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Efficacy of persian carrot (Parsnip) syrup on fatigue in multiple sclrosis patients; a triple blinded randomized controlled trial

Protocol summary

Summary
The main aim of this study is to determine the effects of Parsnip syrup (a product based on Persian carrot and composed from anise, honey, saffron, dianthus, Green cardamom and Nardosthacys Jatamansi) on fatigue of multiple sclerosis (MS) patients. The practical purpose of it is to introduce an effective drug with low side effects for treatment of fatigue based on Iranian traditional medicine. Type of the study is the third phase of triple-blinded randomized clinical trial, one central and controlled with placebo. The study population is selected randomly from the MS patients who referred to traditional medicine clinics of Tehran University of Medical Sciences having fatigue complaint, after filling consent form. The sample size in each group is 48 people. Group A & B Receiving Parsnip syrup or placebo twice a day each time 10 cc respectively. Inclusion criteria:18 - 50 years old, definite MS patients, not been in a new attack during the intervention period or the recent month. Exclusion criteria: Severe depression, pregnancy, history of skin allergy to Apiaceae family, taking drug for depression or fatigue or anticoagulant drugs, starting the disease modifying drugs within the recent 3 months or suffering from diabetes mellitus. Intervention duration is from Khordad 1395 to Khordad 1396 (May 2016- May 2017). Based on valid Persian forms of Fatigue Severity Scale (FSS), Modified Fatigue Impact Scale (MFIS) and Analogue visual scale (VAS) questionnaires fatigue severity will be determined before and after the intervention and possible side effects will be recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016031127013N1
Registration date: 2016-06-12, 1395/03/23
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-06-12, 1395/03/23
Registrant information
Name
Maryam Abasi
Name of organization / entity
Traditional Iranian Medicine,Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6675 4151
Email address
m.abbasi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Traditional Medicine Faculty of Tehran University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of persian carrot (Parsnip) syrup on fatigue in multiple sclrosis patients; a triple blinded randomized controlled trial
Public title
Efficacy of persian carrot in multiple sclrosis patients'fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Definite diagnosis of multiple sclerosis (MS)؛ No evidence or symptom of new attack of MS؛ Age between 18 to 50 years؛ One month after last attack, at least. Exclusion criteria: Severe depression؛ Pregnancy؛ History of skin allergy to Apiaceae family (carrot, anise…)؛ Taking drug for depression or fatigue such as amantadine, pemoline, modafinil, bupropion, fluoxetine… during or until 2 weeks from the entrance to the study. (Washout period = 2 weeks)؛ Starting the disease modifying drugs (such as interferon) within the recent 3 months؛ Using the energy drinks؛ Taking the anticoagulant drugs such as warfarin, heparin, low molecular heparins or aspirin؛ Diabetes mellitus.
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 Science
Street address
Tehran University of Medical Science,Poursina Avenue,Qods street,Enqelab street,Tehran
City
Tehran
Postal code
Approval date
2016-02-22, 1394/12/03
Ethics committee reference number
IR.TUMS.REC.1394.2044

Health conditions studied

1

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

Primary outcomes

1

Description
Fatigue
Timepoint
at the begining of drug usage and after 4 weeks of the drug usage
Method of measurement
MFIS, FSS AND VAS QuestionareS

2

Description
depression severity
Timepoint
at the begining of drug usage
Method of measurement
short form of Beck depression inventory

Secondary outcomes

1

Description
side effects
Timepoint
after 4 weeks of drug usage
Method of measurement
questionare for side effects that developed by the researcher

Intervention groups

1

Description
taking oral Parsnip syrup 10 cc, at morning and evening, for 4 weeks
Category
Treatment - Drugs

2

Description
taking oral placebo syrup 10 cc, at morning and evening, for 4 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Traditional Iranian Medicine Clinic of Tehran University of Medical Sciences
Full name of responsible person
Maryam Abbasi
Street address
Khark Avenue, Enghelab Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Traditional Medicine Faculity of Tehran University of Medical Scienc
Full name of responsible person
Dr Roja Rahimi
Street address
NO 67, Gity َAlley, Vafamanesh Avenue, Heravy Square, Pasdaran
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 Traditional Medicine Faculity of Tehran University of Medical Scienc
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
Traditional Iranian medicine clinic of Tehran University of Medical Sciences
Full name of responsible person
Maryam Abbasi
Position
PHD student
Other areas of specialty/work
Street address
Khark Avenue, Enghelab Street
City
Tehran
Postal code
Phone
+98 21 6675 4151
Fax
Email
abasym56@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Traditional Iranian medicine clinic of Tehran University of Medical Science
Full name of responsible person
Dr Hossein Rezaeizade
Position
Traditional Iranian medicine specialist
Other areas of specialty/work
Street address
Sarparast Avenue, Taleghani Street
City
Tehran
Postal code
Phone
+98 21 8897 6527
Fax
Email
rezaeizadeh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Traditional Iranian medicine clinic of Tehran University of Medical Science
Full name of responsible person
Maryam Abbasi
Position
PHD student
Other areas of specialty/work
Street address
Khark Avenue, Enghelab Street
City
Tehran
Postal code
Phone
+98 21 6675 4151
Fax
+98 21 6675 4173
Email
abasym56@gmail.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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