Assessment of Withania somnifera root extract adequacy in patients with generalized anxiety disorder: A randomized, double-blind, placebo-controlled trial
The aim of this study is to assess the adequacy of W. somnifera root extract as an alternative therapy to standard GAD treatment.
Design
Forty patients were randomly selected for participation in the treatment group (W. somnifera extract, 1g/day; n = 22) or the placebo group (n = 18).
Settings and conduct
This general anxiety study was conducted at the site of Ibn Sina Hospital as a double blind controlled clinical trial in 2015. Patients and researchers (physician) did not know the type of intervention group.
Participants/Inclusion and exclusion criteria
The GAD patients according to DSM-IV-TR who had been under the treatment of SSRI drugs were included. Exclusion criteria were pregnancy and lactation, comorbidity with other acute psychological disorders, drug abuse and physical disorders which cause anxiety.
Intervention groups
treatment group (W. somnifera extract, 1g/day; n = 22) or the placebo group (n = 18). All patients were under treatment with Selective Serotonin Re-uptake Inhibitors (SSRIs), and were prescribed 1 capsules of the extract or placebo per day for six weeks
Main outcome variables
The Hamilton anxiety rating scale (HAM-A) was used in order to assess the severity of GAD symptoms at baseline and at the second and sixth week of the trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180615040105N1
Registration date:2018-07-03, 1397/04/12
Registration timing:retrospective
Last update:2018-07-03, 1397/04/12
Update count:0
Registration date
2018-07-03, 1397/04/12
Registrant information
Name
Asieh Karimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3705 4262
Email address
karimania921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
2014-08-23, 1393/06/01
Actual recruitment end date
2016-07-27, 1395/05/06
Trial completion date
empty
Scientific title
Assessment of Withania somnifera root extract adequacy in patients with generalized anxiety disorder: A randomized, double-blind, placebo-controlled trial
Public title
effect of Withania somnifera root extract in generalized anxiety disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosed as GAD patients according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
they had to be under the treatment of SSRI drugs with adequate dose and duration
Exclusion criteria:
pregnancy and lactation
comorbidity with other acute psychological disorders
drug abuse and physical disorders which cause anxiety
every accident such as death or immigration
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization was done by use of computer generated random numbers.
Investigators and participants were unaware of upcoming allocations.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medication and placebo were prepared in capsule form and in a similar way at the Faculty of Pharmacy, so that the patient and the evaluator (physicians) did not know the specific intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of mashhad University of Medical Sciences
Street address
Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2014-07-26, 1393/05/04
Ethics committee reference number
IR.MUMS.REC.1393.137
Health conditions studied
1
Description of health condition studied
generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety score in Hamilton Test
Timepoint
At the onset of the study (before the intervention) and weeks 2, 6
Method of measurement
Anxiety Evaluation by Hamilton Test
Secondary outcomes
1
Description
quality life score
Timepoint
the onset of the study, second and sixth week
Method of measurement
Score based on Hamilton test
Intervention groups
1
Description
Intervention group: 22 patients received one capsule wich contains 1 g W. somnifera extract/day for six weeks.
Category
Treatment - Other
2
Description
Control group:18 patients received placebo (simillar capsule filled with lactose), one capsule/day for six weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibne ُُSina hospital
Full name of responsible person
Ali Akhondpour Manteghi
Street address
Psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3711 2540
Email
Mohamadpoorah@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3883 9794
Email
mohamadpoorah@mums.ac.ir
Grant name
Grant code / Reference number
922815
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Asieh Karimani
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 7, yazdi Ave., ferdowsi Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3705 4262
Fax
Email
karimania921@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Asieh Karimani
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No. 7, yazdi Ave., ferdowsi Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3705 4262
Fax
Email
karimania921@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Asieh Karimani
Position
resident
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
psychiatry and Behavioral Sciences Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9198955878
Phone
+98 51 3705 4232
Email
karimania921@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data, such as information on the main consequence of the protective agent, can be used
When the data will become available and for how long
Start the access period from 1398
To whom data/document is available
for all the investigators
Under which criteria data/document could be used
Researchers for further studies
From where data/document is obtainable
ِDr. Ali Akhondpour Manteghi
manteghia@mums.ac.ir
What processes are involved for a request to access data/document
Immediately after reviewing the terms of the applicant