Efficacy of a herbal syrup containing Lavandula angustifolia and Cuscuta chinensis versus citalopram in MDD with anxious distress, a double blind randomized clinical trial
The aim of this investigation is to assess the efficacy of a herbal syrup containing Lavender and Chinese dodder versus Citalopram in the treatment of Major Depression, with anxious distress. This study is a six-week, single centered, double-blinded, randomized controlled trial. Fifty adult outpatients meeting the DSM- 5 criteria for mild major depression, with anxious distress will participate in the trial. Patients who have a baseline Hamilton Rating Scale for Depression score below 18 and a Hamilton Rating Scale for Anxiety score below 24 will be randomly allocated into two groups. The experimental group with 25 patients will receive Citalopram 20 mg/day and 5 cc of a placebo syrup every 12 hours. The control group with 25 patients will receive 5 cc of herbal syrup every 12 hours with a placebo tablet once a day. Patients will be assessed by a psychiatrist at baseline and by a psychiatric resident at weeks 3 and 6 after starting the medication. Efficacy will be defined as the change from baseline to endpoint in Hamilton Rating Scale scores for Depression and Hamilton Rating Scale scores for anxiety.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102430459N1
Registration date:2016-12-26, 1395/10/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-26, 1395/10/06
Registrant information
Name
Toktam Sadat Firoozeei
Name of organization / entity
School of Traditional Medicine, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6697 6527
Email address
t-firoozeei@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of a herbal syrup containing Lavandula angustifolia and Cuscuta chinensis versus citalopram in MDD with anxious distress, a double blind randomized clinical trial
Public title
Efficacy of a herbal syrup containing Lavander and Chinese dodder in the treatment of Major Depressive Disorder, with anxious distress
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Age between 18 to 60 years old
2. Presence of Major Depressive Disorder, with anxious distress based on DSM-5 criteria
3. Scores lower than 18 in the Hamilton Rating Scale for Depression.
4. Scores lower than 24 in the Hamilton Rating Scale for Anxiety
Exclusion criteria:
1. The presence of psychotic symptoms, current or past history of Bipolar disorder, Schizophrenia and Schizotypal personality disorder
2. Receiving psychotropic medications or any antidepressants during the past 14 days
3. The presence of an unstable disorder, Kidney or Liver failure, malignancy, Thyroid problems, Diabetes, past history of Epilepsy, bleeding disorders
4. Nursing and pregnant women, reproductive age without a contraception method
5. Substance abuse or addiction in the past 3 months
6. Suicidal tendency in the past year, scores greater than 2 on the Suicide item of the Hamilton Rating Scale for Depression
7. Women who are receiving OCP
8. Any clinically significant deterioration in the condition of the subject from baseline detected by the attending physician
9. Current or past history of Cognitive disorder in the past year
10. ECT during the past 3 months
11. Psychotherapy in the past month
12. A past history of allergy towards Lavender, Chinese dodder and Citalopram
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Tehran University of Medical Sciences
Street address
Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2016-10-08, 1395/07/17
Ethics committee reference number
IR.TUMS.VCR.REC.1395.736
Health conditions studied
1
Description of health condition studied
Depressive episode
ICD-10 code
F32.0
ICD-10 code description
Mild depressive episode
Primary outcomes
1
Description
Severity of depression
Timepoint
Baseline, weeks 3 and 6 after starting treatment
Method of measurement
Hamilton Depression Rating Scale
Secondary outcomes
1
Description
Anxiety
Timepoint
Baseline, weeks 3 and 6 after starting treatment
Method of measurement
Hamilton Anxiety Rating Scale
Intervention groups
1
Description
Experimental group: tab citalopram 20 mg/day and 5 cc of a placebo syrup every 12 hours for 6 weeks.
Category
Treatment - Drugs
2
Description
Control group: 5 cc of herbal syrup containing lavender and Chinese dodder every 12 hours with a placebo tablet once a day for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Dr Toktam Sadat Firoozeei
Street address
Isfahan Province, Isfahan, Kashani Street
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, School of Traditional Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Roja Rahimi
Street address
School of Traditional Medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, School of Traditional Medicine, Tehran University of Medical Sciences
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
School of Traditional Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Toktam Sadat Firoozeei
Position
PhD candidate of Traditional Medicine
Other areas of specialty/work
Street address
School of Traditional Medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
City
Tehran
Postal code
1449614353
Phone
+98 21166976527
Fax
Email
t-firoozeei@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Traditional Medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr Hossein Rezaeizadeh
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Traditional Medicine, Tehran University of Medical Sciences, SarParast St., Taleghani St., ValiAsr Blvd.
City
Tehran
Postal code
1449614353
Phone
+98 21 6697 6527
Fax
Email
rezaeizadeh@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)