Evaluation of clarithromycin on IL-6 serum level in patients with multiple sclerosis: A randomized, double-Blind, crossover, placebo-controlled pilot study
Evaluation of the effect of clarithromycin on improving quality of life and modification of inflammatory factor (IL-6)
Design
A randomized, double-Blind, crossover, placebo-controlled pilot study
Settings and conduct
Patients are randomly assigned to receive either clarithromycin or placebo tablet twice daily for 14 days. Subsequently, after a 1-month washout, they were crossed over to the other group during the course of the trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 20 t 60 years
Confirmed diagnosis of primary progressive MS
No medical history of allergy to clarithromycin
Exclusion criteria:
Pregnancy and lactation
Serious underlying medical conditions (e.g malignancy, renal and hepatic failure)
Known hypersensitivity to clarithromycin and excipients
Significant signs of depression
Intervention groups
MS patients were randomly assigned to receive either clarithromycin (500mg) or placebo tablets twice daily for 14 days. Subsequently, after a 1-month washout, they were crossed over to the other group during the course of the trial.
Main outcome variables
Evaluation of clarithromycin on interleukin six serum level and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100119003106N40
Registration date:2020-07-10, 1399/04/20
Registration timing:registered_while_recruiting
Last update:2020-07-10, 1399/04/20
Update count:0
Registration date
2020-07-10, 1399/04/20
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clarithromycin on IL-6 serum level in patients with multiple sclerosis: A randomized, double-Blind, crossover, placebo-controlled pilot study
Public title
Evaluation of clarithromycin on IL-6 serum level in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 t 60 years
Confirmed diagnosis of primary progressive progressive MS
No medical history of allergy to clarithromycin
Exclusion criteria:
Pregnancy and lactation
Serious underlying medical conditions (e.g malignancy, renal and hepatic failure)
Known hypersensitivity to clarithromycin and excipients
Significant signs of depression
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
28 envelopes are prepared with 14 active and 14 placebo cards and shuffled. Patients are allocated the next study number (1–28) in sequence after opening the sealed envelopes to either drug or placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, physicians, researcher and data collector (student) don’t know about who was receving the actual drug and who receving a placebo.
The informed consent was obtained from patients and they were informed that they could leave the trial at any time.
The coding of the medicine boxes was done by a third party who was not involved in the study and at the end of the study, decryption took place.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Tehran Medical Sciences
Street address
No 99, Yakhchal street, Gholhak, Dr Shariati street
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2019-11-20, 1398/08/29
Ethics committee reference number
IR.IAU.TMU.REC.1398.135
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Interleukin 6
Timepoint
Before intervention, week 2, 6 and 8 after intervention
Method of measurement
ELISA Kit
2
Description
Quality of life
Timepoint
Before intervention, week 2, 6 and 8 after intervention
Method of measurement
The quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
MS patients were randomly assigned to receive either clarithromycin (500mg) or placebo tablets twice daily for 14 days. Subsequently, after a 1-month washout, they were crossed over to the other group during the course of the trial.
No. 99, Yakhchal street, Dr. Shariati Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
hashemian.f@iaups.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
10
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Ghazal Amiri
Position
Pharm. D., candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yasaman Alley, Yakhchal St, Shariati Av
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
ghazalamiri1995@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Farshad Hashemian
Position
Pharm.D., BCPS, Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yasaman Alley, Yakhchal St, Shariati Av
City
Tehran
Province
Tehran
Postal code
193956466
Phone
+98 21 2264 0599
Email
hashemian.f@iaups.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghazal Amiri
Position
Pharm. D. candidate
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yasaman Alley, Yakhchal St, Shariati Av
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
ghazalamiri1995@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All the data potentially can be shared after being unidentifiable.
When the data will become available and for how long
Just after the article's publication.
To whom data/document is available
For all investigators.
Under which criteria data/document could be used
No more information.
From where data/document is obtainable
Applicants can refer to the Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Dr.Hashemian or contact the researcher by sending email to ghazalamiri1995@gmail.com or calling 09120680122.
What processes are involved for a request to access data/document
Applicants can apply for research information by visiting the department or by contacting the e-mail address and telephone number as well as providing information on academic studies and the purpose of requesting the information. Applicants must commit themselves to mention the source. If the request is sent six months after the publication of the research information, the researcher will send the data to the requesting party by email within a week.