Protocol summary

Summary
Aim of the study: Evaluation of efficacy and safety of Valerian for prevention of neuropsychiatric adverse effects of Efavirenz in HIV positive patients. Design: A Randomized Placebo Controlled Clinical Trial Patients: 50 patients with confirmed HIV infection, aged 18-65 years old who are candidate for antiretroviral therapy with Efavirenz will be included. Pregnant and lactating women, patients with positive history of neuropyschiatric disorders and who are receiving mood affecting agents will be excluded. Included patients will be assigned to drug or placebo group based on the block randomization method. Patients in the drug group will be receive 2 capsules of Sedamin ( 530 mg of dry extract of Valerian root- GolDaru Pharmaceutical Company- Isfahan-IRAN), 2 hours before bed time for 4 weeks. Patients in the placebo group will be receive 2 capsules of Placebo (GolDaru Pharmaceutical Company- Isfahan-IRAN), 2 hours before bed time for 4 weeks. Assessment: Patients will be followed up in term of the neuropsychiatric adverse effects of Efavirenz (depression, anxiety, sleep disturbance, positive and negative suicide ideation, psychotic symptoms) based on the Hamilton Anxiety and Depression, Pittsburgh Sleep Quality, Positive and Negative Suicide Ideation and Negative and Positive Symptoms of Psychosis questionnaires at times 0 and week 4. Also adverse effects of the Valerian will be evaluated in the patients during the study period. At end of the study efficacy and safety of Valerian in prevention of neuropsychiatrics adverse effects of Efavirenz will be compared with placebo.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201504053449N18
Registration date: 2015-12-06, 1394/09/15
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-06, 1394/09/15
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
Tehran University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2017-04-19, 1396/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing efficacy and safety of Valerian and Placebo for prevention of Efavirenz-induced anxiety and depression in HIV positive patients
Public title
Valerian for prevention of neuropsychiatric adverse effects of Efavirenz in HIV positive patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with confirmed HIV infection, between 18-65 years old, receiving Efavirenz containing antiretroviral treatment. Exclusion criteria: Pregnant and lactating women, previous treatment with Efavirenz, positive history of neuropyschiatric disorders such as severe depression, patients who are receiving mood affecting agents (such as Methadone), positive history of hypersensitivity to herbal products including Valerian, discontinuation of antiretroviral therapy by patient due to any reason, patients who do not tolerate side effects of Valerian (headache, vertigo, stomach pain, nausea, vomiting, diarrhea and palpitation).
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
None
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Included patients will be assigned to the Valerian or placebo group based on the block randomization method. Randomization and distribution of the Valerian or placebo will be done by the hospital pharmacy department and researchers, physicians and patients will be blinded regarding type of intervention (Valerian or placebo).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods Ave.
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Approval date
2015-11-25, 1394/09/04
Ethics committee reference number
IR.TUMS.REC.1394.1280

Health conditions studied

1

Description of health condition studied
Neuropsychiatric disorders
ICD-10 code
F10-19.5
ICD-10 code description
A cluster of psychotic phenomena that occur during or following drug use

Primary outcomes

1

Description
Depression, Anxiety, Sleep Disturbance. Positive and Negative Suicide Ideation, Positive and Negative Symptoms of Psychosis
Timepoint
At baseline and 4 weeks later
Method of measurement
The Hamilton Depression and Anxiety, Pittsburgh Sleep Quality, Positive and Negative Suicide Ideation, Positive and Negative Symptoms of Psychosis Scales

Secondary outcomes

1

Description
Safety of Valerian
Timepoint
During the study
Method of measurement
Patients reports and follow up

Intervention groups

1

Description
2 capsules of Sedamin ( 530 mg of dry extract of Valerian root- GolDaru Pharmaceutical Company- Isfahan-IRAN) every night 2 hours before bed time for 4 weeks.
Category
Treatment - Drugs

2

Description
2 Capsules of Placebo (GolDaru Pharmaceutical Company- Isfahan-IRAN) every night 2 hours before bed time for 4 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hossein Khalili
Street address
Keshavarz Blvd.
City
Tehran
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Ghods Ave.
City
Tehran
Country
Iran (Islamic Republic of)
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, 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
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 21 6658 1598
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
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 21 6658 1598
Fax
Email
khalilih@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...