Health Condition 1: G35- Multiple sclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Case Inclusion Criteria 1.A diagnosis of MS using revised McDonald criteria 2017 (appendix) 2.Either RRMS, SPMS or PPMS phenotypes. 3.Males or females, aged between 18 to 50 years 4.Indian origin 5.Fatigue as evaluated using Fatigue severity scale (FSS) with a mean score of 4 and above. 6.EDSS (Expanded Disability Status Scale) score between 0 and 5 (appendix) 7.Written informed consent
Exclusion criteria
Exclusion criteria: Case Exclusion Criteria 1.Enrollment in another trial. 2.Any condition which in the opinion of the investigator would render the patient unsuitable. 3.Any concurrent illness, disability, or clinically significant abnormality (including laboratory tests) that may prevent the subject from safely completing the assessments required by the protocol. 4. Exacerbation of MS within 30 days before study inclusion 5. Botox to lower limbs within 6 months before study 6. Denial of consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes: 1.Improvement on Fatigue severity score between baseline and 3 months. This will be assessed as the mean score change between the intervention and control groups between baseline and 3 months. 2.Proportion of patients who improve to mean FSS below 4 at 3 months Timepoint: Baseline and after 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes: The secondary outcomes will include change in MFIS (Modified fatigue impact score), 25 feet walk test, MSQOL (MS quality of life), SF 36, HAM A (Hamilton Anxiety), HAM D (Hamilton Depression), EDSS ambulation score (Expanded disability status score) between baseline and at 3 months Timepoint: Baseline and after 3 months | — |
Countries
India
Contacts
All India Institute of Medical Sciences New Delhi