Health Condition 1: G892- Chronic pain, not elsewhere classified
Conditions
Interventions
Intervention1: Amitriptyline , vitamin d: Amitriptyline 25 mg daily for 3 months
vitamin D 60,000 IU thrice/week for 4 weeks and then once / week for 8 weeks
Control Intervention1: Vitamin D, placebo:
Sponsors
Department of Biotechnology
Eligibility
Inclusion criteria
Inclusion criteria: (1) Fulfilling the ICHD-3 criteria of chronic tension-type headache (CTTH) (2) 18-50 years old. (3) Serum vitamin D ICHD-3 criteria of CTTH are A. Headache occurring on 1 5 days/month on average for >3 months (180 days/year), fulfilling criteria Bâ??D B. Lastng hours to days, or unremitting C. At least two of the following four characteristics: (1). Bilateral location (2). Pressing or tightening (non-pulsating) quality (3). Mild or moderate intensity (4). Not aggravated by routine physical activity such as walking or climbing stairs D. Both of the following: (1). No more than one of photophobia, phonopho bia or mild nausea (2). neither moderate or severe nausea nor vomiting E. Not better accounted for by another ICHD-3 diagnosis
Exclusion criteria
Exclusion criteria: (1) Less than 18 years â?? more than 50 years old. (2) Pregnant or breast-feeding women (3) Confounding neurological or general medical disorders (diabetes, thyroid disorder, hypertension, etc) (4) Treatment with drugs ot her than amitriptyline in the last 4 weeks Patients using any other drugs for any reasons would be excluded (5) Vitamin D supplementation in the last 2 weeks (6) History suggesô???ve of New daily persistent he adaches (NDPH) and associated Medication overuse headache (MOH) (7) Abnormal liver function tests and abnormal renal function tests. (8) Patents who are not willing to take part in the study. (9) Patients who have never been subjected to any neuroimaging for headaches.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of pain frequency in a month (i.e. reduction of pain-free days in a month). Fifty percent (50%) reduction of pain frequency will be considered as â??effectiveTimepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)To find out the reduction of requirements of abortive therapy for acute attacks (iii) To correlate the headache frequency with serum vitamin D levels (at baseline) (iv) To correlate the response of vitamin D supplementation with serum vitamin D levels (in follow up) (to see if improvement is related with the rise in serum vitamin D levels)Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactSanjay Prakash
Dept of Neurology, Smt.B K Shah Medical Institute Research Center, Sumandeep Vidyapeeth,
Outcome results
None listed