The aim of this study is to determine the effect of honey intake on heamatological and biochemical variables in HIV positive patients. In this interventional study 30 HIV possitive patients will be allocated into 2 groups randomely, intervention and control. Patients who are before AIDS disease stage and don't use any antiviral drugs will be included the study. Other infectious disease during the study will be excluded. Intervention group will receive 1.2 gr/kg natural honey for 30 days. The heamatological and biochemical variables will be measured in two groups before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105246580N1
Registration date:2011-09-01, 1390/06/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-09-01, 1390/06/10
Registrant information
Name
Sepideh Mirzaie
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 1772 2243
Email address
heidari@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Qom University of Medical Sciences
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of natural honey on the blood index and biochemical markers of HIV positive persons
Public title
The effect of natural honey on the immune system of HIV positive persons
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: HIV positive case. Exclusion criteria: paitient with AIDS; useing antiviral drugs; patient with other infectious diseases during the study.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Qom University of Medical Sciences
Street address
lavasani st.
City
Qom
Postal code
37185
Approval date
2011-03-19, 1389/12/28
Ethics committee reference number
28095/34/پ
Health conditions studied
1
Description of health condition studied
HIV
ICD-10 code
R75
ICD-10 code description
laberatory evidences of HIV
Primary outcomes
1
Description
wbc
Timepoint
first day and 31th day
Method of measurement
CBC
2
Description
CD4
Timepoint
first day and 31th day
Method of measurement
blood sampling
3
Description
CD8
Timepoint
first day and 31th day
Method of measurement
blood sampling
4
Description
hemoglobin
Timepoint
first day and 31th day
Method of measurement
CBC
5
Description
platelet
Timepoint
first day and 31th day
Method of measurement
CBC
6
Description
serum protein
Timepoint
first day and 31th day
Method of measurement
blood sampling
7
Description
serum albumin
Timepoint
first day and 31th day
Method of measurement
blood sampling
8
Description
copper level
Timepoint
first day and 31th day
Method of measurement
blood sampling
Secondary outcomes
1
Description
adverse reactions
Timepoint
during the study
Method of measurement
History taking and examination
Intervention groups
1
Description
case group: 1.2 gr/kg/day natural honey for 30 days.
Category
Treatment - Other
2
Description
control group: this group does not take honey or placebo.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health center of Qom province
Full name of responsible person
Sepideh Mirzaie
Street address
Shahid Beheshti dormitory, Shahid Beheshti st.
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Alireza Koohpaei
Street address
Shahid Lavasani st.
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom 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
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Sepideh Mirzaie
Position
student
Other areas of specialty/work
Street address
Shahid Beheshti dormitory, Shahid Beheshti st.
City
Qom
Postal code
3719965755
Phone
+98 25 1661 0690
Fax
+98 25 1661 0690
Email
Mirzaie_se@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Sepideh Mirzaie
Position
general practitioner
Other areas of specialty/work
Street address
Shahid beheshti dormitory, Shahid Beheshti St.
City
Qom
Postal code
3719965755
Phone
+98 25 1661 0690
Fax
+98 25 1661 0690
Email
Mirzaie-se@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Sepideh Mirzaie
Position
student
Other areas of specialty/work
Street address
ShAhid Beheshti dormitory, Sahid Beheshti st.
City
Qom
Postal code
3719965755
Phone
+98 25 1661 0690
Fax
+98 25 1661 0690
Email
Mirzaie_se@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)