Determining the effectiveness of nanocurcumin on the immune system of patients with HIV
Design
In this project, participants in two control groups who use only basic drugs for the treatment of HIV and intervention group who in addition to basic drugs use nanocrocumine according to the protocol. The number of participants in this project is 100 people who are divided into two groups of 50 people. They are divided into two groups accidentally.
Settings and conduct
In this project, 50 HIV-infected patients who refer to the Behavioral Diseases Counseling Center of Imam Khomeini Hospital will be examined for one year, and every 6 months blood CD4 count and viral loads will be tested. It is performed annually for them and patients are re-examined for safety and viral load after treatment with nanocurcumin.
Participants/Inclusion and exclusion criteria
Terms of participation in the project
• Having informed and voluntary consent in writing
• The patient has two reactive HIV ELISA tests.
People who have the following conditions at the beginning of the study will not be included in the study:
• The number of viruses in their blood is undetectable.
• The patient has hepatitis B or C.
• Pregnancy and lactation
• Current drug or alcohol use
• Growth hormone use (30 days before enrollment)
Use of testosterone or anabolic steroids (30 days before enrollment)
Long-term treatment with immunosuppressive drugs (except topical steroids)
Chemotherapy, interferon therapy or radiotherapy (three weeks before enrollment)
Intervention groups
Intervention group: A group that uses nanocurcumin in addition to basic drugs to treat HIV. This drug contains curcumin, which is active except turmeric root. The other two main curcuminoids (dimethoxy curcumin and bis dimethoxy curcumin) are also components of this drug. This medicine is a 40 mg tablet daily for 3 months.
Main outcome variables
Viral load and CD4 T cell count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210216050373N4
Registration date:2022-05-28, 1401/03/07
Registration timing:prospective
Last update:2022-05-28, 1401/03/07
Update count:0
Registration date
2022-05-28, 1401/03/07
Registrant information
Name
Seyed ahmad Seyed alinaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1583
Email address
s_a_alinaghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-06, 1401/04/15
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and efficiency of curcumin in the immune system and viral load of patient with HIV
Public title
The evaluation the effect of nanocurcommin in people living with HIV
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
people with positive test ( PCR)
people with positive test ( Elisa)
Exclusion criteria:
Patient with hepatitis B
Patient with hepatitis C
Pregnancy
Breastfeeding
Alcohol and Drug use
Use of Growth Hormone (at least 30 days before the study)
Use of Immunosuppressive drugs
Use of Testosterone and Anabolic Steroids (at least 30 days before the study)
Under Chemotherapy with Interferon or Radiotherapy
Patients with Undetectable viral loads
Age
From 18 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method will be used. Random number table is a set of numbers that are generated completely randomly and are tabulated. Firstly, we determine the direction of the random number table and then we decide to read the random number table from above. Then we consider even numbers for the intervention group and odd numbers for the control group.
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
Ethics committee of Imam khomeini Hospital Complex- Tehran University of Medical Sciences
Control group: A group that only takes routine HIV medications.
Category
Treatment - Drugs
2
Description
Intervention group: A group that uses nanocurcumin in addition to basic drugs to treat HIV. This drug contains curcumin, which is active except turmeric root. The other two main curcuminoids (dimethoxy curcumin and bis dimethoxy curcumin) are also components of this drug. This medicine is a 40 mg tablet daily for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
HIV research center Emam Khomeini hospital
Full name of responsible person
Abbas Bahrami
Street address
Blvd Keshavarz Emam hospital HIV research center
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1583
Email
bahramiab34@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Vice Chancellor of Research, Tehran University of Medical Sciences, Qods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
SeyedAhmad SeyedAlinaghi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Epidemiology
Street address
Tehran,keshavarz Blvd,Emam khomeini hospital,HIV research center
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1583
Email
s_a_alinaghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
SeyedAhmad SeyedAlinaghi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Epidemiology
Street address
Tehtan,Blvd keshavarz,Emam khomeini hospital,HIV research center
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1583
Email
s_a_alinaghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Abdoli
Position
researcher
Latest degree
Master
Other areas of specialty/work
Laboratory Medicine
Street address
Blvd keshavarz,Emam Khomeini hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1583
Email
sepidehabd7@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available