The aim of this study is to compare the efficiency of Cuscuta Chinensis with current antidepressant drugs (fluoxetine) in treatment of mild to moderate depression disorder. Sampling will be done among patients over 18 years old with the diagnosis of depression confirmed with 2 psychiatrists based on DSM5 and Beck criteria. The main Exclusion criteria is other underlying psychological disorder like Schizophrenia, schizoaffective, bipolar disorder, psychotic disorder, organic disorder make depression directly like hypothyroidism, pregnancy and lactation, addiction, patients with suicidal thought and the patients, cases who may need electronic convulsive therapy (ECT), being under the treatment of antidepressant on 1 month ago , chronic respiratory disease and past history of drug reaction to Cuscuta. This study is a randomized controlled trial. The intervention and control group receive one herbal drug and the current antidepressant agent, respectively. The treatment of patients evaluate by Beck criteria every 2 weeks for 6 weeks. The duration of intervention is 6 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060722584N1
Registration date:2015-09-07, 1394/06/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-07, 1394/06/16
Registrant information
Name
Azade Kiani
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1230 5884
Email address
kiania@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2015-04-22, 1394/02/02
Expected recruitment end date
2015-08-24, 1394/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of Cuscuta Chinensis versus Fluoxetine on depression in cases with major depression
Public title
The efficacy of Cuscuta Chinensis on depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: patients over 18 with the diagnosis of depression based on DSM5 and Beck criteria, patients with written informed consent.
Exclusion: Other underlying psychological disorder like Schizophrenia, schizoaffective, bipolar disorder, psychotic disorder, organic disorder make depression directly like hypothyroidism, pregnancy lactation, addiction, patients with suicidal thought and the patients. Who may need electronic convulsive therapy (ECT), being under the treatment of antidepressant on 1 month ago, chronic respiratory disease and past history of drug reaction to Cuscuta.
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Double blind included patients and researchers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice chancellor for research, Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Postal code
Approval date
2015-04-20, 1394/01/31
Ethics committee reference number
IR.SUMS.REC.1394.4
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Depression
Timepoint
baseline , after intervention on second,4th and 6th week
Method of measurement
Beck depression inventory
Secondary outcomes
1
Description
Side effect like unusual drug reaction, GI discomfort
Timepoint
During the clinical trial specially on second,4th and 6th week
Method of measurement
By asking the patients
Intervention groups
1
Description
500 mg powder of Fluoxetine ( Exir ) capsules twice in day for 6 weeks
Category
Treatment - Drugs
2
Description
500mg Cuscuta capsule twice in day for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
clinic of Shiraz University of Medical Sciences
Full name of responsible person
Azade kiani
Street address
Faculty of Iranian Traditional Medicine , Faculty of Medicine, Setad
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
Basir hashemi
Street address
Vice chancellor for research, Shiraz University of Medical Science, zand St.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Azade kiani
Position
PhD Student of Iranian Traditional Med
Other areas of specialty/work
Street address
Faculty of Iranian Medicine, Faculty of Medicine, Setad
City
Shiraz
Postal code
Phone
+7 132332366
Fax
Email
Kiania@sums.Ac.irKianiazade@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Ali Firozabadi
Position
Associate Professor of Psychiatry
Other areas of specialty/work
Street address
Building Number 2, Faculty of Med,setad
City
Shiraz
Postal code
Phone
+98 71 3233 7589
Fax
Email
Firozabadiali@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Azade Kiani
Position
Phd Student of Iranian Traditional Med
Other areas of specialty/work
Street address
Faculty of Medicine, setad
City
Shiraz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)