Health Condition 1: M638- Disorders of muscle in diseases classified elsewhere
Conditions
Interventions
Intervention1: Nano Carrier Entrapped Vitamin D3 Oral Dispersion 60000 IU (Pulse Pharmaceuticals Pvt. Ltd.): Each 5ml Syrup contains: Cholecalciferol 60000 IU
Dose and Frequency: 5ml Syrup will be ad
Sponsors
Pulse Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: i.Vitamin D insufficient patients of either gender, aged between 18â??75 years with CLBP of 03-months or more with or without leg pain. ii.Vitamin D insufficiency will be identified with estimation of 25(OH)D in blood. Levels below 29 ng/ ml will be considered as vitamin D insufficiency. iii.The diagnosis of CLBP would be established based on signs, symptoms and MRI. iv.Patients are required to have language competency (English, Telugu, Kanada or Hindi) in order to complete the study related questionnaires which include a Modified Oswestry Disability Questionnaire (MODQ) to measure functional disability, work status, and the use of medication, and a visual analogue scale (VAS) to measure pain intensity. v.Patients having a pain score of atleast 05 as assessed on Visual Analogue Scale (VAS) at baseline. vi.Patients are required to have stable pain score for 03-months before recruitment and could be on any oral analgesic therapy. vii.Patients not responding to any medication and physical therapies. viii.Record will be made of patient history, physical examination, and laboratory tests. ix.Women of childbearing potential are required to receive a highly effective form of contraception. x.Subject and legally acceptable representative (LAR) are able to attend all scheduled visits and to comply with all trial procedures. xi.All patients will provide signed Informed Consent.
Exclusion criteria
Exclusion criteria: i.Patients who have taken Vitamin D supplementation during past 03-months. ii.Patients with a prior radiologically confirmed diagnosis of spondylolisthesis, disc herniation, spinal canal stenosis, vertebral compression fracture, spinal malformation or spinal injury. iii.Patients with a past history of spinal surgery. iv.Patients with established spinal tuberculosis or other spinal infections, malignancy, rheumatic disorder, osteomalacia, osteoporosis, osteoarthritis and metabolic bone disease (hypo- or hyperparathyroidism). v.Patients of diabetes mellitus, epilepsy, psychiatric diseases, substance abuse disorder, chronic renal disease, and medical or surgical disorders affecting Vitamin D metabolism (gastric surgery, chronic liver disease, renal failure, intestinal malabsorption, systemic infections, cancers etc.). vi. Neuropathic Pain Conditions are ruled out by using DN4 Questionnaire on screening day. vii.Malabsorption conditions such as Celiac disease are ruled out by Celiac Disease Questionnaire. viii.Patients consuming drugs altering bone metabolism like corticosteroid or bisphosphonates. ix.Pregnant and lactating mothers, and women intending pregnancy. x.Patients diagnosed with Illness/ infection on the day of the inclusion. xi.Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢To compare any change in Cholecalciferol and 25-hydroxy cholecalciferol {25(OH)D} levels after administration of various study formulations. â?¢To compare any change in Parathyroid hormone (PTH, intact) levels after administration of various study formulation.Timepoint: Baseline, Day 10 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢To evaluate pain intensity in patients with CLBP before and after the addition of Vitamin D to standard therapy using a 10-point Visual Analogue Scale (VAS). â?¢To evaluate functional disability in patients with CLBP before and after the addition of Vitamin D to the standard therapy using Modified Oswestry Disability Questionnaire (MODQ).Timepoint: Baseline,Day 10 and Day 30 | — |
Countries
India
Contacts
Public ContactDr Raj Kumar S Amaravati
St. Johns Medical College Hospital
Outcome results
None listed