Health Condition 1: M709- Unspecified soft tissue disorder related to use, overuse and pressure
Conditions
Interventions
Intervention1: Libain Oil: Apply externally over the affected area three times daily for 15 days
Control Intervention1: Nil: Nil
Sponsors
Clinfound Clinical Research Services PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with acute inflammatory condition (within 72 hours of entry in the study) like sprain, strain, or contusion 2.Patients with a pain score > 5 on visual analog scale (VAS) 3.Patients ready to give written informed consent and willing to comply the study protocol
Exclusion criteria
Exclusion criteria: 1.Patients with an injury to the same body region within the prior 3 months or a lifetime history of 3 or more injuries to the injured body region. 2. Use of NSAIDs (including acetaminophen) within 24 hours,opioids within 7 days, long acting NSAIDs like piroxicam or naproxem since the injury, any topical medication since injury or corticosteroid drugs by any route of administration within 60 days of entry in the study 3.Patients with an open lesion or serious injury, including a fracture,nerve injury, and a tear of ligament, muscle, or cartilage 4.Known hypersensitivity or intolerance or allergic type reactions to curcumin, boswellia or acetaminophen. 5.History of known alcohol, analgesic or narcotic abuse within 2 years. 6.Sensitive skin and loss of skin at the application site. 7.Pregnant or lactating females or absence of effective contraceptive methods for females of childbearing potential. 8.Presence of any severe medical or psychological condition or chronic condition/inflammation/infection that in the opinion of the investigator would compromise the patientâ??s safety or successful participation in the study. 9.Participation in any other clinical study within 30 days of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in VAS score of pain experienced during normal activity in the preceding 24 hours at end of study as compared to baselineTimepoint: Day 1, Day 5, Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in VAS score of pain experienced during normal activity in the preceding 24 hours at end of Day 5 as compared to baselineTimepoint: Day 5, Day 15;Global tolerability at end of the study.Timepoint: Day 5, Day 15;Pain relief score (â??spontaneous pain reliefâ?? and â??pain relief during activity and movementâ??) at the end of studyTimepoint: Day 5, Day 15;Patients and investigators overall assessmentTimepoint: Day 5, Day 15;Total requirement of rescue analgesiaTimepoint: Day 5,Day 15;Treatment emergent adverse events â?? incidence and severityTimepoint: Day 5,Day 15 | — |
Countries
India
Contacts
Public ContactSaji Jose
Advanced Herbal Remedies Research Laboratories
Outcome results
None listed