Evaluation of clinical symptoms and serum level of inflammatory cytokines in patients with HAM/TSP after treatment with gluronic acid compared to control group
Design
A randomized, double-blinded, controlled clinical trial with a parallel group design of 40 patients
Settings and conduct
This study is conducted in the Department of Neurology and Clinic of Ghaem Hospital, Mashhad University of Medical Sciences. Patients and data analyser are blinded to the assigned groups.
Participants/Inclusion and exclusion criteria
Patients diagnosed with spastic paraparesis due to HTLV-1 infection will be included in the study. Any accompanying illness and the passing of more than 15 years from the onset of symptoms are the exclusion criteria.
Intervention groups
daily administration of two capsules of gluronic acid for 12 weeks
Main outcome variables
The measures of MRC (muscle strength); Ashworth (spasticity); OMDS (motor disability); UDS (urinary tract disorder); Serum levels of IL-1, IL-6, IL-8 and TNF-a; Proviral load levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180618040127N1
Registration date:2018-08-22, 1397/05/31
Registration timing:prospective
Last update:2018-08-22, 1397/05/31
Update count:0
Registration date
2018-08-22, 1397/05/31
Registrant information
Name
Zohreh Vahidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3842 9828
Email address
vahidizh3@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-02, 1397/07/10
Expected recruitment end date
2019-01-30, 1397/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of Gluronic acid in HTLV-1 patients and its effect on viral and inflammatory factors
Public title
Evaluation of the effects of Gluronic acid in HTLV-1 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
HTLV-1 positive serology
Symptoms of spastic paraparesis
Presence of anti-HTLV-1 antibody in the cerebrospinal fluid
MDG less than 9
Passing less than 15 years from incidence of disease symptoms
Patient informed consent to participate in the study
Exclusion criteria:
Other causes of spastic paraparesis
receive other drugs that affect the immune system
Existence of other diseases other than HAM / TSP
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization on the individual level will be done using the online tools for random number generation. Then, the sequence will be placed in dark envelopes based on the order of appearance. The researcher chooses the first envelope for each new patient without disturbing the arrangement of the envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are blinded by placebo. The data analyzer is not aware of the study groups.
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
Opposite Daneshgah 18, Daneshgah Avenue, Central bulding of Mashhad University of Medical Sciences (Ghoreishi)
City
Mashhad
Province
Razavi Khorasan
Postal code
91357-345
Approval date
2018-08-11, 1397/05/20
Ethics committee reference number
IR.MUMS.REC.1397.140
2
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Opposite Daneshgah 18, Daneshgah Avenue, Central bulding of Mashhad University of Medical Sciences (Ghoreishi)
City
mashhad
Province
Razavi Khorasan
Postal code
91357-345
Approval date
2018-08-11, 1397/05/20
Ethics committee reference number
IR.MUMS.REC.1397.140
Health conditions studied
1
Description of health condition studied
patients with HTLV-1 associated myelopathy
ICD-10 code
B97.33
ICD-10 code description
Human T-cell lymphotrophic virus, type I [HTLV-I] as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Medical Research Council (MRC) Scale for Muscle Strength
Timepoint
At the begging of study and 12 weeks later
Method of measurement
physical examination
2
Description
spastisite score with Ashworth scale
Timepoint
At the begging of study and 12 weeks later
Method of measurement
physical examination
3
Description
Motor Disability score with Osame Motor Disability Score
Timepoint
At the begging of study and 12 weeks later
Method of measurement
physical examination
4
Description
urinary disturbance score
Timepoint
At the begging of study and 12 weeks later
Method of measurement
physical examination and history
5
Description
serum level of inflammatory cytokines (IL-1, IL-6, IL-8 and TNF-a), Proviral load levels
Timepoint
At the begging of study and 12 weeks later
Method of measurement
serum level evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: daily usage of two capsules of 25 mg/kg of gluronic acid
Category
Treatment - Drugs
2
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem Hospital
Full name of responsible person
Dr. Fariba Zemorshidi
Street address
Ahmad abad Street, before Shariati Square. Qaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
Zemorshidif@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Oposite Daneshgah 18 Street, Daneshgah Street, Central Bulding of Mashhad University of Medical Sciences (Ghoreishi)
City
Mashhad
Province
Razavi Khorasan
Postal code
91357-345
Phone
+98 51 3841 2081
Email
tafaghodim@mums.ac.ir
Grant name
Research grant of Mashhad University of Medical Sciences
Grant code / Reference number
961086
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
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Fariba Zemorshidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Before Shariati Square, Ahmadabad Street, Qaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
zemorshidif@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Reza Boostani
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Before Shariati Square, Ahmadabad Street, Qaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
Boostanir@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Fariba Zemorshidi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Before Shariati Square, Ahmadabad Street, Qaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Email
zemorshidif@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
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
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
No - There is not a plan to make this available
Title and more details about the data/document
Findings of the study on the therapeutic effect of gluoronic acid in HTLV-1 patients and its effect on viral and inflammatory factors
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
contact with the principal investigator
What processes are involved for a request to access data/document
Requesting from the principal investigator and approval of the university vice chancellor