Health Condition 1: null- Patients Suffering with Acute Musculoskeletal Spasm Associated with Low Backache
Conditions
Interventions
Intervention1: Eperisone and Diclofenac: 150mg thrice a day for seven days.
Control Intervention1: Eperisone: 50mg thrice a day for seven days.
Sponsors
Inventia Health Care Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Ages Eligible for Study: 18 Years to 70 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Patients of either sex between 18 to 70 years of age. Patients with confirmed diagnosis of Acute Musculoskeletal spasm with Low Back Pain due to Spondylosis deformans, Prolapsed Intervertebral Disc (PID),- Muscle sprains with spasms. Patients who are willing to take the medications as directed and willing to come for follow-ups. Patients who are willing to comply with the protocol requirements. Patients who are willing to give the written informed consent.
Exclusion criteria
Exclusion criteria: Patients with other associated spasm conditions like: Traumatic pain with spasms, Cervical Spondylitis and Pain & spasm associated with fractured bone. Patients who had taken any form of skeletal muscle relaxant in the previous 7 days. Patients with hypersensitivity to any of the ingredients of the study drug formulations. Pregnant or Lactating women or women of child bearing potential not following adequate contraceptive measures. Patients unwilling or unable to comply with the study procedures. Patients having a history of severe acute infection, major surgery or trauma, severe metabolic, endocrine or electrolyte disturbances and seizures in preceding 8 weeks. Patients having any of the following disorders: Renal failure, Bulimia, Hypo and Hyperthyroidism Nephrotic syndrome. Patients having uncontrolled diabetes mellitus, or any other metabolic or endocrine disorder. Patients that have received treatment with any investigational drug in the preceding 4 weeks. Patients likely to be non-compliant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison percent of reduction in pain within the last 24 hours assessed using VAS at Day 4 in both treatment groupsTimepoint: Day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Average reduction pain within the last 24 hours assessed using VAS by Investigator and Subject at day 7 i.e. completion of protocol treatment in both treatment groups.Timepoint: Day 7 | — |
Countries
India
Contacts
Public ContactGautam Saranath
NEXUS CLINICAL RESEARCH (INDIA) LTD.
Outcome results
None listed