This double-blind randomized controlled trial will be conducted to evaluate the effect of grape seed on fatigue in MS patients. This double-blind randomized controlled trial will be conducted to evaluate the effect of grape seed on fatigue in MS patients. From patients referred to Ahvaz Golestan Hospital from March 2017 to March 2018, 66 ones with M.S. fatigue between the ages of 15 and 65 are included in the present study. They will be divided into two treatment and control groups. Patients will be excluded from the study if they are pregnant, affected by drug side effects, etc. In addition to a primary drug (interferon), both groups will receive grape seed capsules (300 mg of extract) or placebo capsules twice a day for one month. The Modified Fatigue Impact Scale (MFIS) and Multiple Sclerosis Quality of Life-54 (MSQl-54) questionnaires will be used to evaluate patients. The questionnaires will be completed by a specialist at the beginning and 1 month after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201708218013N1
Registration date:2017-11-07, 1396/08/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-07, 1396/08/16
Registrant information
Name
Amir Siahpoosh
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3334 2197
Email address
siahpoosh-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitis vinifera seed extract on fatigue of MS patients
Public title
Investigating of red grape seeds on MS fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: MS patients have fatigue; No other neurological disease; No Diseases like diabetes and autoimmune diseases; No new attack in the last month
Exclusion criteria: Emergence of drug side effects; New disease attack; Do not take medicine for one week; Pregnancy
Age
From 15 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz, golestan road
City
Ahvaz
Postal code
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.ajums.REC.1396.326
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
2
Description of health condition studied
Neurasthenia
ICD-10 code
F48.0
ICD-10 code description
Neurasthenia
Primary outcomes
1
Description
MFIS
Timepoint
Start intervention and a month later
Method of measurement
MFIS questionnaire
2
Description
MSQL-54
Timepoint
Start intervention and a month later
Method of measurement
MSQL-54 questionnaire
Secondary outcomes
1
Description
side effects
Timepoint
One month after the intervention began
Method of measurement
observation
Intervention groups
1
Description
Control group: Interferon (main treatment) with placebo capsules (twice daily) for one month
Category
Treatment - Drugs
2
Description
Treatment group: Interferon (main treatment) with grape seed capsules (twice daily) for one month, each capsule contained 300 mg extract
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital in Ahvaz
Full name of responsible person
Amir Siahpoosh
Street address
Medicinal Plants Research Center and Deparment of Pharmacognosy, Faculty of Pharmacy, Ahvaz Jundishapur University of medical Sciences, Ahvaz, Iran
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences, medicinal plants research center
Full name of responsible person
Dr Behzad Sharif Makhmalzadeh
Street address
Ahvazm golestan road
City
ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences, medicinal plants research 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Amir siahpoosh
Position
Ph.D pharmacognosy
Other areas of specialty/work
Street address
Ahvaz, golestan road
City
Aَhvaz
Postal code
Phone
+61 33375356
Fax
Email
amirsiahpoosh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Amir Siahpoosh
Position
Ph.D Pharmacognosy
Other areas of specialty/work
Street address
Ahvaz, Golestan Road
City
Ahvaz
Postal code
Phone
+61 33375356
Fax
Email
amirsiahpoosh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medicinal Plants Research Center and Deparment of Pharmacognosy, Faculty of Pharmacy, Ahvaz Jundisha
Full name of responsible person
Amirsiahpoosh
Position
Ph.D pharmacognosy
Other areas of specialty/work
Street address
Ahvaz, Golestan road
City
Ahvaz
Postal code
Phone
+98 916 612 1382
Fax
Email
Amirsiahpoosh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)