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Evaluation the effects of Saffron pill in comparison to placebo on rheumatoid arthritis disease activity level

Protocol summary

Summary
(1) Aim of study: Evaluation the effects of Saffron extract on rheumatoid arthritis disease activity in newly diagnosed patients. (2) Major inclusion and exclusion criteria: All the patients with completed informed consent form and with diagnosis of rheumatoid arthritis disease who didn't receive any treatment and with over 18 years old will be included in the study. (3) Study population and sample size: 60 patients with newly diagnosed Rheumatoid Arthritis. (4) Study Intervention: In intervention group, patients will receive Saffron pill containing 100 mg Saffron extract once a day for 4 months in addition to standard treatment including: 5 mg Prednisolone daily, 7.5 mg oral Methotrexate weekly, 5 mg Folic acid weekly, 400 IU Vitamin D daily, 800 mg Calcium daily, 70 mg Alendronate weekly. In the control group, patients will receive Placebo pill containing "Sunset" paint once a day for 4 months in addition to standard treatment the same as intervention group. (5) Primary outcomes: Disease activity level, in the beginning of study and 1, 2.5, and 4 months after study initiation, will be evaluated using determined formula for DAS28-ESR, which is on the basis of physical examination, ESR level, and patient self assessment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014071218453N1
Registration date: 2015-05-15, 1394/02/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-05-15, 1394/02/25
Registrant information
Name
Hossein Heidari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1841 0136
Email address
heidarih861@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mashhad University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of Saffron pill in comparison to placebo on rheumatoid arthritis disease activity level
Public title
Effect of Saffron on Rheumatoid Arthritis treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: To have four criteria of ACR-1987 for Rheumatoid Arthritis; New patients who haven’t received any standard treatment up to the time of the study; Patients over 18 years old. Exclusion criteria: Pregnancy; Breast-feeding; Diagnosed sensitivity to saffron; Diagnosed hepatic and renal diseases; Other comorbid rheumatologic diseases; Malignancies and/or active infections; Diagnosed psychological diseases.
Age
From 18 years old to 100 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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 Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Daneshgah street, Mashhad, Khorasan-Razavi, Iran
City
Mashhad
Postal code
Approval date
2014-05-24, 1393/03/03
Ethics committee reference number
922383

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified

Primary outcomes

1

Description
Disease activity level according to DAS28-ESR score
Timepoint
Beginning of study - 1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study
Method of measurement
Using determined formula for DAS28-ESR which is according to physical examinations, ESR level, and patient self-assessment

Secondary outcomes

1

Description
HAQ-DI
Timepoint
Beginning of study - 1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study
Method of measurement
According to HAQ-DI questionnaire which is translated to Persian and its validation has been assessed

2

Description
EULAR response
Timepoint
1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study
Method of measurement
According to EULAR criteria table on the basis of DAS28-ESR score

3

Description
Saffron pill adverse effects
Timepoint
1 month after beginning of study - 2.5 months after beginning of study - 4 months after beginning of study
Method of measurement
According to check list containing known adverse effects of Saffron

Intervention groups

1

Description
Intervention group: Saffron pill containing 100 mg Saffron extract once a day for 4 months in addition to standard treatment including: - 5 mg Prednisolone daily - 7.5 mg oral Methotrexate weekly - 5 mg Folic acid weekly - 400 IU Vitamin D daily - 800 mg Calcium daily - 70 mg Alendronate weekly
Category
Treatment - Drugs

2

Description
Control group: Placebo pill containing "Sunset" paint once a day for 4 months in addition to standard treatment including: - 5 mg Prednisolone daily - 7.5 mg oral Methotrexate weekly - 5 mg Folic acid weekly - 400 IU Vitamin D daily - 800 mg Calcium daily - 70 mg Alendronate weekly
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rheumatic Diseases Research Center (RDRC), Ghaem Educational, Research and Treatment Center, Mashhad
Full name of responsible person
Street address
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Daneshgah street, Mashhad, Khorasan-Razavi, Iran
City
Mashhad
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 of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Heidari
Position
Medical student
Other areas of specialty/work
Street address
Rheumatology Diseases Research Center, Ghaem Hospital, Ahmad-abad street, Mashhad, Khorasan-Razavi, Iran
City
Mashhad
Postal code
Phone
+98 51 3801 2753
Fax
Email
heidarih861@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Maryam Sahebari
Position
Assistant Professor of Rheumatology
Other areas of specialty/work
Street address
Rheumatology Diseases Research Center, Ghaem Hospital, Ahmad-abad street, Mashhad, Khorasan-Razavi, Iran
City
Mashhad
Postal code
Phone
+98 51 3801 2753
Fax
Email
sahebariM@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
Hossein Heidari
Position
Medical student
Other areas of specialty/work
Street address
Mashhad University of Medical Sciences, Daneshgah street, Mashhad, Khorasan-Razavi, Iran
City
Mashhad
Postal code
Phone
+98 51 3801 2753
Fax
Email
Heidarih861@mums.ac.ir Hossein.heidari1@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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