The comparison of the efficacy of hydroalcoholic extract of Ocimum basilicum and placebo in treatment of anxiety in depressed patients: A randomized double-blind clinical trial
Investigating the effectiveness of Ocimum basilicum hydroalcoholic extract on anxiety in patients with depression
Design
A clinical trial with a control group, with parallel groups, randomized double-blind, phase 2 and 3 on 60 patients, RAND function in Excel software is used for randomization.
Settings and conduct
Among the patients who referred to Dasghib Psychiatry Clinic (under Fasa University of Medical Sciences) randomly, 60 people who have major depression and also have anxiety problems, if they meet the conditions, after receiving written informed consent, were included in the study. At the beginning of the study, each patient completes 2 questionnaires, including Beck's Depression Severity Questionnaire and Hamilton's Anxiety Severity Index. Both groups will also be given standard medications for treating depression. The intervention group consumes a tablespoon of Ocimum basilicum hydroalcoholic extract every night, and the control group consumes a placebo with a similar appearance. The shape and packaging of the syrups of both groups will be the same, so patients and researchers will not be able to distinguish the drug from the placebo. Patients take a tablespoon of the syrup every night before going to bed. 4 weeks after the start of the treatment, the patients will be visited again and the questionnaires will be completed again.
Participants/Inclusion and exclusion criteria
Entry conditions: People with depression between 18 and 65 years old who score at least 18 in the Hamilton Questionnaire. Non-entry: patients with internal diseases such as heart and lung failure, cancer, etc
Intervention groups
The intervention group will use Ocimum basilicum syrup along with anti-depressants. The control group takes a placebo along with antidepressants.
Main outcome variables
Severity of depression, severity of anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230318057752N1
Registration date:2023-04-11, 1402/01/22
Registration timing:prospective
Last update:2023-04-11, 1402/01/22
Update count:0
Registration date
2023-04-11, 1402/01/22
Registrant information
Name
Kiarash Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3734 0393
Email address
kiarashzare1998@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-24, 1402/02/04
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the efficacy of hydroalcoholic extract of Ocimum basilicum and placebo in treatment of anxiety in depressed patients: A randomized double-blind clinical trial
Public title
Effect of Ocimum basilicum in anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women between 18 and 65 years old
People with major depressive disorder based on DSM 5 criteria
Obtaining a minimum score of 18 in the Hamilton Anxiety Questionnaire
Not taking any new anti-anxiety medication in the last 1 month
Not suffering from significant internal diseases such as heart and lung failure, cancer, vascular disease, rheumatological disease, history of seizures and hypothyroidism, etc.
Not using anticoagulant or anti-platelet drugs such as warfarin, heparin, aspirin, etc.
No drug and alcohol addiction
Exclusion criteria:
Any allergy to Ocimum basilicum and its products
Pregnancy or breastfeeding
Hypersensitivity to specific serotonin re-uptake inhibitor drugs
Patients who will not have proper follow-up
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of participants is based on limited randomization, in which case the number of people in each group will be equal. For this purpose, we will remove 30 white balls and 30 black balls that represent each of the studied groups from the bag without replacement and write down their order. Then we put opaque and sealed envelopes containing black or white coded questionnaires into a box in the same order as the balls are removed. This box will be placed in the place where the researcher is visiting the patients participating in the study, and after the patient enters the study, the envelopes will be delivered to the patients in the same order of placement. After receiving the envelope, people will complete the questionnaires in another room. Medicines and placebos are placed in boxes with the same appearance and sealed in another room and are delivered to them according to the white or black code recorded in the patient's questionnaire. None of the people present in the study will be involved in the randomization and the type of medicine received by the patient. Each part of the study, such as randomization, observation of the color code of the questionnaires, and drug delivery, will be done by someone outside the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the visit of the patients by the psychiatrist, closed transparent envelopes containing the questionnaires will be given to the patients who wish to participate in the study. In another room, the patient will complete the questionnaires inside the envelopes, which have predetermined numbers. The colleague in the room gives the patient a box with the same code as the questionnaire, which contains medicine or placebo. With this method, the researchers will be unaware of the drug or placebo. Due to the similarity between the drug and the placebo, the patient will not know the difference between them. None of the people present in the study will be involved in the randomization and the type of medicine received by the patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Ibn Sina square, Fasa
City
Fasa
Province
Fars
Postal code
7461686688
Approval date
2023-03-15, 1401/12/24
Ethics committee reference number
IR.FUMS.REC.1401.251
Health conditions studied
1
Description of health condition studied
Depression, anxiety
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Depression score in Beck questionnaire
Timepoint
Before starting the study and 4 weeks after taking the drug
Method of measurement
Based on the Beck Depression Questionnaire
2
Description
Anxiety score in Hamilton questionnaire
Timepoint
Before starting the study and 4 weeks after taking the drug
Method of measurement
Based on Hamilton anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For four weeks, he consumes one tablespoon of Ocimum basilicum hydroalcoholic extract syrup at a dose of 220 mg/ml every night. This syrup will be produced by the order of Fasa University of Medical Sciences in the Faculty of Pharmacy of Shiraz University of Medical Sciences.
Category
Treatment - Drugs
2
Description
Control group: For four weeks, he consumes a tablespoon of placebo syrup every night, which has the same shape and packaging as Ocimum basilicum syrup. In order to prepare placebo simple syrup according to the American Pharmacopoeia, 85 grams of sugar is mixed with 100 ml of distilled water (similar to the base of medicinal syrup) and mixed slowly at a temperature of 100 degrees until it becomes uniform and with the help of permitted food coloring It should be the same color as medicinal syrup.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fasa University of Medical Sciences, Dastghib Clinic
Full name of responsible person
Dr. Seyed Amin Kouhpayeh
Street address
Ibn Sina square, Fasa
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶۸۶۶۸۸
Phone
+98 71 5335 0994
Email
info@fums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Akbar Farjadfar
Street address
Ibn Sina square, Fasa
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶۸۶۶۸۸
Phone
+98 71 5335 0994
Email
fums.mansoori@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Kiarash Zare
Position
Expert
Latest degree
Bachelor
Other areas of specialty/work
Laboratory Medicine
Street address
Ibn Sina square, Fasa
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶۸۶۶۸۸
Phone
+98 71 5335 0994
Email
kiarashzare1998@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Seyed Amin Kouhpayeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Ibn Sina square, Fasa
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶۸۶۶۸۸
Phone
0715335099
Email
kouhpayeha@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Kiarash Zare
Position
Expert
Latest degree
Bachelor
Other areas of specialty/work
Laboratory Medicine
Street address
Ibn Sina square, Fasa
City
Fasa
Province
Fars
Postal code
۷۴۶۱۶۸۶۶۸۸
Phone
0715335099
Email
kiarashzare1998@yahoo.com
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
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
Demographic information and clinical trial results
When the data will become available and for how long
6 months after the publication of the article, it will be possible to access the data.
To whom data/document is available
Researchers in all universities of medical sciences
Under which criteria data/document could be used
The applicant should submit her request to the Vice-Chancellor of Research and Technology of Fasa University of Medical Sciences, and if this vice-chancellor and the ethics committee of this university agree, the data will be provided to applicant .
From where data/document is obtainable
Fasa University of Medical Sciences, Vice President of Research and Technology
What processes are involved for a request to access data/document
Approval of the Research and Technology Vice-Chancellor and Ethics Committee of Fasa University of Medical Sciences