None listed
Conditions
Interventions
Intervention1: NKAFE cream: herbal cream to be applied liberally at least twice a day on affected area for 7 days.
Control Intervention1: Placebo cream: placebo cream to be applied liberally at least
Sponsors
Endeavour Consumer Health
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or females aged of 19-65 years (both inclusive). 2. Participant with acute or chronic localized musculoskeletal pain or musculoskeletal discomfort. 3. Participant willing to give written informed consent. 4. Participant willing to come for visits at the site as per protocol. 5. Participant willing to use the investigational product as instructed per protocol.
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating women. 2. Use of any topical agents on the affected area within 3 days of screening or enrolment. 3. Subject with active skin lesions or skin disease or with cutaneous manifestations of systemic illnesses. 4. Subject with active cancer, spinal cord lesions or spine surgery. 5. Subject with history of alcohol or drug abuse within 1 year. 6. Subject with history of severe cardiac, liver or kidney disease or any other medical condition that may interfere with the ability of the subject to participate in the study as determined by the Investigator. 7. Patients already on oral NSAIDs or analgesics. 8. Contraindication or allergy to any substance in the investigational product. 9. Currently, or within the past 30 days, enrolled in a different clinical investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of change in pain score at rest (Visual Analog Scale), change in pain score in motion (Visual Analog Scale), muscle stiffness measured by Numerical Rating Scale (NRS), severity of pain on a 5-point rating scale of very severe, severe, moderate, mild and none, evaluation of severity of stiffness on a 5-point rating scale of very severe, severe, moderate, and mild and none.Timepoint: Baseline (Day 1) and End of study (Day 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability based on a four-point scale (0 3) for erythema, scaling, dryness, pruritus, and burning/stinging.Timepoint: End of study (Day 7);Patient Global Assessment of Treatment Tolerability (PGATT) (overall tolerability)Timepoint: End of study (Day 7);Treatment Emergent Adverse EventTimepoint: Randomization visit to End of Study | — |
Countries
India
Contacts
Public ContactMrs Aditi Vaidya
ProRelix Services LLP
Outcome results
None listed