Efficacy and safety of Iranian traditional medicine product, Jollab-e-monzej, compared with placebo, for the treatment of fatigue and insomnia in multiple sclerosis patients
Efficacy and safety of Iranian traditional medicine product, Jollab-e-monzej; compared with placebo, for the treatment of fatigue and insomnia in multiple sclerosis patients
Design
Eighty participants in phase 3, double-blind parallel group, randomized clinical trial with outcome assessment, based on random sheets of code in sealedenvelope site, were assigned to either the drug or placebo intervention groups.
Settings and conduct
The study runs after approval of the proposal, registration with research center and permission from the Ethics Committee, and registration with the Center Iran's clinical trial.Patients with multiple sclerosis, referred to the neurologist's office, were randomly divided into two intervention groups, based on inclusion and exclusion criteria.FSS, PSQI, BDI and VAS questionnaires are completed for each individual at the bigining and end of one month (completion of treatment) and also two week after that, again.
Participants/Inclusion and exclusion criteria
Inclusion criteria
-Multiple sclerosis (MS) patients, female or male
-Age range 18-55 years
-Patients with relapsing-remitting MS
-MS patients with EDSS of less than or equal to 6
-MS patients are suffering from fatigue and insomnia
-Fatigue score greater than or equal to 36 on the FSS questionnaire
-Inappropriate score at least one of the subscales of the PSQI questionnaire
-Consent to participate in the study
No inclusion criteria
-Pregnancy and lactation
-The comorbidity of severe and chronic disease
-known active infection
-Suffering from psychosis or dementia
-Depression in BDI questionnaire
-Patients with a change in main drug of MS, for the past two months
Intervention groups
In this study, drug group receive, the traditional Iranian product, and placebo group, consume a product; containing a small amount of one component of the drug.
Main outcome variables
Jollab-e-monzej; Fatigue; Insomnia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190623043984N1
Registration date:2020-01-10, 1398/10/20
Registration timing:prospective
Last update:2020-01-10, 1398/10/20
Update count:1
Registration date
2020-01-10, 1398/10/20
Registrant information
Name
Fatemeh Yousefnia babaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
fyousefnia@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of Iranian traditional medicine product, Jollab-e-monzej, compared with placebo, for the treatment of fatigue and insomnia in multiple sclerosis patients
Public title
Effect of "Jollab-e-monzej" for the treatment of fatigue and insomnia in multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
-Multiple sclerosis patients, female or male
-Age range 18-55 years
-Patients with relapsing-remitting MS
-MS patients with EDSS of less than or equal to 6
-MS patients are suffering from fatigue and insomnia
-Fatigue score greater than or equal to 36 on the FSS questionnaire
-Inappropriate score at least one of the subscales of the PSQI questionnaire
-Consent to participate in the study
Exclusion criteria:
-Pregnancy and lactation
-The comorbidity of severe and chronic disease
-known active infection
-Suffering from psychosis or dementia
-Depression in BDI questionnaire
-Patients with a change in main drug of MS for the past two months
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
After calculating the final sample size of the study, Random chains are generated based on simple random series using permuted block at sealedenvelope site for two intervention and comparison groups. Then a matched code will be generated for each sequence, based on random chain, which contains two letters of the alphabet and one number.The anonymous code is pasted on the study drugs (research label) before starting the study and also are stored.During the study, patients are given medication, according to the sequence of patient's entry and randomization sheets (containing only anonymous codes) of the medications stored.Therefore, the research drug distributors and participants in the study are blinded to the assigned group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researcher who performs process, is also clinical caregiver and outcome evaluator that assigns participants based on randomization codes sheets into two groups; intervention medication group and intervention placebo group.During the study, patients are given medication, according to the sequence of patient's entry and randomization sheets (containing only anonymous codes) of the medications stored.Therefore, the research drug distributors and participants in the study are blinded to the assigned group. The pharmacist as well as the data analyzer get inform about group assignment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
----
Secondary trial Id
----
Registration date
1846-07-27, 1225/05/05
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی شهید بهشتی
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak,Shahid Beheshti University of medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-03-17, 1397/12/26
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.1395
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 score on the fatigue severity scale questionnaire
Timepoint
Measurement of fatigue score at baseline and after one month (intervention period) and also two weeks after intervention period
Method of measurement
Fatigue severity scale questionnaire
2
Description
Sleep disorder score on subscales of pittsburgh sleep quality index
Timepoint
Measurement of sleep disorder score at baseline and after one month (intervention period) and also two weeks after
Method of measurement
Pittsburgh sleep quality index questionnaire
Secondary outcomes
1
Description
Fatigue score on the visual analogue score
Timepoint
Measurement of fatigue score at baseline and after one month (intervention period) and also two weeks after intervention period
Method of measurement
Visual analogue scale
Intervention groups
1
Description
Intervention group: Intervention group 1: Jollab-e-monzej syrup, which the participants consume in the morning and evening, 20 to 30 ml, depending on their weight, for one month.
Category
Treatment - Drugs
2
Description
Control group:Intervention group 2: Placebo syrup, which the participants consume in the morning and evening, 20 to 30 ml, depending on their weight, for one month.