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Protocol summary
Evaluation the efficacy of a syrup of Echium Amoenum-Melissa Officinalis in treatment of children and adolescents with mild to moderate Obsessive-Compulsive Disorder
Evaluation the efficacy of a syrup of Echium Amoenum-Melissa Officinalis in treatment of adolescents with Obsessive-Compulsive Disorder
Evaluation the efficacy of a syrup of Echium Amoenum-Melissa Officinalis in treatment of children and adolescents with mild to moderate Obsessive-Compulsive Disorder
بررسی اثر شربت گاوزبان-بادرنجبویه در درمان کودکان و نوجوانان مبتلا به اختلال وسواس فکری-عملی خفیف تا متوسط
بررسی اثر شربت گاوزبان-بادرنجبویه در درمان نوجوانان مبتلا به اختلال وسواس فکری-عملی
بررسی اثر شربت گاوزبان-بادرنجبویه در درمان کودکان و نوجوانان مبتلا به اختلال وسواس فکری-عملی خفیف تا متوسط
Inclusion criteria:
Obsessive-Compulsive Disorder with a diagnosis of pediatric psychiatry according to DSM-5 criteria; Severity of Obsessive-Compulsive Disorder scale 10 to 25 (based on Yale Brown Obsessive-Compulsive Questionnaire in Children); Ages 8 to 17 years
Exclusion criteria:
Psychosis; Bipolar disorder; Catatonic symptoms; Drug abuse; Severe or debilitating illnesses; Phenobarbital consumption; Oxazepam consumption; Sedative drugs consumption
Inclusion criteria:
Obsessive-Compulsive Disorder with a diagnosis of pediatric psychiatry according to DSM-5 criteria; Ages 13 to 17 years
Exclusion criteria:
Psychosis; Bipolar disorder; Catatonic symptoms; Drug abuse; Severe or debilitating illnesses; Phenobarbital consumption; Oxazepam consumption; Sedative drugs consumption
Inclusion criteria: Obsessive-Compulsive Disorder with a diagnosis of pediatric psychiatry according to DSM-5 criteria; Severity of Obsessive-Compulsive Disorder scale 10 to 25 (based on Yale Brown Obsessive-Compulsive Questionnaire in Children); Ages 813 to 17 years Exclusion criteria: Psychosis; Bipolar disorder; Catatonic symptoms; Drug abuse; Severe or debilitating illnesses; Phenobarbital consumption; Oxazepam consumption; Sedative drugs consumption
شرایط ورود: وجود اختلال وسواس فكري-عملي با تشخیص فوق تخصص روانپزشکی اطفال و بر اساس معیارهایDSM-5؛ نمره شدت اختلال وسواس فکری-عملی 10 تا 25 (بر اساس پرسش نامه وسواس فکری–عملی ییل براون در کودکان)؛ سن 8 تا 17 سال
شرایط عدم ورود به مطالعه: ابتلا به سايكوز؛ ابتلا به اختلال دو قطبي؛ وجود علائم کاتاتونی؛ سوءمصرف مواد؛ بیماری های شدید یا ناتوان کننده جسمانی؛ مصرف فنوباربیتال؛ مصرف اگزازپام؛ مصرف داروهای سداتیو
شرایط ورود: وجود اختلال وسواس فكري-عملي با تشخیص فوق تخصص روانپزشکی اطفال و بر اساس معیارهایDSM-5؛ سن 13 تا 17 سال
شرایط عدم ورود به مطالعه: ابتلا به سايكوز؛ ابتلا به اختلال دو قطبي؛ وجود علائم کاتاتونی؛ سوءمصرف مواد؛ بیماری های شدید یا ناتوان کننده جسمانی؛ مصرف فنوباربیتال؛ مصرف اگزازپام؛ مصرف داروهای سداتیو
شرایط ورود: وجود اختلال وسواس فكري-عملي با تشخیص فوق تخصص روانپزشکی اطفال و بر اساس معیارهایDSM-5؛ نمره شدت اختلال وسواس فکری-عملی 10 تا 25 (بر اساس پرسش نامه وسواس فکری–عملی ییل براون در کودکان)؛ سن 813 تا 17 سال شرایط عدم ورود به مطالعه: ابتلا به سايكوز؛ ابتلا به اختلال دو قطبي؛ وجود علائم کاتاتونی؛ سوءمصرف مواد؛ بیماری های شدید یا ناتوان کننده جسمانی؛ مصرف فنوباربیتال؛ مصرف اگزازپام؛ مصرف داروهای سداتیو
General information
8
13
813
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40
40
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2020-01-21, 1398/11/01
2020-01-21 00:00:00
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2021-01-27, 1399/11/08
2021-01-27 00:00:00
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2021-03-25, 1400/01/05
2021-03-25 00:00:00
