This study is a double blind, placebo controlled clinical trial which will be conducted in the clinic of Imam-Khomeini Hospital, Tehran, Iran. 50 patients who meet ACR criteria and inclusion criteria will be recruited. Participants randomly allocated into two groups. Twenty five will receive Duloxetine 30 mg per day during the first week and then 30 mg BID. the other group(25) will receive saffron(15 mg per day in the first week and then 15 mg BID.20 to 40 mg/day and 25 will receive saffron 30 mg/day. Patients were assessed by Breif Pain Index(BPI), Global Fatigue Index and Fibromyalgia Impact Questionnaire (FIQ) at baseline and after 2, 4 6 and 8 weeks after the medication started.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604261556N91
Registration date:2016-07-26, 1395/05/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-26, 1395/05/05
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Saffron Vs doluxetine in the treatment of Fibromyalgia: a randomized , double blind controlled trial
Public title
Saffron Vs duloxetine in the treatment of Fibromyalgia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age at least 18 years old; meeting ACR criteria for Fibromyalgia; severity of pain at least 40 based on visual analogue scale.
Exclusion criteria: receiving Duloxetine at present or in the past; any psychiatric disorder except for MDD; osteoarthritis, multiple sclerosis; history of multiple surgeries, infectious disease, uncontrolled endocine disease, hepatic disease, cardiovascular disease, AIDS, epilepsy, malignancy; pregnancy; nursing women; receiving serotonergic agents or MAOIs; active suicidal thoughts; abuse of alcohol or substances in the previous two years; receiving anticonvulsants, muscle relaxants, opioids, steroids, benzodiazepines in the last week; receiving thioridazine.
Age
From 18 years old
Gender
Both
Phase
3
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
Not 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
Tehran University of Medical Sciences, Keshvarz Blvd
City
Tehran
Postal code
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.TUMS.REC.1395.114
Health conditions studied
1
Description of health condition studied
Fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia
Primary outcomes
1
Description
Severity of pain
Timepoint
Baseline and weeks: 2, 4, 6 and 8 after beginig of the treatment
Method of measurement
Breif Pain Index(BPI)
2
Description
Severity of fatigue
Timepoint
Baseline and weeks: 2, 4, 6 and 8 after beginig of the treatment
Method of measurement
Global Fatigue Index
3
Description
Severity of fibromyalgia symptoms
Timepoint
Baseline and weeks: 2, 4, 6 and 8 after beginig of the treatment
Method of measurement
Fibromyalgia Impact Questionnaire(FIQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: capsule Duloxetine 30 mg paer day in the first week and then 30 mg BID for 7 weeks
Category
Treatment - Drugs
2
Description
Intervention group 2: capsule saffron 15 mg per day in the first week and then 15 mg BID for 7 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Imam-Khomeini Hospital
Full name of responsible person
Prof. Shahin Akhondzadeh
Street address
Imam-Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud Yunesian
Street address
Tehran University of Medical Sciences, Keshvarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Roozbeh Hospital, South Kargar street
City
Tehran
Postal code
Phone
+98 21 5541 2222
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)