The effect of centella asiatica L. on cognitive disorders in patients with multiple sclerosis by evaluating the changes in the BICAMS (brief international cognitive assessment for MS) test in patients referred to the MS clinic of Shafa-Kerman Hospital.
Design
This double-blind randomized clinical trial, investigated the effectiveness of Centella asiatica on cognitive disorders of patients with MS. Dividing the patients into two equal groups, intervention and control, was done using the quadruple random block method.
Settings and conduct
This research was conducted in the MS clinic of Shafa-Kerman Hospital on at least 96 patients with MS with cognitive impairment. After packaging, the drug and placebo were coded as A and B by the pharmacist. These codes were attached with a label on the drug and placebo package, and only the pharmacist and the biostatistician knew how to assign these codes to the drug and placebo. Then they were provided to the researcher. Neither the researcher nor the patient knew how to assign the codes to the drug or placebo. Finally, the codes and data are given to the statistician and the analysis is done.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
-MS patients with complaints of cognitive impairment referred to the MS clinic and cognitive impairment was proven based on the BICAMS test.
Exclusion criteria:
-suffering from psychiatric diseases such as severe depression and schizophrenia, etc.
-pregnancy
Intervention groups
The drug group received 500 mg capsules containing centella asiatica plant powder and the placebo group received 500 mg capsules containing starch.
Main outcome variables
severity of cognitive impairment; Quality of Life
General information
Reason for update
Acronym
MS
IRCT registration information
IRCT registration number:IRCT20161108030776N5
Registration date:2024-06-15, 1403/03/26
Registration timing:retrospective
Last update:2024-06-15, 1403/03/26
Update count:0
Registration date
2024-06-15, 1403/03/26
Registrant information
Name
Mohadese Kamali
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 2827
Email address
mohadesekamali0912@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2022-12-05, 1401/09/14
Actual recruitment start date
2022-08-23, 1401/06/01
Actual recruitment end date
2023-03-30, 1402/01/10
Trial completion date
2023-05-31, 1402/03/10
Scientific title
The effect of Centella asiatica L. on cognitive impairments in patients with multiple sclerosis (MS)
Public title
The effect of Centella asiatica L. on cognitive disorders in MS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Multiple sclerosis patients with complaints of cognitive impairment referred to the MS clinic and had proven cognitive impairment based on the BICAMS (brief international cognitive assessment for MS) test.
Exclusion criteria:
Suffering from psychiatric diseases such as severe depression, schizophrenia, etc.
pregnancy
breastfeeding
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
96
Actual sample size reached:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Dividing the patients into two equal intervention and control groups was done using the quadruple random block method. The codes of the patients were provided to the biostatistics specialist and were not opened until the end of the intervention period of the last patient and the analysis.
Blinding (investigator's opinion)
Double blinded
Blinding description
After packaging, the drug and placebo were coded as A and B by the pharmacist. These codes were attached with a label on the drug and placebo package, and only the pharmacist and the biostatistician knew how to assign these codes to the drug and placebo. Then they were provided to the researcher. Neither the researcher nor the patient knew how to assign the codes to the drug or placebo. Finally, the codes and data are given to the statistician and the analysis is done.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-04-16, 1401/01/27
Ethics committee reference number
IR.KMU.REC.1401.048
Health conditions studied
1
Description of health condition studied
Multiple sclerosis (MS)
ICD-10 code
G35-G37
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
severity of cognitive impairment
Timepoint
Investigation of cognitive impairment at the beginning of the study (before the start of the intervention) and two months after the start of the intervention with the Centella asiatica
Method of measurement
BICAMS questionnaire
2
Description
Quality of Life
Timepoint
At the beginning of the study (before the start of the intervention) and two months after the start of Centella Asiatica
Method of measurement
MSQOL54 questionnaire
Secondary outcomes
1
Description
Possible side effects
Timepoint
At the end of the study
Method of measurement
Registration by the patient and questions from the patient
Intervention groups
1
Description
Intervention group: Every 12 hours after meals, they received a capsule containing Centella asiatica plant powder for two months.
Category
Treatment - Drugs
2
Description
Control group: Every 12 hours after meals, they received a capsule containing starch, which is exactly the same as the drug group, for two months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Hoda Kamali
Street address
Shafa Medical Education Center, Kausar Blvd.
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 3211 5780
Fax
+98 34 3211 5780
Email
hoda_3303@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpoor
Street address
Research and Technology Office, at the beginning of Ibn Sina Street, Samiya Crossroads (Tahmasababad)
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Fax
+98 34 3226 3857
Email
iranpourabedin89@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mohadese Kamali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Persian medicine, University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
کرمان
Province
Kerman
Postal code
7616913555
Phone
+98 34 3133 6000
Email
mohadesekamali0912@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohadese Kamali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Persian medicine, University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3133 6000
Email
mohadesekamali0912@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohadese Kamali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Persian medicine, University of Medical Sciences campus, the beginning of Haft Bagh Alavi axis
City
کرمان
Province
Kerman
Postal code
7616913555
Phone
+98 34 3133 6000
Email
mohadesekamali0912@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Through the email of the person responsible for the general or scientific response of the study
When the data will become available and for how long
After printing and publishing the article
To whom data/document is available
Researchers in the specialized fields of neurology and Persian medicine
Under which criteria data/document could be used
On the condition of maintaining trust and citation
From where data/document is obtainable
Correspond with the email of the person responsible for the general or scientific response of this study.
What processes are involved for a request to access data/document
Correspondence with the email of the person responsible for the general or scientific response of this study