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The effect of Curcumin on Oxidant , Antioxidant factors ,Liver ,Kidney tests serum , Clinical signs and symptoms of MultipleSclerosis patients

Protocol summary

Study aim
The effect of curcumin on oxidant , antioxidant factors , liver ,kidney tests serum , clinical signs and symptoms of multiple sclerosis patients
Design
Clinical practice with control group, parallel, double-blind, randomized, phase 3 over 96 patients, blocked randomization method
Settings and conduct
The clinics of Arak University of Medical Sciences will be double-blind and patients will be divided into two groups of cases and Dronoma as blocked randomization with 4 and 6 block sizes. The doctor's secretary (who has no knowledge of the type of capsules and the group of patients in which they are placed) will be given. Thus, the researcher, the specialist, the patient will be blinded.
Participants/Inclusion and exclusion criteria
Ms have RRMS, age 18 to 50, and EDSS (less than 4). Patients who have been diagnosed with MS for at least a year have no gastrointestinal problems. Don't take zinc supplements or selenium supplements. Anthocyanin-like corticosteroids, such as vitamin EA-D, haven't been used for at least the past two weeks. Don't be pregnant. Don't be breastfeeding women
Intervention groups
Razak 270 mg Corkomine Capsule, Stanoma Pharma Capsule Capsule
Main outcome variables
Total Oxidative Capacity, Oxygenated Water, Malondialdehyde, Revitalizing Glutathione, Dysmotaz Super Oxide, Alanine Amino Transfer, Aspartate Amino Transfer, Nitrogen Urea Blood, Blood Creatinine, Fatigue, gait disorders and severe disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200614047766N1
Registration date: 2020-06-30, 1399/04/10
Registration timing: prospective

Last update: 2020-06-30, 1399/04/10
Update count: 0
Registration date
2020-06-30, 1399/04/10
Registrant information
Name
Zahra Godarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3276 3822
Email address
kiyangolmohamadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-21, 1399/06/31
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
2020-09-21, 1399/06/31
Actual recruitment end date
2021-02-18, 1399/11/30
Trial completion date
2021-06-21, 1400/03/31
Scientific title
The effect of Curcumin on Oxidant , Antioxidant factors ,Liver ,Kidney tests serum , Clinical signs and symptoms of MultipleSclerosis patients
Public title
Investigation of the effect of curcumin in Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The study subjects must have RRMS type Ms disease They are 18 to 50 years old and EDSS (disease incapacity severity) must be less than 4 Patients who have been diagnosed with MS for at least one year Patients who do not have a specific digestive problem (gastric and duodenal ulcers, irritable bowel syndrome, indigestion) Not sensitive to curcumin They do not receive zinc or selenium supplements Antioxidant corticosteroids, such as vitamin E-A-D, have not been used for at least the past two weeks. They are not pregnant Don't be a breastfeeding woman They do not have special liver or kidney problems
Exclusion criteria:
Lack of willingness of the patient to continue cooperation patients with mental disorders
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 96
Actual sample size reached: 96
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with divided randomization with block sizes of 4 and 6 blocks will be divided into two groups of cases (MS patients who will receive curcumin in 48 people) and Dardonema (MS patients who will receive placebo in 48 people). In this way, we paste 96 randomly selected codes on 96 cans of capsules that are similar in color, shape and size, and after pouring the curcumin capsule and placebo capsule according to the codes in the cans, we put all the cans. Pour into a bag.
Blinding (investigator's opinion)
Double blinded
Blinding description
According to the codes we have, Razak's 370 mg curcumin capsules will initially be given twice daily to the CASE group and the placebo-containing placebo capsule to the placebo group by the doctor's secretary (who has no knowledge of the type of capsules or what group of patients are in which). In this way, the doctor, the researcher and the patient have no knowledge of the groups
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Deputy of Research and Technology, Payambar Azam University Complex, Basij Square, Sardasht St
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2020-06-08, 1399/03/19
Ethics committee reference number
IR.ARAKMU.REC1399.068

