Protocol summary

Summary
In this double-blind randomized clinical trial, 60 patients with probable or definite ALS based on revised El Escorial criteria referred to Imam Khomeini hospital between March 2015 and 2016,will be studied. An age range of 18 to 85 years, time has passed since the onset of the symptoms till inclusion 2 years or less and mild to moderate disability based on ALSFRS-r is the inclusion criteria and familial ALS in first-degree relatives, pregnancy or breastfeeding and severe renal, liver or heart dysfunction are the major exclusion criteria. All participants will sign the informed consent prior to inclusion in the study. Patients will receive either 80 milligrams of Curcumin sina capsules (30 patients) or placebo (30 patients) besides Rilozule for 3 months. In order to avoid gastrointestinal side effects of Curcumin, anti-acids will be prescribed for the patients. Patients clinical status will be evaluated by compound muscle action potential (CMAP) in ulnar and proneal nerves and functional status of the patients will be evaluated by revised ALS Functional Rating Scale (ALSFRS-r), manual muscle testing (MMT) and amyotrophic lateral sclerosis assessment questionnaire (ALSAQ-40); medication side effects will be assessed during this 3 months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015062411424N3
Registration date: 2016-07-01, 1395/04/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-07-01, 1395/04/11
Registrant information
Name
Abbas Tafakhori
Name of organization / entity
Iranian Center of Neurological Research
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 0491
Email address
a_tafakhori@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of Curcumin in patients with amyotrophic lateral sclerosis reffered to neurologic research center of imam khomeini hospital
Public title
Therapeutic effects of Curcumin capsule in patients with amyotrophic lateral sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with an age range of 18 to 85; Probable or definite ALS (based on revised El Escorial criteria); Time passed since onset of the symptoms till inclusion be 2 years or less; Mild to moderate disability (based on ALSFRS-r) Exclusion criteria: Familial ALS in first-degree relatives; Pregnancy or breastfeeding; Severe renal, liver or heart dysfunction; HIV positive patients; Prominant cognitive impairment
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Sciences
Street address
Tehran University of Medical Sciences, Qods Street, Keshavarz blv.
City
Tehran
Postal code
Approval date
2016-05-30, 1395/03/10
Ethics committee reference number
IR.TUMS.REC.1395.2646

Health conditions studied

1

Description of health condition studied
Amyotrophic lateral sclerosis(AlS)
ICD-10 code
G12.2
ICD-10 code description
Motor neuron disease

Primary outcomes

1

Description
patients clinical function changes
Timepoint
baseline,3 months after intervention
Method of measurement
ALS Functional Rating Scale

Secondary outcomes

1

Description
compound muscle action potential (CMAP) changes in ulnar nerve
Timepoint
baseline, 3 months after intervention
Method of measurement
EMG-NCV

2

Description
muscle strength changes
Timepoint
baseline, 3 months after intervention
Method of measurement
Manual muscle testing

3

Description
compound muscle action potential (CMAP) changes in proneal nerve
Timepoint
baseline, 3 months after intervention
Method of measurement
EMG-NCV

4

Description
quality of life
Timepoint
baseline, 3 months after intervention
Method of measurement
ALSAQ-40

5

Description
medication side effects
Timepoint
3 months after intervention
Method of measurement
questionnaire

Intervention groups

1

Description
Control: In this group, patients will recieve capsule placebo daily besides tablet Riluzole 50mg BD
Category
Placebo

2

Description
Intervention: In this group, patients will recieve capsule Sina Curcumin 80 mg daily and tablet Riluzole 50mg BD
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Abbas Tafakhori
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masood Yunesian
Street address
Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Abbas Tafakhori
Position
Neurologist
Other areas of specialty/work
Street address
Imam Khomeini hospital, End of Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2424
Fax
Email
abbas.tafakhori@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Tafakhori
Position
Neurologist
Other areas of specialty/work
Street address
Imam Khomeini hospital, End of Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2424
Fax
Email
abbas.tafakhori@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elmira Agah
Position
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Qods Street, Keshavarz Blvd.
City
Postal code
Phone
00
Fax
Email
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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