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Evaluation of the effect of the hydroalcoholic extract of the plant Dracocephalum kotschyi Boiss. on the severity of depression in patients referred to psychiatric clinic

Protocol summary

Study aim
Comparison of the severity of depression before and after taking the hydroalcoholic extract of Danai Dracocephalum kotschyi Boiss plant in patients referred to the psychiatric clinic.
Design
A clinical trial with a control group, with parallel groups, without blinding, non-random, phase 3 on 74 patients, the collected data will be entered into the computer and will be analyzed by spss software version 25.
Settings and conduct
In the control group, S-Citalopram tablets, 10 mg daily, for 1 month, and in the intervention group, in addition to the same dose of S-Citalopram, a dose of 500 mg of the hydroalcoholic extract of the studied plant (one daily capsule) was given by a specialist doctor after explanation. The exact method of use is given to the patient. Patients are visited and medicine is prescribed in Shahid Muftah educational and therapeutic clinic. The participants take the medicines at home and The place of study is Yasouj University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of mild to moderate depression based on clinical interview and depression questionnaire Exclusion criteria: Contraindications for taking extract of Danai Dracocephalum kotschyi Boiss plant (such as allergy to herbal medicine)
Intervention groups
The Beck and Hamilton Depression Questionnaire is completed at time zero (before the intervention) and 30 days after the start of treatment for all patients. In the control group, S-citalopram tablets , 10 mg daily, for 1 month, and in the intervention group, in addition to the same dose of S-citalopram, a dose of 500 mg of the hydroalcoholic extract of the studied plant (one daily capsule) was administered by a specialist doctor after explanation. The exact method of use is given to the patient. . 1 month after the treatment, re-evaluation (post-test) is done using the Beck and Hamilton Depression Questionnaire.
Main outcome variables
The level of depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240527061917N1
Registration date: 2024-06-02, 1403/03/13
Registration timing: prospective

Last update: 2024-06-02, 1403/03/13
Update count: 0
Registration date
2024-06-02, 1403/03/13
Registrant information
Name
Fatemeh Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 4829
Email address
fatemehkarimi728@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-01, 1403/05/11
Expected recruitment end date
2024-09-01, 1403/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of the hydroalcoholic extract of the plant Dracocephalum kotschyi Boiss. on the severity of depression in patients referred to psychiatric clinic
Public title
Evaluation of the effect of extract of the plant Dracocephalum kotschyi Boiss on depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of mild to moderate depression based on clinical interview and Beck Depression Questionnaire (score 10 to 29) Consent to participate in the research Age between 18 and 65 Not having underlying diseases affecting depression, including cancer Not having schizophrenia-schizoaffective or psychosis
Exclusion criteria:
Contraindications for taking extract of the plant Dracocephalum kotschyi Boiss (such as allergy to herbal medicine) Suicidal thoughts Contraindications for the use of Citalopram A general medical illness that occurs during the study and leads to not continuing the study (such as MI) The researcher's sudden notification of each of the non-entry indicators
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Saheli street, Yasuj city, Kohgiluye va Boyrahmas provinance
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591984479
Approval date
2023-12-20, 1402/09/29
Ethics committee reference number
IR.YUMS.REC.1402.154

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode, moderate

Primary outcomes

1

Description
Depression score in Beck depression questionnaire
Timepoint
Before the start of the intervention and 4 weeks after the start of the intervention
Method of measurement
Beck depression questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The group receiving S-Citalopram tablets 10 mg daily, for 1 month, along with 500 mg hydro alcoholic extract of the plant Dracocephalum kotschyi Boiss (one daily capsule)
Category
Treatment - Drugs

2

Description
Control group: The group receiving S citalopram 10 mg tablet daily, for 1 month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Muftah Clinic
Full name of responsible person
Nazir Hashemi Mohammad Abad
Street address
Dastjerdi street, Yasuj city, Kohgiluye va Boyrahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591984479
Phone
+98 917 141 1236
Email
nazir.hashemi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyyed Amin Hosseini Mutlaq
Street address
Research assistant, Yasouj University of Medical Sciences, Shahid Motahari Blvd, Yasuj, Kohgiloyeh va Boyerahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591984479
Phone
+98 74 3334 6078
Email
aminhomo@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research assistant, Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Karimi
Position
Researcher
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahadat 5, Bagherkhan street, city of Yasuj, kohgilouyeh va Boyrahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591984479
Phone
+98 74 3322 4829
Fax
Email
fatemehkarimi728@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Karimi
Position
Researcher
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahadat 5, Bagherkhan street, city of Yasuj, kohgilouyeh va Boyrahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591984479
Phone
+98 74 3322 4829
Fax
Email
fatemehkarimi728@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Karimi
Position
Researcher
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahadat 5, Bagherkhan street, city of Yasuj, kohgilouyeh va Boyrahmad
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591984479
Phone
+98 74 3322 4829
Fax
Email
fatemehkarimi728@gmail.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of data
When the data will become available and for how long
After analyzing the results
To whom data/document is available
Specialists in the field of psychiatry
Under which criteria data/document could be used
In case of keeping trust
From where data/document is obtainable
Via e-mail address fatemehkarimi728@gmail.com
What processes are involved for a request to access data/document
Apply by email
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