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system

Primary outcomes

1

Description
Total oxidative status
Timepoint
Measurement of total oxidative status at the beginning of the study (before the start of the intervention) and 3 months after the start of use of curcumin capsules
Method of measurement
Total Oxidative Status Measurement Kit

2

Description
Malone Dialdehyde
Timepoint
Measurement of malondialdehyde at the beginning of the study (before the intervention) and 3 months after the start of use of curcumin capsules
Method of measurement
Malon dialdehyde Measurement Kit

3

Description
آب اکسیژنه
Timepoint
Measurement of oxygenated water at the beginning of the study (before the start of the intervention) and 3 months after the start of taking curcumin capsules
Method of measurement
Oxygenated water measurement kit

4

Description
Super Oxide Dismutase
Timepoint
Measurement of dismutase superoxide at the beginning of the study (before the start of the intervention) and 3 months after the start of taking curcumin capsules
Method of measurement
Dysmotase Super Oxide Measurement Kit

5

Description
Glutathione Revival
Timepoint
Measurement of glutathione reductase at the beginning of the study (before the start of the intervention) and 3 months after the start of the use of curcumin capsules
Method of measurement
Glutathione Revitalization Measurement Kit

6

Description
Aspartate amino transferase
Timepoint
At the beginning of the study (before the start of the intervention) and 3 months after the start of taking curcumin
Method of measurement
Aspartate aminotransferase assay kit

7

Description
Alanin amino transferase
Timepoint
The beginning of the study (before the start of the intervention) and 3 months after the start of taking curcumin
Method of measurement
Alanine Amino Transfer Measurement Kit

8

Description
Blood creatinine
Timepoint
At the beginning of the study (before the start of the intervention) and 3 months after the start of taking curcumin
Method of measurement
Creatine measuring kit

9

Description
Nitrogen in the blood urea
Timepoint
At the beginning of the study and 3 months after taking curcumin
Method of measurement
Blood urea nitrogen measurement kit

Secondary outcomes

1

Description
Expanded Disability Status Scale
Timepoint
At the beginning of the study (before the start of the intervention) and 3 months after the start of taking curcumin capsules
Method of measurement
questionnaire

2

Description
Fatigue Severity Scale
Timepoint
At the beginning of the study (before the start of the intervention) and 3 months after the start of taking curcumin capsules
Method of measurement
questionnaire

3

Description
Gait disorder
Timepoint
At the beginning of the study (before the start of the intervention) and 3 months after the start of use of curcumin capsules
Method of measurement
25 foot test

Intervention groups

1

Description
Intervention group: Intervention group: MS patients who take Corkomine oral capsule for 3 months at a dose of 370 mg, take one a day at the beginning of the study and then take it twice a day. It has high antioxidant properties.
Category
Treatment - Drugs

2

Description
Control group: MS patients who receive placebo for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Kosar Clinic
Full name of responsible person
Zahra Goodarzi
Street address
No. 3634, Kosar specialized clinic, Seyedha mosque, Imam khomeini st, Arak
City
Arak
Province
Markazi
Postal code
3814113634
Phone
+98 86 3223 3823
Email
it.kousar@arakmu.ac.ir

2

Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Zahra Goodarzi
Street address
No.9589, Shahid Shiroudi St, Arak
City
Arak
Province
Markazi
Postal code
3813899589
Phone
+98 86 3240 2002
Email
farahaniheidar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
No.6341, Deputy of Research and Technology, University Complex of the Great Prophet, University of Medical Sciences, Basij Square, Sardasht St. Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Zahra Goodarzi
Position
University Student
Latest degree
Bachelor
Other areas of specialty/work
Biochemistry
Street address
No. 9881, 30 Shams Alley, Football Street
City
Arak
Province
Markazi
Postal code
3815899881
Phone
+98 86 3276 3858
Email
kiyangolmohamadi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Rezaei Ashtiani
Position
specialist
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
No.3345, Mir Ahmad Doctors Building,Adalat Alley, Shahid Beheshti St, Arak
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3223 9388
Email
farahaniheidar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Haidar Farahani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Biochemistry section, Medical School, University Complex of the Great Prophet, Basij Square, Sardasht St, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3520
Email
farahaniheidar@yahoo.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
Not applicable
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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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