In this study effect of zinthoma in prevention of antiretroviral-induced nausea and vomiting will be evaluated. HIV positive patients who are candidate for antiretroviral therapy and without history of gastrointestinal diseases, allergy to zinthoma or using of other drugs that can induce nausea and vomiting will be recruited. In this clinical trial 80 HIV positive patients will be simply randomized to drug (zinthoma 500 mg, 30 minute before each dose of antiretroviral every 12 h) or placebo (500 mg, 30 minute before each dose of antiretroviral every 12 h) for 14 days. Occurrence of nausea and its severity and also number of vomiting episodes will be evaluated daily by investigator. Visual analogue scale will be used for evaluation of severity of patients' nausea. Effects of zinthoma in prevention of antiretroviral induced nausea and vomiting will be assessed by comparing of numbers and severity of nausea and vomiting episodes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305283449N12
Registration date:2013-06-17, 1392/03/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-17, 1392/03/27
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Grant of Tehran University of Medical Sciences
Expected recruitment start date
2011-02-01, 1389/11/12
Expected recruitment end date
2013-08-01, 1392/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of zinthoma efficacy in prevention of antiretrovirals nausea and vomiting in HIV positive patients
Public title
Zinthoma, Antiretroviral and Nausea and Vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: HIV positive patients who are candidate for Antiretroviral therapy and who signe study consent form.
Exclusion criteria: History of zinthoma or othera herbal products hypersensitivity
Age
From 16 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Ghods Ave, Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2010-08-26, 1389/06/04
Ethics committee reference number
89-03-33-11312
Health conditions studied
1
Description of health condition studied
HIV/AIDS
ICD-10 code
B20-B24
ICD-10 code description
Human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Frequency of Nausea and Vomoting
Timepoint
During 2 weeks of starting antiretroviral
Method of measurement
Visual analouge scale
Secondary outcomes
1
Description
Severity of nausea
Timepoint
Dring 2 weeks of starting antiretroviral
Method of measurement
Visual analogue scale
Intervention groups
1
Description
Intervention (Drug): Zinthoma 2 Cap (500 mg)30 minutes before each dose of antiretroviral twice daily for 14 days
Category
Treatment - Drugs
2
Description
Control: Placebo 2 Cap ( 500 mg) 30 minutes before each dose of antiretroviral twice daily for 14 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hossein Khalili
Street address
keshavarz BLV.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Saeedi
Street address
Tehran University of Medical Sciences, Ghods Ave, keshavarz Blv, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm D
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Enghelab Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6695 4709
Fax
Email
khalilih@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein khalili
Position
Pharm D
Other areas of specialty/work
Street address
Tehran University of Medical Sciencesو Enghelab Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6695 4715
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)