Investigation into the effectiveness of Crocus savitus and its active ingredient Crocin as a complementary approach in the treatment of patients with major postpartum depression receiving treatment, using triple blind random clinical trial controlled with placebo, plus assessment of the change in patients' Beck II score.
Investigation of the therapeutical effects of Saffron and Crocin in treatment of post partum depression as an alternative approach
Design
Three arm parallel group design of 45 patients, randomized trial with control
Settings and conduct
The research will be carried out as triple blind, researcher, physician and patients will be unaware, at Mashhad's Ibn Sina hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria; nursing mothers with post partum depression.
Exclusion criteria; hepatic and renal disorder, history of being allergic to saffron, alcohol consumption and drug use
Intervention groups
First intervention group: Take tablets containing 15mg Saffron BID besides main medication for 3 months
Second intervention group: Take tablets containing 5 mg Crocin BID besides main medication for 3 months
Third intervention group: Control group with pelacbo's besides main medication for 3 months
Main outcome variables
Assessment of the treatment according to changes in Beck2's score average
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130826014477N5
Registration date:2018-08-01, 1397/05/10
Registration timing:prospective
Last update:2018-08-01, 1397/05/10
Update count:0
Registration date
2018-08-01, 1397/05/10
Registrant information
Name
Zhila Taherzadeh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1882 3255
Email address
taherzadehzh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-06, 1397/05/15
Expected recruitment end date
2019-06-05, 1398/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation into the effectiveness of Crocus savitus and its active ingredient Crocin as a complementary approach in the treatment of patients with major postpartum depression receiving treatment, using triple blind random clinical trial controlled with placebo, plus assessment of the change in patients' Beck II score.
Public title
Comparison between the effectiveness of Crocus sativus and Crocin in the treatment of patients with major postpartum depression under common medical care.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Nursing mothers after their delivery up to the passage of six months
Nursing mothers in the 18-50 age range
Delivery of full-term, healthy, singleton baby
Acceptance of completion of the informed consent form after providing the necessary information on the investigation
Obtaining of an exact diagnosis of the major depressive disorder using Edinburgh questionnaire by a psychiatrist during a clinical examination
Exclusion criteria:
Patients with a history of chronic, systemic diseases
Patients with a history of medical disorders such as preeclampsia and diabetes
Patients allergic to saffron
Smoking cigarettes, drinking alcohol and taking drugs
Patients with a history hepatic and renal disorders
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, individual, unstratified randomization using randomization website's random number list and sealed envelope
Blinding (investigator's opinion)
Triple blinded
Blinding description
After all the patients are diagnosed as suffering from postpartum depression by a psychiatrist, they are divided randomly into three groups by an academic individual with knowledge of scientific methods not taking part in the investigation, and their sealed envelope of medications for a period of two weeks and Beck II questionnaire are distributed among the patients by another individual other than the investigator, clinical health care provider and outcome analyst, then the collected data is handed to the investigator.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
School of pharmacy, Pardis university campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
917751365
Approval date
2018-05-12, 1397/02/22
Ethics committee reference number
IR.MUMS.REC.1397.043
Health conditions studied
1
Description of health condition studied
major postpartum depression
ICD-10 code
F53.1
ICD-10 code description
Severe mental and behavioural disorders associated with the puerperium, not elsewhere classified Puerperal psychosis NO
Primary outcomes
1
Description
Change in mean score of BDI-II
Timepoint
Every two weeks for12 weeks
Method of measurement
BDI_II Questionnaire
Secondary outcomes
1
Description
Investigation on alternative medicine on females' sexual function
Timepoint
Beginning of intervention and end of every months
Method of measurement
FSFI Questionnaire
2
Description
Monitor of, investigation into and finding evidence for completing probable adverse effects of using Corcus Sativus and Crocin in nursing mothers to add to drug's information in herbal pharmacopeia
Timepoint
Beginning of intervention and end of every months during patient's visit for a period of twelve weeks
Method of measurement
Observation and clinical examination of the patient
3
Description
Examining patients' response to the alternative medicine
Timepoint
At the end of intervention
Method of measurement
Assessment of patients' number with fifty percent decrease in average score Beck II questionnaire in comparison with the base line
4
Description
Examining patient's remission under treatment
Timepoint
The end of intervention
Method of measurement
Assessment of patients' number with seventy percent decrease in average score Beck II questionnaire in comparison with the base line
5
Description
Assessment of the effects of such interfering factors as age, treatment protocol, type of delivery and etc.
Timepoint
The end of intervention
Method of measurement
Statistical analysis of collected data with SPSS software
Intervention groups
1
Description
Control group: Using placebo alongside the patient's main drug regimen
Category
Placebo
2
Description
Second intervention group: Tablets containing five mg Crocin (prepared in the Pharmacy faculty of Mashhad Medical University) taken orally twice a day for three months
Category
Treatment - Drugs
3
Description
First intervention group: Tablets containing fifteen mg saffron (prepared in the Pharmacy faculty of Mashhad Medical University using Mashhad Saharkhiz company's saffron) taken orally twice a day for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina psychiatry training hospital
Full name of responsible person
Fatemeh Behdani
Street address
Ibn Sina hospital, Hor Ameli Street, Adjacent to Astan Qods' transport
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3711 2701
Fax
+98 51 3711 2545
Email
behdanif@mums.ac.ir
Web page address
http://sina.mums.ac.ir/index.php
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
School of pharmacy, Pardis university campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3882 3255
Email
tafaghodim@mums.ac.ir
Web page address
http://www.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
90
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
Mashhad University of Medical Sciences
Full name of responsible person
Zhila Taherzadeh
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical pharmacology
Street address
School of pharmacy, Pardis university campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 1882 3255
Fax
+98 51 1882 3251
Email
taherzadehzh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zhila Taherzadeh
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical pharmacology
Street address
Pharmacodynamics and Toxicology Group, School of Pharmacy, Medical Science University of Mashhhad, Vakil Abad Blvd, Mashhad
City
Mhahhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3882 3255
Fax
Email
taherzadehzh@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Khajavian
Position
Pharmacy student
Latest degree
Bachelor
Other areas of specialty/work
Medical Pharmacy
Street address
School of pharmacy, Pardis university campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3663 5986
Email
khajavianz921@mums.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
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
After the participants' identities are obscured, all the data are publitionable.
When the data will become available and for how long
The finalized data begin to be available for access after the research is finished.
To whom data/document is available
All the data are available to be sent to the applicants if their request is confirmed.
Under which criteria data/document could be used
Universities' and researchers permission
From where data/document is obtainable
To the faculty member who is the trials' operator
taherzadehzh@mums.ac.ir
09158867923
What processes are involved for a request to access data/document
Sending of the written request
Attainment of approval from the university and the involved faculty member