This study was carried out to determine the effect of hydro alcoholic extract of Mentha Pipperita or Mint (Lamiaceae family) as a complementary treatment on the severity of depressive disorder. This is a triple blind randomized clinical trial was carried out on depressed patients referred to Shahid Mofateh Clinic of Yasouj city during 2007-2008. A total of 120 patients were randomly divided into 5 equal groups to receive placebo, or 10 mg, 50 mg, 100 mg or 200 mg hydro alcoholic extract of Mentha Pipperita for two months. After this period, the severity of depression of the patients was evaluated by BDI and DSM IV-TR criteria and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011105147N1
Registration date:2011-01-13, 1389/10/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-13, 1389/10/23
Registrant information
Name
Nazir Hashemi Mohammad Abad
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 1222 4696
Email address
n-hashemi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasouj University of Medical Sciences
Expected recruitment start date
2007-04-20, 1386/01/31
Expected recruitment end date
2008-04-20, 1387/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Hydro alcoholic Extract of Mentha Piperita (Mint) as a Complementary Treatment on the severity of Depressive Disorder
Public title
The effect of Hydro alcoholic Extract of Mentha Piperita (Mint) as a Complementary Treatment on the severity of Depressive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-60 years, having depressive symptoms for at least two weeks, having a similar treatment except extract Mentha Pipperita
Exclusion criteria: Other psychological disorder, history of admission in psychiatry ward, receiving treatment by ECT (electroconvulsive therapy), history of using any drug except antidepressant drug by psychiatrist in this research
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yasouj University of Medical Sciences, Ethics committee
Street address
Yasouj University of Medical Sciences, Bahonar boulevard, Yasouj
City
Yasouj
Postal code
Approval date
2006-12-09, 1385/09/18
Ethics committee reference number
85918-14
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive disorder
Primary outcomes
1
Description
Severity of depression
Timepoint
Baseline and 2 months after intervention
Method of measurement
Beck Depression Inventory (BDI) and psychiatry interview by DSM IV-TR
Secondary outcomes
empty
Intervention groups
1
Description
Oral mint capsule, 100 mg, once daily for two month
Category
Treatment - Drugs
2
Description
Oral mint capsule, 10 mg, once daily for two month
Category
Treatment - Drugs
3
Description
Oral mint capsule, 50 mg, once daily for two month
Category
Treatment - Drugs
4
Description
Oral mint capsule, 200 mg, once daily for two month
Category
Treatment - Drugs
5
Description
Placebo oral capsule, once daily for two month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofate Clinic of Yasouj
Full name of responsible person
Nazir Hashemi Mohammad Abad
Street address
No 19, 5 Bahonar, Oghab square, Yasouj
City
Yasouj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research
Full name of responsible person
Nazir Hashemi Mohammad Abad
Street address
NO 19, 5 Bahonar, Oghab Square, Yasouj
City
Yasouj
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
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
Yasouj University of Medical Sciences
Full name of responsible person
Nazir Hashemi Mohammad Abad
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
No 19, 5 Bahonar, Oghab Square, Yasouj
City
Yasouj
Postal code
Phone
+98 74 1222 4696
Fax
Email
n-hashemi@yums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Nazir Hashemi Mohammad Abad
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
No 19, 5 Bahonar, Oghab Square, Yasouj
City
Yasouj
Postal code
Phone
+98 74 1222 4696
Fax
Email
n-hashemi@yums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Nazir Hashemi Mohammad Abad
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
No 19, 5 Bahonar, Oghab Square, Yasouj
City
Yasouj
Postal code
Phone
+98 74 1222 4696
Fax
Email
n-hashemi@yums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)