The acquired immunodeficiency syndrome (AIDS) is a result of human immunodeficiency virus (HIV) infection which subsequently leads to significant suppression of immune functions. AIDS is a significant threat to the health of mankind, and the search for effective therapies to treat AIDS is of paramount importance. Several chemical anti-HIV agents have been developed. However, besides the high cost, there are adverse effects and limitations associated with using chemotherapy for the treatment of HIV infection Thus, herbal medicines have frequently been used as an alternative medical therapy by HIV positive individuals and AIDS patients. The purpose of the study: Determination of the anti-human immunodeficiency virus effect of Herbal Medicine, Feutel, on HIV infected Individuals. This study will be carried out without placebo control AND Zero trial stage and eight patient population study. The main criteria for selection of patients: patients who were not taken any medications before and during the study. Patients will take the drug twice a day with an interval of 12 hours. Exclusion criteria: those who doesn’t follow the strategy or plan.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071929000N1
Registration date:2016-07-30, 1395/05/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-30, 1395/05/09
Registrant information
Name
Tayebeh Hashempour
Name of organization / entity
The Pharmacy and Pharmaceutical Sciences Research Centre
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 2247
Email address
thashem@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology University of Medical Sciences
Expected recruitment start date
2016-08-02, 1395/05/12
Expected recruitment end date
2017-03-06, 1395/12/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the anti human immunodeficiency virus effect of Herbal Medicine, FEUTEL, on HIV infected Individuals
Public title
FEUTEL herbal combination to reduce HIV replication
Purpose
Treatment
Inclusion/Exclusion criteria
The main criteria for selection of patients: patients who were not taken any medications before and during the study. Patients will take the drug twice a day with an interval of 12 hours. Exclusion criteria: those who doesn’t follow the strategy or plan.
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
8
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Deputy and Technology Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
SHIRAZ
Postal code
Approval date
2016-07-17, 1395/04/27
Ethics committee reference number
IR.SUMS.REC.1395.39
Health conditions studied
1
Description of health condition studied
HIV
ICD-10 code
Z21
ICD-10 code description
Asymptomatic human immunodeficiency virus [HIV] infection status
Primary outcomes
1
Description
The evaluation of CD4
Timepoint
Twenty days before the intervention and after the intervention.
Method of measurement
Flow cytometry
Secondary outcomes
1
Description
The viral load
Timepoint
Twenty days before the intervention and after the intervention.
Method of measurement
Real-Time PCR
Intervention groups
1
Description
Feutel Herbal Medicine -10 mg/kg-Twice a day- 12 hrs intervals
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Behavioral Diseases counseling center Shiraz
Full name of responsible person
Ahmad Hosseinpour
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology University of Medical Sciences
Full name of responsible person
Tayebeh Hashempour
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran Postal Code: 71345-1978 Tel: +98 71 32357282 Fax: +98 71 32307594
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology 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
Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Hosseinpour
Position
Community medicine specialist, National HIV/AIDS/STI Program Manager Center for Communicable Disease
Other areas of specialty/work
Street address
Shiraz HIV/AIDS Research Center,Building No. 2,First floor,Shiraz University of Medical Sciences,Moshir Fatemi Ave,Shiraz,Iran Tel/Fax:+98 711 2331933
City
Shiraz
Postal code
Phone
+98 71 3233 3282
Fax
Email
p.afsar50@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
The Pharmacy and Pharmaceutical Sciences Research Centre
Full name of responsible person
Tayebeh Hashempour
Position
PhD in medical Virology, Post Doc. fellow in virology
Other areas of specialty/work
Street address
Pharmaceutical Biotechnology Department; School of Pharmacy; Shiraz University of Medical Sciences, P. O. Box 1583; 71345 Shiraz; Iran
City
Shiraz
Postal code
Phone
+98 71 3647 4296
Fax
Email
thashem@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The Pharmacy and Pharmaceutical Sciences Research Centre
Full name of responsible person
Tayebeh Hashempour
Position
Faculty -PhD in medical Virology, Post Doc. fellow in virology
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)