Clinical Study of Three Different Topical Formulations in Backache.
- Conditions
- Health Condition 1: null- Backache
- Registration Number
- CTRI/2016/03/006702
- Lead Sponsor
- Emami Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
1.Low Back Pain without any serious medical/surgical condition for a minimum period of six months.
2.History of Low Back Pain requiring the use of NSAIDs Acetaminophen, or another analgesic agent on a regular basis for at least six months before the screening visit
3.Subjects not having severe Lumbar joint deformity
4.Subjects signing written informed consent and ready to comply with the protocol requirement
5.Subjects with pain VAS > 40 mm on weight bearing activities
1.Rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
2.Subjects requiring Spine surgery within 6 months of screening
3.Use of any other investigational drug within 1 month prior to randomization
4.Subjects having uncontrolled diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease
5.Known other active and serious medical or surgical disease
6.Pregnancy and Lactation
7.Known hypersensitivity to ingredients used in study drug
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Assessment of Backache on VAS <br/ ><br>2.Assessment of Backache on Bournemouth Questionnaire <br/ ><br>Timepoint: Day 7, Day 14, Day 21, Day 28 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. Time of onset of action in relieving painful symptoms <br/ ><br>2. Duration of effect as a counter irritant and relief of painful symptoms <br/ ><br>3. Requirement of rescue medicines <br/ ><br>4. Global assessment for overall relief in painful symptoms by the subject at the end of study. <br/ ><br>5. Global assessment for overall effect by the investigator and Subject at the end of study <br/ ><br>6. Comparative evaluation of onset of action, duration, intensity and sensorial parameters <br/ ><br>7. Assessment of comparative safetyTimepoint: Day 7, Day 14, Day 21, Day 28 <br/ ><br>