Protocol summary

Summary
This research aims to achieve an effective inexpensive traditional medicine treatment for MS-related fatigue by study on the effect of a traditional medicine-based product (Majoon Baadam) to reduce MS-related fatigue. The key inclusion criteria are: MS diagnosis based on McDonald criteria by a neurologist adviser, MS-related fatigue lasting at least one month, consciously accepting subscription form, no simultaneous anti-fatigue medical treatment, Expanded Disability Status Scale (EDSS) equal or less than 6, MFIS more than 45, no crisis of disease over the previous 60 days. Key exclusion criteria are: relapse of disease over the study period, uncontrolled diabetes, blood hypertension, pregnant or lactating mothers, severe infection and severe mental disorders. Seventy MS patients after fulfillment of inclusion and exclusion criteria, randomly use either product or placebo with certain daily dose for four weeks (35 patients in each group). Product and placebo are given by director of pharmacy to the patients in similar coded packs and coded forms will be processed by researcher, so in this way blinding of patients and researcher is done(double-blind). On this basis all patients will be checked before and 4 weeks after intervention by primary outcome measures including Modified Fatigue Impact Scale (MFIS), Visual Analog Scale (VAS) and secondary outcome measures including PITTSBURGH SLEEP QUALITY INDEX (PSQI), Rome III criteria for constipation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014050317545N1
Registration date: 2014-05-24, 1393/03/03
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-05-24, 1393/03/03
Registrant information
Name
Mehdi Sardari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5560 1274
Email address
sardari_m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Faculty of Traditional Iranian Medicine of Tehran University of Medical Sciences
Expected recruitment start date
2014-05-25, 1393/03/04
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of the Effect of Traditional Medicine Product (majoon baadam) on Multiple Sclerosis-related Fatigue level
Public title
Effect of Traditional Medicine Product on MS-related Fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: MS diagnosis, either relapsing remitting (RR) secondary progressive (SP) or primary progressive, based on specified criteria of modern medicine by MC.Donald criterion approved with neurologist; MS-related fatigue lasting at least one month and there should be indication of anti fatigue treatment; consciously accepting subscription form/ letter of satisfaction; patient shouldn't be under simultaneous anti-fatigue medical treatment; not using any other natural or herbal treatment by the patient during the study; lack of any record of sensitivity to drug ingredients; EDSS equal or less than 6; MFIS more than 45; no crisis of disease over the previous 60 days and Exclusion criteria: relapse of disease over the study period; uncontrolled diabetes; blood hypertension; pregnant or lactating mothers; severe infection; severe mental disorders
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Ethics Committee of Tehran University of Medical Sciences
Street address
501, 5th Floor, Central Building of Tums, Keshavarz and Qods Junction, Tehran, Iran
City
Tehran
Postal code
Approval date
2013-10-09, 1392/07/17
Ethics committee reference number
130/1485/د/92

Health conditions studied

1

Description of health condition studied
Neurasthenia, Malaise and fatigue
ICD-10 code
F48, R53
ICD-10 code description
Neurasthenia, Malaise and fatigue

2

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Modified Fatigue Impact Scale (MFIS) Standard Questionnaire
Timepoint
Before intervention and after four weeks
Method of measurement
Filling out Modified Fatigue Impact Scale (MFIS) Standard Questionnaire by the patient

2

Description
Visual Analog Scale (VAS) for Fatigue
Timepoint
Before intervention and after four weeks
Method of measurement
Filling out Visual Analog Scale (VAS) by the patient

Secondary outcomes

1

Description
Sleep Quality of patients contributed in the study
Timepoint
Before intervention and after four weeks
Method of measurement
Filling out Pittsburgh Sleep Quality Index (PSQI) by the patient

2

Description
Constipation in patient
Timepoint
Before intervention and after four weeks
Method of measurement
Filling out Rome III Criteria for constipation module by the patient

Intervention groups

1

Description
In intervention group: Using product (majoone badaam) with 15 grams daily dose, orally, divided into three times: fasting, one hour before lunch, one and half to two hrs after lunch over four weeks.
Category
Treatment - Drugs

2

Description
In control group: Using placebo with 15 grams daily dose, orally, divided into three times: fasting, one hour before lunch, one and half to two hrs after lunch over four weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Traditional Iranian Medicine of TUMS
Full name of responsible person
Mehdi Sardari
Street address
Corner of Behesht St, Hasanabad Square, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Faculty of Traditional Iranian Medicine of Tehran University of Medi
Full name of responsible person
Dr.Mohammad bagher Minaee
Street address
Corner of Behesht St, Hasan Abad Square
City
Tehran
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 Faculty of Traditional Iranian Medicine of Tehran University of Medi
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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Bagher Minae
Position
Deputy director of research of Faculty of Traditional Iranian Medicine of TUMS
Other areas of specialty/work
Street address
Corner of Behesht St, Hasanabad Square
City
Tehran
Postal code
Phone
+98 21 5560 1274
Fax
Email
minaezb@sina.tums.ac.ir ; dr_tours@yahoo.com
Web page address
http://tim.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Traditional Iranian Medicine of Tehran University of Medical Sciences
Full name of responsible person
Mehdi Sardari
Position
Ph.D Student of Traditional Iranian Medicine
Other areas of specialty/work
Street address
Corner of Behesht St, Hasan Abad Square
City
Tehran
Postal code
Phone
+98 21 5560 1274
Fax
Email
sardari_m@razi.tums.ac.ir ; dr_tours@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Traditional Iranian Medicine of Tehran University of Medical Sciences
Full name of responsible person
Mehdi Sardari
Position
Ph.D Student of Traditional Iranian Medicine
Other areas of specialty/work
Street address
Corner of Behesht St, Hasanabad Square
City
Tehran
Postal code
Phone
+98 21 5560 1274
Fax
Email
sardari_m@razi.tums.ac.ir ; dr_tours@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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