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Need to limit the target group to adolescents to standardize the dose of the drug; Inclusion of all adolescents with obsessive-compulsive disorder (of varying severity) in the study
Need to limit the target group to adolescents to standardize the dose of the drug; Inclusion of all adolescents with obsessive-compulsive disorder (of varying severity) in the study
empty
نیاز به محدود کردن گروه هدف به نوجوانان در جهت یکسان سازی دوز دارو، ورود کلیه نوجوانان مبتلا به وسواس فکری عملی (با شدت های مختلف) در مطالعه
نیاز به محدود کردن گروه هدف به نوجوانان در جهت یکسان سازی دوز دارو، ورود کلیه نوجوانان مبتلا به وسواس فکری عملی (با شدت های مختلف) در مطالعه
Evaluation the efficacy of a syrup of Echium amoenum-Melissa officinalis in treatment of children and adolescents with Obsessive-Compulsive Disorder
Evaluation the efficacy of a syrup of Echium amoenum-Melissa officinalis in treatment of adolescents with Obsessive-Compulsive Disorder
Evaluation the efficacy of a syrup of Echium amoenum-Melissa officinalis in treatment of children and adolescents with Obsessive-Compulsive Disorder
بررسی اثر شربت گاوزبان–بادرنجبویه در درمان کودکان و نوجوانان مبتلا به اختلال وسواس فکری-عملی
بررسی اثر شربت گاوزبان–بادرنجبویه در درمان نوجوانان مبتلا به اختلال وسواس فکری-عملی
بررسی اثر شربت گاوزبان–بادرنجبویه در درمان کودکان و نوجوانان مبتلا به اختلال وسواس فکری-عملی
Evaluation the efficacy of a syrup of Echium amoenum-Melissa officinalis in treatment of children and adolescents with mild to moderate Obsessive-Compulsive Disorder
Evaluation the efficacy of a syrup of Echium amoenum-Melissa officinalis in treatment of adolescents with Obsessive-Compulsive Disorder
Evaluation the efficacy of a syrup of Echium amoenum-Melissa officinalis in treatment of children and adolescents with mild to moderate Obsessive-Compulsive Disorder
بررسی اثر شربت گاوزبان–بادرنجبویه در درمان کودکان و نوجوانان مبتلا به اختلال وسواس فکری-عملی خفیف تا متوسط
بررسی اثر شربت گاوزبان–بادرنجبویه در درمان نوجوانان مبتلا به اختلال وسواس فکری-عملی
بررسی اثر شربت گاوزبان–بادرنجبویه در درمان کودکان و نوجوانان مبتلا به اختلال وسواس فکری-عملی خفیف تا متوسط
Obsessive-Compulsive Disorder with a diagnosis of pediatric psychiatry according to DSM-5 criteria
Severity of Obsessive-Compulsive Disorder scale 10 to 25 (based on Yale Brown Obsessive-Compulsive Questionnaire in Children)
Ages 8 to 17 years
Obsessive-Compulsive Disorder with a diagnosis of pediatric psychiatry according to DSM-5 criteria
Ages 13 to 17 years
Obsessive-Compulsive Disorder with a diagnosis of pediatric psychiatry according to DSM-5 criteria Severity of Obsessive-Compulsive Disorder scale 10 to 25 (based on Yale Brown Obsessive-Compulsive Questionnaire in Children) Ages 813 to 17 years
وجود اختلال وسواس فكري-عملي با تشخیص فوق تخصص روانپزشکی اطفال و بر اساس معیارهایDSM-5
نمره شدت اختلال وسواس فکری-عملی 10 تا 25 (بر اساس پرسش نامه وسواس فکری–عملی ییل براون در کودکان)
سن 8 تا 17 سال
وجود اختلال وسواس فكري-عملي با تشخیص فوق تخصص روانپزشکی اطفال و بر اساس معیارهایDSM-5
سن 13 تا 17 سال
وجود اختلال وسواس فكري-عملي با تشخیص فوق تخصص روانپزشکی اطفال و بر اساس معیارهایDSM-5 نمره شدت اختلال وسواس فکری-عملی 10 تا 25 (بر اساس پرسش نامه وسواس فکری–عملی ییل براون در کودکان) سن 813 تا 17 سال
Protocol summary
Study aim
Evaluation the efficacy of a syrup of Echium Amoenum-Melissa Officinalis in treatment of adolescents with Obsessive-Compulsive Disorder
Design
Randomized clinical trial, including intervention and control groups with parallel groups, double-blind
The random allocation sequence using the random number table is www.randomization.com.
The method of allocation concealment: indoor envelopes. The sample size is 20 people in each group.
