comparing the effect of hydroalcoholic extract of combined plants of Ziziphi jujube and Melissa officinale with escitalopram in the treatment of mild to moderate adult depression
Design
In this non-blinded randomized parallel clinical trial, 80 Patients are allocated randomly with simple sequential allocation in one of the two groups (herbal extract or escitaloperam) and receive the intervention of that group.
Settings and conduct
Adult patients older than 18 years old suffering from mild to moderate depression allocated in one of two groups. The first group will receive a combined alcoholic extract of Ziziphi jujube and Melissa officinale with a dose of 600 milligrams per day and prescribed with 10 milligrams of escitalopram every morning with for three weeks. In the second group 10 milligrams of escitalopram tablet, will be prescribed every morning same as the first group. At the beginning and 3 and 6 weeks later patients visit and severity of depression and rate of improvement checked by Hamilton questionnaire and will be recorded
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adult patients older than 18 years old with mild to moderate depression, having informed consent form
Exclusion criteria: Bipolar disorder, patients with cardiovascular or hepatic disease, history of herbal or medicinal allergy ,pregnant women
Intervention groups
Intervention group : Combined alcoholic extract of Ziziphi jujube and Melissa officinale with a dose of 600 milligrams per day prepared in form of a capsule and prescribed with 10 milligrams of escitalopram tablet every morning with one glass of water for three weeks.
Control group: A tablet of escitalopram with a dose of 10 milligrams will be prescribed every morning with one glass of water for three weeks.
Main outcome variables
improvement of depression symptoms according to Hamilton questionnaire and patient report
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081011001323N28
Registration date:2021-10-22, 1400/07/30
Registration timing:registered_while_recruiting
Last update:2021-10-22, 1400/07/30
Update count:0
Registration date
2021-10-22, 1400/07/30
Registrant information
Name
Sadrollah Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6070
Email address
dr.mehrabi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-21, 1400/05/30
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of Ziziphi jujube and Melissa Officinale extract with Escitalopram on the treatment of adulthood depression
Public title
Comparison effect of Ziziphi jujube and Melissa Officinale extract with Escitalopram on the treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients(older than 18 years old)
Suffering from mild to moderate depression
Having informed consent form
Exclusion criteria:
Suffering from bipolar disorder
Patients with acute psychosis
Patients with cardiovascular disease or hepatic function impairment
Patients with any history of allergy to chemical or herbal drugs
Pregnant women
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated randomly with simple random allocation method by use of random number table to one of each group combined herbal extract or escitalopram) and received the intervention of that group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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, Mottahari srteet, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741414
Approval date
2021-08-17, 1400/05/26
Ethics committee reference number
IR.YUMS.REC.1400.128
Health conditions studied
1
Description of health condition studied
moderate depression
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate
Primary outcomes
1
Description
Improvement of depression symptoms
Timepoint
Before start of treatment,3 and 6 weeks later
Method of measurement
According to Hamilton questionnaire
Secondary outcomes
1
Description
Evaluating drug reactions
Timepoint
During treatment and 3 and 6 weeks next
Method of measurement
According to patient reports and physician examination
Intervention groups
1
Description
Intervention group: Combined alcoholic extract of Ziziphi jujube and Melissa officinale with a dose of 600 milligrams per day prepared in form of capsule and prescribed with 10 milligrams of escitalopram tablet every morning with one glass of water for three weeks.
Category
Treatment - Drugs
2
Description
Control group: Escitalopram tablet in a dose of 10 milligrams of prescribed every morning with one glass of water for three weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofateh clinic of Yasuj
Full name of responsible person
Sadrolleh Mehrabi
Street address
Shahid Mofateh clinic, Montazeri Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 1812
Email
sadrollahm@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Ali Mousavizadeh
Street address
Deputy of research, Yasuj University of Medical Sciences,, Motahari St
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6074
Email
health.epid@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Saied Razmeh
Position
Assistant professor, Neurology Department, Yasuj University of Medical Sciences