Health Condition 1: G437- Chronic migraine without aura
Conditions
Interventions
Intervention1: treatment arm- T.Prednisolone: After randomisation, tablet Prednisolone is given in the dose of 1mg/kg body weight (max dose 60mg) once daily,that is 1mg/kg body weight OD dose, orally
Sponsors
National Institute of Mental Health and NeuroSciences
Eligibility
Inclusion criteria
Inclusion criteria: Chronic migraine patients meeting the criteria according to ICHD-3 (2013) on prophylaxis for a period of at least 3months.
Exclusion criteria
Exclusion criteria: -Medical conditions that increase the risk of steroid administration like-Diabetes Mellitus (operationally defined as FBS >140; PPBS >200mg/dl), Impaired glucose tolerance (postprandial glucose levels of 140 to 199 mg per dL), Impaired fasting glucose (glucose levels of 100 to 125 mg per dL in fasting patients), Active infections, Hypertension( >140/90mmHg),Chronic co-morbidities that might be affected by steroids or would make changes in the clinical or biochemical values that would likely unmask the blinding. Diagnosis of secondary headache, Complicated migraine, Beck Depression Inventory (BDI) >24 (moderate depression)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the frequency of headache days at 2weeks and 4weeksTimepoint: Change from baseline in the frequency of headache days at 2weeks and 4weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in- Frequency of headache episodes Frequency of migraine days Frequency of moderate/severe headache days Overall acute headache pain medication use Disability scores- (HIT)-6 score and MIDAS Adverse drug reactions (ADR include all adverse reactions irrespective of the treatment arm) Timepoint: At two and four weeks | — |
Countries
India
Contacts
Public ContactDipti Baskar
National Institute of Mental Health and Neuro-Sciences(NIMHANS)
Outcome results
None listed