The effect of oral cocoa powder on symptoms of fatigue among patients with multiple sclerosis (MS) compared to placebo
Design
A clinical trial without a control group, triple blinded, randomized
Settings and conduct
The study is a randomized, tripple-blind clinical trial for 2 months in MS patients referred to Kashani hospital neurology. The drug will be taken 25 g daily in the morning and afternoon doses. Patients will take the drug regularly for eight weeks. If you forget a dose of the drug, you can take the drug for an hour later, and if you forget the drug for more than one hour, reapply for the next hour. If the drug is not taken for two consecutive days or forgotten for a total of 10 doses, these patients will be excluded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to participate in the study; MS with Relapsing remitting form; Less than 10 years have passed since their diagnosis; Age between 20 and 50 years; Have a Fatigue severity scale above 4; The EDSS score is below 6; Have a recent anemia and hypothyroid rejection test in one month; Exclusion criteria: Have recurrent in the past 3 months; The disease involves the CNS except migraine; They have acute febrile illness; Have systemic autoimmune disease; Based on Beck Depression Inventory moderate or severe (Questionnaire score above 20); Currently taking neurotoxic drugs including: antipsychotic agents, monoamine oxidase inhibitors, benzodiazepines, tricyclic antidepressant drugs, anticonvulsants, beta blockers and barbiturates
Intervention groups
We have two intervention groups. The first group received the drug in the form of 12.5 grams of cocoa powder, and the second group received a placebo containing 2.5 grams of cocoa powder.
Main outcome variables
Fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N34
Registration date:2020-03-28, 1399/01/09
Registration timing:prospective
Last update:2020-03-28, 1399/01/09
Update count:0
Registration date
2020-03-28, 1399/01/09
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-30, 1399/01/11
Expected recruitment end date
2020-06-29, 1399/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of cocoa powder on fatigue severity in patients with multiple sclerosis(MS) in comparison with placebo effect
Public title
The effect of cocoa powder on fatigue in multiple sclerosis patients
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study
MS with Relapsing remitting form
Less than 10 years have passed since their diagnosis
Age between 20 and 50 years
Have a Fatigue severity scale above 4.
The EDSS score is below 6
Have a recent anemia and hypothyroid rejection test in one month
Exclusion criteria:
Have recurrent in the past 3 months
The disease involves the CNS except migraine
They have acute febrile illness
Have systemic autoimmune disease
Based on Beck Depression Inventory moderate or severe (Questionnaire score above 20)
Currently taking neurotoxic drugs including: antipsychotic agents, monoamine oxidase inhibitors, benzodiazepines, tricyclic antidepressant drugs, anticonvulsants, beta blockers and barbiturates
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients in the study were randomly assigned to either A or B groups using computer software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
At first the drug powder and placebo optionally into groups A and B are packed without the knowledge of a physician, patient, or analyzer (note that only the first person knows that package A is the drug or placebo). The software is divided into recipient groups A and recipient B, which will be written in the form A or B.After completing the design and final analysis, the packaging person announces that A B Which powder (drug or placebo) each had. According to this physician, the patient and the analyzer were unaware of the groups until after the data was analyzed
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2019-11-26, 1398/09/05
Ethics committee reference number
IR.MUI.MED.REC.1398.445
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
Before and after the study
Method of measurement
With MFIS and FSS questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The drug will be administered in the form of 12.5 grams of cocoa powder after dissolving in a glass of water half an hour before or one hour after meals.
Category
Treatment - Drugs
2
Description
Control group: receive placebo. Each placebo pack contains 2.5 grams of cocoa powder (much less than the effective and therapeutic dose of cocoa) that can be used in 200 cc of boiling water or milk.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Iman Adibi
Street address
Kashani Street, Isfahan Province, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 7539
Email
i.adibi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Iman Adibi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Kashani Hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 7539
Email
i.adibi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Iman Adibi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Kashani Hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 7539
Email
i.adibi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Iman Adibi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Kashani Hospital
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 7539
Email
i.adibi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available