specialty/work
Street address
Faculty of Traditional Medicine
City
Mashhd
Postal code
Phone
+98 51 3855 2189
Fax
Email
norasmr901@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Medicine Internal Clinic, Ghaem Hospital
Full name of responsible person
Seyyd Musa Al-Reza Hosseini
Position
Subspecialist of Gastroenterology
Other areas of specialty/work
Street address
Ahmadabad Street, Department of Medicine Internal, Ghaem Hospital, Mashhad
City
Mashhd
Postal code
Phone
+98 51 3801 2742
Fax
Email
HoseiniMR@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Traditional Medicine
Full name of responsible person
Mohammadreza Noras
Position
Phd student Traditional Medicine
Other areas of specialty/work
Street address
City
Mashhd
Postal code
Phone
+98 51 3855 2189
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)