This randomized double blind clinical study is designed to evaluate the antidepressant, antifatigue and hypnotic effects of Persian herbal medicine, in patients with MS. There are three groups including 40 subjects with depression, fatigue and sleep disorder symptoms in each group. Depression, fatigue and sleep disorder will be evaluated by means of questionnaires [BDI, (FSS and MFIS) and (ISI nad PSQI) respectively]. the main inclusion criteria are definite diagnosis of MS; symptoms of depression, fatigue and sleep disorder and not using of antioxidant supplements. The patients will be treated for 4 weeks with either the herbal extract or the placebo. The herbal extract group will receive 10 milliliter of the herbal extract two times a day for 1 month. Each 10 milliliter of the herbal extract contained 15 mg saffron, 60 mg vitis vinifera extract, 200 mg cinnamon and 500 mg HP. At the end of intervention, the effects of herbal extract on depression, fatigue and sleep disorder will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012916369N3
Registration date:2017-10-21, 1396/07/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-21, 1396/07/29
Registrant information
Name
Marziyeh Sadat Tonkaboni
Name of organization / entity
Tehran University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 6111
Email address
rezaeizadeh@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz university of medical sciences
Expected recruitment start date
2015-12-31, 1394/10/10
Expected recruitment end date
2016-06-30, 1395/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Antidepressant, anti-fatigue and hypnotic Effects of a Persian Herbal Extract on Multiple Sclerosis Patients: A double blind randomized clinical trial
Public title
Effects of a Persian Herbal Extract in treatment of Multiple Sclerosis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: definite diagnosis of MS; age range of 18 to 50 years old; Expanded Disability Status Score (EDSS) of less than or equal to 6; no disease attack during the previous month; no history of other autoimmune diseases; disease stable status during last three months; presence of depression, fatigue and sleep disorder symptoms; not using other antioxidant or herbal supplement during study.
Exclusion criteria: evidence of dementia or psychosis; cardiovascular disease; diabetes; severe depression; clinically significant major infections; pregnancy and breastfeeding status; disease attack during the study; not willingness to continue the study.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
using the method of random numbers
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, PO Box: 5165665931, Iran
City
Tabriz
Postal code
5165665931
Approval date
2015-03-18, 1393/12/27
Ethics committee reference number
5/84/1955
Health conditions studied
1
Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
depression
Timepoint
baseline and endpoint
Method of measurement
Beck depression inventory
Secondary outcomes
1
Description
fatigue and sleep disorders
Timepoint
baseline and endpoint
Method of measurement
fatigue severity scale (FSS), modified fatigue impact scale (MFIS), insomnia severity scale (ISI) and Pittsburgh sleep quality index (PSQI).
Intervention groups
1
Description
Intervention group: The patients in the intervention group will be treated with 10 milliliters of the herbal extract twice a day for 4 weeks. Each 10-milliliter dose of the herbal extract contains 15 mg saffron, 60 mg vitis vinifera, 200 mg cinnamon and 500 mg hypericum performatum.
Category
Treatment - Drugs
2
Description
control group: patients will receive placebo twice a day for 4 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Dr. Maryam Adalat
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Rashidi
Street address
No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
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 Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Maryam adalat
Position
Phd
Other areas of specialty/work
Street address
Faculty of Traditional Medicine
City
Tabriz
Postal code
-
Phone
+98 41 3335 5921
Fax
-
Email
mar.adalat@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Maryam adalat
Position
Phd
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Faculty of Traditional Medicine
City
Tabriz
Postal code
Phone
+98 21 3335 5921
Fax
-
Email
mar.adalat@gmail.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
maryam adalat
Position
Phd
Other areas of specialty/work
Street address
-
City
Tabriz
Postal code
-
Phone
-
Fax
-
Email
mar.adalat@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)