This is a phase II clinical trial for safety and efficacy of herbal drug(BMP) in Multiple Sclerosi . In this study ten patients with the diagnosis of Multiple sclrosis who had not respond to standard treatment will be recruited. Patients will take oral herbal component as capsules. Each cap containes 500mg active ingredient from Xanthins and the source herb is a kind of pepper and ; patients take 4 cap a day for six months and will follow for six months afterend of treatment . The treatment with the drug will add to standard treatment. Primary outcomes are changes in MRI and secondary outcomes are EDSS and MSIS quality of life questionaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803241696N2
Registration date:2009-09-26, 1388/07/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-09-26, 1388/07/04
Registrant information
Name
Shahriar Nafissi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2224
Email address
nafisi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran Rheumatism Center
Expected recruitment start date
2009-06-14, 1388/03/24
Expected recruitment end date
2009-09-14, 1388/06/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial phase II of oral hebal compoenent (BMP) in patient with multiple sclerosis
Public title
Clinical trial phase II of oral hebal compoenent (BMP) in patient with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 50
Multiple sclerosis diagnosis by Mac Donald criteria
EDSS more than six
Signing informed consent
Exclusion criteria:
Sever hepatic/ Renal or cardiac diease
Sever psychological disorders
Adminstration of IVIG, Mitoxantrone, Plasmapheresis or immunosupressive drug since three months before
Pegnancy or intention to pregnancy
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethice Committee of Endocrinology and Metabolism Research Center
Street address
Fifth Floor, Shariati Hospital, North Kargar St., Tehran, Iran
City
Tehran
Postal code
14114
Approval date
2009-04-21, 1388/02/01
Ethics committee reference number
E-0034
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35, G36,
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Changes in MRI (Magnetic Resonance Imaging)
Timepoint
start of treatment, 6th and 12th month
Method of measurement
Magnetic Resonance Imaging
Secondary outcomes
1
Description
EDSS
Timepoint
Start of Treatment, 1st, 2nd, 3rd, 4th, 5th, 6th, 8th, 10th, and 12th month
Method of measurement
Asking from patients
2
Description
MSIS quality of life questionnaire
Timepoint
Start of Treatment, 1st, 2nd, 3rd, 4th, 5th, 6th, 8th, 10th, and 12th month
Method of measurement
Completing the questionnaire
Intervention groups
1
Description
BMP oral capsules, each containes 500 mg active ingredient
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Rheumatism Center
Full name of responsible person
Dr. Shahryar Nafisi
Street address
Shariaty Hospital, North Kargar st., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran Rheumatism Center
Full name of responsible person
Dr Shahriar Nafisi
Street address
No.9, khosravi Alley, North Kargar st., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran Rheumatism Center
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
Shariati hospital, Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Dr. Shahryar Nafisi
Position
Associate professor
Other areas of specialty/work
Street address
Shariati hospital, North kargar st., Tehran, Iran
City
Tehran
Postal code
14114
Phone
Fax
Email
nafisi@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shariati hospital, Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Dr. Shahryar Nafisi
Position
Associate Professor
Other areas of specialty/work
Street address
Shariati hospital, North kargar st., Tehran, Iran
City
Tehran
Postal code
14114
Phone
Fax
Email
nafisi@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shariati hospital,Tehran University of Medical Sciences, Tehran, Iran
Full name of responsible person
Dr. Shahryar Nafisi
Position
Associate professor
Other areas of specialty/work
Street address
Shariati hospital, North kargar st., Tehran, Iran
City
Tehran
Postal code
14114
Phone
Fax
Email
nafisi@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)