Settings and conduct
Recruitment center: Child Psychaitry clinic at Ibn-e-Sina hospital
Patients are evaluated by pediatric psychiatrist with Yale Brown Obsessive-Compulsive questionnaire in children and divided into intervention and control groups by simple randomization method. Patients and outcome assessors are unaware of the individuals assigned to the groups.The Yale Brown Obsessive-Compulsive questionnaire for Children is administered in week 4 and 8 of the study and questionnaires of quality of life, Anxiety, and Depression are completed at the beginning and end of the study for patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Obsessive-Compulsive Disorder with a diagnosis of pediatric psychiatry according to DSM-5 criteria; Ages 13 to 17 years
Exclusion criteria:
Psychosis; Bipolar disorder; Catatonic symptoms; Drug abuse; Severe or debilitating illnesses; Phenobarbital consumption; Oxazepam consumption; Sedative drugs consumption
Intervention groups
Intervention group will receive a herbal syrup, 0.3 milliliter per kilogram of body weight and 50 mg Fluvoxamine tablets daily and the control group will receive placebo syrup and 50 mg Fluvoxamine tablets daily for 8 weeks.
Main outcome variables
Obsessive score on children's Yale-Brown Obsessive Compulsive questionnaire
General information
Reason for update
Need to limit the target group to adolescents to standardize the dose of the drug; Inclusion of all adolescents with obsessive-compulsive disorder (of varying severity) in the study
Acronym
IRCT registration information
IRCT registration number:IRCT20191127045521N1
Registration date:2019-12-05, 1398/09/14
Registration timing:prospective
Last update:2021-05-12, 1400/02/22
Update count:1
Registration date
2019-12-05, 1398/09/14
Registrant information
Name
Maryam Hosseini Abrishami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 8931
Email address
hoseiniam951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
2020-01-21, 1398/11/01
Actual recruitment end date
2021-01-27, 1399/11/08
Trial completion date
2021-03-25, 1400/01/05
Scientific title
Evaluation the efficacy of a syrup of Echium amoenum-Melissa officinalis in treatment of adolescents with Obsessive-Compulsive Disorder
Public title
Evaluation the efficacy of a syrup of Echium amoenum-Melissa officinalis in treatment of adolescents with Obsessive-Compulsive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obsessive-Compulsive Disorder with a diagnosis of pediatric psychiatry according to DSM-5 criteria
Ages 13 to 17 years
Exclusion criteria:
Psychosis
Bipolar disorder
Catatonic symptoms
Drug abuse
Severe or debilitating illnesses
Phenobarbital consumption
Oxazepam consumption
Sedative drugs consumption
Age
From 13 years old to 17 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into Intervention and control groups using simple randomization (www.randomization.com). How to hide the allocation is with closed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients in this study are unaware that they are assigned to a control or intervention group. Intervention group will receive Echium amoenum-Melissa officinalis syrup and fluoxamine tablets. Control group will receive placebo and fluoxamine tablets.The outcome assessor is also unaware of which group the patient belongs to.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Mashhad Univercity Of Medical Sciences, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2019-09-21, 1398/06/30
Ethics committee reference number
IR.MUMS.REC.1398.221
Health conditions studied
1
Description of health condition studied
Obsessive-Compulsive Disorder
ICD-10 code
F42.2
ICD-10 code description
Mixed obsessional thoughts and acts
Primary outcomes
1
Description
Obsessive score on children's Yale-Brown Obsessive Compulsive questionnaire
Timepoint
pretest, 4 weeks after beginning, post-test (at the end of 8 weeks)
The World Health Organization Quality of Life Questionnaire
2
Description
Anxiety score
Timepoint
pretest, 4 weeks after beginning, post-test (at the end of 8 weeks)
Method of measurement
Spence Children's Anxiety Questionnaire
3
Description
Depression score
Timepoint
pretest, 4 weeks after beginning, post-test (at the end of 8 weeks)
Method of measurement
Maria Kovas Depression Questionnaire
Intervention groups
1
Description
Intervention group will receive a Echium amoenum-Melissa officinalis syrup, 0.3 milliliter per kilogram of body weight and 50 mg Fluvoxamine tablets daily for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group will receive placebo syrup and 50 mg Fluvoxamine tablets daily for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Child Psychaitry clinic at Ibn-e-Sina hospital
Full name of responsible person
Dr. Atefeh Soltanifar
Street address
Ibn-e-Sina psychiatric Hospital, Horre ameli avenue, Boo Ali square
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Fax
+98 51 3711 2545
Email
soltanifara@mums.ac.ir
Web page address
http://sina.mums.ac.ir/index.php
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Web page address
http://v-research.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
Maryam Hosseini Abrishami
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional and Compelementary Medicine, Ferdosi University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
Hoseiniam951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Noras
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional and Compelementary Medicine, Ferdosi University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3882 9279
Email
norasmr@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Hosseini Abrishami
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
School of Traditional and Compelementary Medicine, Ferdosi University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3884 8931
Email
Hoseiniam951@mums.ac.ir
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