Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1a

Percentage of Relapse-Free Subjects at Month 12 and Month 24

Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.

Time frame: Month 12 and 24

Annualized Relapse Rate at Month 12 and 24

Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition. Annualized relapse rate was calculated by dividing the total number of relapse events by the total number of days subjects participated in the study. This number was then multiplied by 365.25 to get an annualized rate.

Time frame: Month 12 and 24

Total Number of Reported Relapses at Month 3, 6, 12 and 24

Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition.

Time frame: Month 3, 6, 12 and 24

Percentage of Subjects Treated With Glucocorticoids Due to Relapses During 24 Months

Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition. Percentage of subjects treated with glucocorticoids due to relapses during 24 Months were reported here.

Time frame: Baseline up to Month 24

Percentage of Subjects Free From Expanded Disability Status Scale (EDSS) Progression at Month 12 and 24

Disability progression was assessed using EDSS. EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in multiple sclerosis (MS) . Overall scores ranges from 0.0 (normal) to 10.0 (death due to MS). Disability progression was defined as an increase of EDSS score of at least 1.0 point compared to baseline for subjects with an EDSS =\< 4.0. For subjects with an EDSS= 0 at baseline, EDSS progression was defined as an increase of EDSS score of at least 1.5 point. Percentage of subjects free from EDSS progression at Month 12 and 24 were reported

Time frame: Month 12 and 24

Hazard Ratio for Time to First Sustained Expanded Disability Status Scale (EDSS) Progression

EDSS progression is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Overall scores ranges from 0.0 (normal) to 10.0 (death due to MS). A sustained progression on EDSS score was defined as an EDSS progression confirmed into two consecutive assessment. EDSS values obtained during clinical attacks are not excluded for the assessment of EDSS progression. However, EDSS values obtained during MS attacks that are not confirmed after two consecutive assessments will be excluded from statistical analysis of confirmed EDSS progression. Hazard ratio for time to first sustained EDSS progression was planned to be reported as per SAP.

Time frame: Baseline to date at which the first confirmed EDSS progression occurs, assessed up to 24 months

Percentage of Subjects With Active (New/Enlarging) T2 Lesions at Month 24

A single T2 lesion was defined as an area of increased signal on a given 3-millimeters axial image that was not referable to normally hyperintense structures. New T2 lesions were those that appear in areas where on the previous scan no abnormality was detected. All T2 lesions were detected by an MRI scan.

Time frame: Month 24

Percentage of Subjects With Combined Unique Active (CUA) Lesions at Month 12 and 24

CUA lesion was defined as new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting.

Time frame: Month 12 and 24

Mean Number of New Gadolinium (Gd)-Enhancing Lesions at Month 12 and 24

New Gd-enhancing Lesions are a measure of inflammatory activity and were assessed using the Magnetic Resonance Imaging (MRI) scan.

Time frame: Month 12 and 24

Mean Number of New T1 (Hypointense) Lesions at Month 12 and 24

Mean number of new T1 (Hypointense) Lesions represents a measure of accumulation of inflammatory disease burden assessed on magnetic resonance imaging (MRI) scans.

Time frame: Month 12 and 24

Cumulative Number of New T1 (Hypointense) Lesions

Cumulative number of new T1 (Hypointense) lesions were reported.

Time frame: Baseline up to Month 24

Median Change From Baseline in Whole Brain Volume at Month 12 and 24

Brain tissue volumes are inter-related and represent a measure of neurodegenerative aspects of the disease.

Time frame: Baseline, Month 12 and 24

Median Change From Baseline in Regional Brain Volume at Month 12 and 24

Brain tissue volumes are inter-related and represent a measure of neurodegenerative aspects of the disease.

Time frame: Baseline, Month 12 and 24

Flu-like Symptoms (FLS) Assessed by FLS Scale Score

Flu-like symptoms were measured using FLS score in which subjects were scored as per the presence and intensity of muscle aches, chills, and weakness, each separately, on a scale of 0-3 as follows: 0 = absent; 1 = mild, do not interfere with daily activities; 2 = moderate, sufficient to interfere with daily activities; and 3 = severe, bed rest require. Body temperature also was also recorded to determine the presence of fever using the following scale: 0 (≤ 37.2 °C); 1 (≥ 37.3 °C but \< 37.8 °C); 2 (≥ 37.8 but \< 38.4 °C); and 3 (≥ 38.4 °C).The scores for each symptom (muscle aches, chills, weakness, body temperature) was added together to provide the combined flu-like symptom score ranging from 0 to 12 where 0 indicates absence of any symptom and 12 indicates the worst severity of the symptoms.

Time frame: Screening, Baseline, Month 3, 6, 12 and 24

Number of Subjects With Treatment Emergent Adverse Event (TEAE), Serious AE (SAE), TEAE Leading to Death and Discontinuation

AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 24 months. TEAEs include both Serious TEAEs and non-serious TEAEs.

Time frame: Baseline up to Month 24

Number of Subjects With Clinical Significant Abnormality in Laboratory Parameters

Laboratory assessment included haematology, chemistry, and urinalysis. Clinical significance was determined by the investigator.

Time frame: From screening up to Month 24

Number of Subjects With One Concomitant Medication From Baseline up to Month 24

Number of subjects with at least one concomitant medication from baseline up to month 24 were reported.

Time frame: Baseline up to Month 24

Time on Treatment (Adherence to Treatment)

Time up to which subjects were adhered to the treatment was reported.

Time frame: Baseline up to 2.2 years

Number of Subjects With Premature Termination From Treatment

Number of subjects with premature termination from treatment were reported.

Time frame: Baseline up to Month 24

Hazard Ratio for Time to First Documented Relapse

Relapse was defined as the development of new or the exacerbation of existing neurological symptoms or signs, in the absence of fever, lasting for 24 hours and with a previous period for more than 30 days with a stable or an improving condition. Hazard ratio for time to first documented relapse was planned to be reported as per SAP.

Time frame: Baseline up to Date at which first Relapse Occurs assessed up to 24 months