Comparison of the efficacy of acupuncture and medication therapy with drug therapy alone in improving anxiety syndrome in patients referred to the outpatient clinic of Ibn Sina Hospital
Determining the effectiveness of adding acupuncture to the usual treatment of anxiety through clinical evaluation (psychometrics) and laboratory
Design
A clinical trial with a control group, a randomized, two blinded, With parallel groups
Settings and conduct
Patients with anxiety symptom referring to Ibne sina Psychiatric Clinic are divided into three groups. The first group is treated with drug therapy + acupuncture in the second group drug and of placebo acupuncture and the third group of drug therapy alone.
Participants/Inclusion and exclusion criteria
Diagnosis of anxiety disorder (other than phobias) based on examination, age of 18-60 years, non-use of psychotropic substances and other simultaneous psychiatric disorder
Intervention groups
First treatment group: Treatment with sertraline with a dose of 50 mg per day for 8 weeks and 12 sessions of acupuncture
Second intervention group: Treatment with sertraline with a dose of 50 mg per day for 8 weeks
Control group: Treatment with sertraline at a dose of 50 mg / day for 8 weeks and 12 sessions of placebo acupuncture
Main outcome variables
The effect of acupuncture on anxiety syndrome in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181031041511N1
Registration date:2018-12-02, 1397/09/11
Registration timing:registered_while_recruiting
Last update:2018-12-02, 1397/09/11
Update count:0
Registration date
2018-12-02, 1397/09/11
Registrant information
Name
Amir Rezaei ardani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2701
Email address
rezaeia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of acupuncture and medication therapy with drug therapy alone in improving anxiety syndrome in patients referred to the outpatient clinic of Ibn Sina Hospital
Public title
Study of the efficacy of adding acupuncture to drug therapy in patients with anxiety syndrome referring to outpatient clinics of Ibn Sina Hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Detection of anxiety disorder based on examination
No other psychiatric disorder
Non-use of psychotropic substances other than cigarettes
Exclusion criteria:
Use of another drug that may interfere
Unwillingness to attend the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are selected through available sampling. They are randomly assigned to the case and control group according to the random numbers table.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants include the first group of acupuncture and the second group receiving acupuncture, and the patients themselves do not know which group is included. The placebo needle is in such a way that the patient feels it, but the needle is removed from the upper part of the patient instead of entering the patient's body), the principal researcher and the evaluator also identify the patients for acupuncture and do not know which acupuncture or placebo they do ) . Only the acupuncture practitioner is informed of the groups
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
Ibne sina hospital , Hore ameli Ave , Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.MUMS.sm.Rec.1396.239
Health conditions studied
1
Description of health condition studied
Generalized anxiety, social anxiety, panic disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Decrease of 50% of Spielberger test scores of anxiety and decrease of serum cortisol level at the end of 8 weeks compared to control group
Timepoint
The beginning of the study and the Eighth week
Method of measurement
Spielberger Anxiety Inventory and Cortisol Serum Assay
Secondary outcomes
empty
Intervention groups
1
Description
first Intervention group: Intervention group: Treatment with sertraline with a dose of 50 mg per day for 8 weeks and 12 sessions of acupuncture
Category
Treatment - Other
2
Description
Control group: Control group: Treatment with sertraline at a dose of 50 mg / day for 8 weeks and 12 sessions of placebo acupuncture
Category
Treatment - Other
3
Description
Second intervention group: Treatment with sertraline with a dose of 50 mg per day for 8 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibne sina hospital
Full name of responsible person
amir rezaei ardani
Street address
Ibne sina hospital , Hore ameli Ave , mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Email
rezaeia@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
mohsen tafaghodi
Street address
Deputy of Research and Technology University,Opposite no.18, Danshgah Ave,mashhad
City
mashhad
Province
Razavi Khorasan
Postal code
91357-345
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
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
ali khorsand vakilzade
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Acupuncture and Supplement
Street address
Emam reza hospital, Emamreza square , Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2011
Fax
Email
khorsanda@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amir Rezaei ardani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Ibne siana hospital, Hore ameli street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Fax
Email
rezaeia@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
ali sabagh gol
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Ibne siana hospital, Hore ameli street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Fax
Email
sabbagha1@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Spielberger test score and serum cortisol levels
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
All researchers are able to access the study results
Under which criteria data/document could be used
Unidentifiable information is not shared with another organization
From where data/document is obtainable
amir rezaei ardani . rezaeia@mums.ac.ir
What processes are involved for a request to access data/document
Study data is published in the course of the paper and no other personal data is available to applicants