The aim of this study is evaluating the effectiveness of hydroalcoholic extract of passiflora incarnata in the treatment of major depressive disorder.
Design
This is a randomized, double-blind, placebo-controlled clinical trial
The total sample size is 70 patients
Settings and conduct
This study will be conducted in Emam Reza clinic in Shiraz
This study is triple blinded.
Participants, care provider, outcome assessor, and analysts will blind
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged at least 18
non-inclusion: pregnancy; breastfeeding; serious and unstable disease; opium addiction; drug or alcohol abuse or dependency; the history of seizure; patients at risk of suicidal attempt; patients with a history of suicide
Intervention groups
Patients in the intervention group will receive 40 drops of hydroalcoholic standard extract of passiflora incarnata orally daily for 8 weeks and placebo group will receive 40 drops of placebo orally daily
Main outcome variables
patients will follow at baseline and with 2 week interval up to the 8 weeks using HAM-D 17 questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141227020441N8
Registration date:2020-02-13, 1398/11/24
Registration timing:prospective
Last update:2020-02-13, 1398/11/24
Update count:0
Registration date
2020-02-13, 1398/11/24
Registrant information
Name
Farzaneh Foroughinia
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3635 9357
Email address
foroughinia@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of Pasipay drop (Passiflora incarnata) in the treatment of minor depressive disorder
Public title
The efficacy of Pasipay drop (Passiflora incarnata) in the treatment of minor depressive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Outpatient depress patients
HAM-D score ≥18
18 years old or more
without other psychiatric disorder
Patients should not have been received psychotropic medications at least 4 weeks before study entry
Exclusion criteria:
pregnancy
planning for pregnancy
breastfeeding
serious and unstable disease
opium addiction
drug or alcohol abuse or dependency
history of seizure
patients at risk of suicidal attempt
history of suicide
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is conducted by the table of random numbers
Blinding (investigator's opinion)
Triple blinded
Blinding description
The triple-blind trial is planned in such a way that the study subjects, observers, and analyzers do not know who is in which group. The patient is identified by a code that is inserted in the envelope, and elsewhere it is clear whether this number is related to the drug or the placebo
Placebo
Used
Assignment
Parallel
Other design features
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 blvd., Shiraz, Iran.
City
Shiraz
Province
Fars
Postal code
71345-1978
Approval date
2019-08-31, 1398/06/09
Ethics committee reference number
IR.SUMS.REC.1398.752
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
Primary outcomes
1
Description
Score of depression by HAM-D17 questionnaire with score<16
Timepoint
At baseline and at the weeks 2, 4, 6 and 8
Method of measurement
HAM-D17 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 drops hydroalcoholic extract of passiflora incarnata orally daily for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: 30 drops placebo orally daily for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza clinic
Full name of responsible person
Farzaneh Froughinia
Street address
Emam Reaza clinic, Namazi sq, Zand blvd
City
Shiraz
Province
Fars
Postal code
۷۱۸۷۹۱۵۹۹۸
Phone
+98 71 3212 7001
Email
foroughinia@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice Chancellor of Research, Shiraz University of Medical Sciences, Zand ave
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
foroughinia@sums.ac.ir
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 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
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Foroughinia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Karafarin srteet, Marvdasht road 5th km
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 7132424128233
Email
foroughinia@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Foroughinia
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Karafarin srteet, Marvdasht road 5th km
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3230 5410
Email
foroughinia@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Foroughinia
Position
Assistant Profesoor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Karafarin street, Marvdasht road 5th km
City
Shiraz
Province
Fars
Postal code
7146864685
Phone
+98 71 3242 4128
Email
foroughinia@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available