None listed
Conditions
Interventions
Intervention1: 1. Viopatch - Regular Size: 50 cm2 for Neck and Ankle
2. Viopatch - Large Size: 75 cm2 for Shoulder and Knee
3. Viopatch - XL Size: 200 cm2 for Back: 1. Neat
2. Neat
3. Neat
Control Int
Sponsors
Unexo Lifesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18 to 65 years (both inclusive) at the time of consent. 2) Sex: Male or non-pregnant/non-lactating females. 3) Females of Childbearing potential must have a negative urine pregnancy test performed on screening visit. 4) Subjects are having mild to severe acute pain (occurrence less than 48 hours) musculoskeletal pain (such as back pain, ankle pain, knee pain, shoulder pain, wrist pain) due to sprains, strains or sports injury. 5) Subjects are having VAS score >= 5 mm. [Mild >5 to Severe pain >100 mm]. 6) Subjects must be able to understand and provide written informed consent to participate in the study. 7) Subjects should be willing and able to follow the study directions to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Subjects with history of any active cardiology conditions, respiratory conditions, metabolic disorders, urogenital conditions, liver disease, rheumatoid conditions or any chronic diseases. 2) Pregnancy or lactation period. 3) Females with childbearing potential without contraceptive methods. 4) Known allergy to ingredients of the study medication. 5) Known hypersensitivity to Gandhpura Oil (Wintergreen Oil), menthol, camphor, eucalyptus oil, clove oil etc. or any of the excipients. 6) Current skin disorders/open wounds in the area to be treated. 7) History of Drug and Alcohol abuse. 8) Any patient, in the investigators opinion not considered suitable for enrolment. 9) Use of non-steroid anti-inflammatory drugs, analgesics (e.g. acetyl salicylic acid, paracetamol) or psychotropic agents in the week before the study. Subjects who have experienced, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in subjects. 10) Subjects with or without chronic asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by aspirin or other non-steroidal anti-inflammatory agents. 11) Participation in a clinical study within the previous 30 days. 12) Any relevant surgical treatment during the previous two months or planned during the study. 13) Subjects on any prescription medicines that might interfere with the study outcome. 14) Known history of positive HIV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Safety of product and Placebo after application, by Investigator and self-reported by subjects. 2 Compare and assess the pain relief ability of products in time after application of product and placebo using Scale. - Pain intensity - After application, pain intensity will be measured. - Overall pain relief in time after application, pain intensity will be measured. 3 Compare and assess pain relief ability of products after application of product and placebo using Scale.Timepoint: 1 After product application of 13 hours ± 15 mins 2 Pain intensity - before application - After patch application at 3 min, 6 min, 9 min, 12 min & 15 min, 15 ± 5 mins, 30 ± 5 mins, 45 ± 5 mins, 60 ± 5 mins, 90 ± 15 mins, 120 ± 15 mins - Overall pain relief after application at 3 hours ± 15 mins, 6 hours ± 15 mins, 9 hours ± 15 mins, 12 hours ± 15 mins and 13 hours ± 15 mins. 3 Pain relief ability before and after product application | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To evaluate irritation after patch removal. 2 Adhesion property of test product patch and placebo patch using adhesion scoring scale. 3 Subjectsâ?? perception on product usage and acceptance of test products along with subjective evaluation.Timepoint: 1 On Day 1 and 24 hours (plus or minus 2 hours) of patch removal on Day 2. 2 On Day 1 at 4hr, 8hr and 12hr respectively after patch application. 3 On Day 1 and Day 2. | — |
Countries
India
Contacts
Public ContactMs Maheshvari Patel
Cliantha Research
Outcome results
None listed