None listed
Conditions
Interventions
Intervention1: HRUP-122101(Rumalaya Pain Patch).: Product Usage: Apply a patch on affected area or as directed by your physician. You can apply another succesive patch on the recurrence of pain. You w
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: Adults of either gender aged >=18 - =12 - 2. Subjects with acute musculoskeletal pain (Back ache, joints pain, neck pain, shoulder pain etc.), sprain, strains and/ or acute sports injury pain. 3. Subjects willing to sign informed consent/assent form and follow with the schedule. 4. Subjects who have not participated in similar kind of study in last 4 weeks. 5. Parents/ Guardians/ Caregivers of the children of aged >=12- <= 17 willing to sign written consent (as applicable) and follow the study procedure. Children also should be giving the written assent
Exclusion criteria
Exclusion criteria: Subjects with chronic pain like arthritis, gout, ankylosing spondylitis. 2. Subjects suffering from auto-immune disorders, spastic disorders, genetic disorders, and severe traumatic conditions. 3. Any evidence or history of hypersensitivity to any of the components in the HRUP-122101. 4. Any known skin disorder or presence of open wounds. 5. Subjects who are taking any additional topical therapy or systemic NSAIDs. 6. Clinical diagnosis of bruised, trauma, muscle damage. 7. Subjects with raw wounds, sutures, fractures, and hematoma. 8. Pregnant or lactating women/ women not willing to follow adequate standard contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time required for the onset of symptomatic relief and complete symptomatic relief. 2. Time duration of effective and lasting pain relief 3.Time required for next successive application. 4. Correlation of pain intensity using VAS scoring 5. Assessing overall feedback of product using questionnaire.Timepoint: 1. Patch application time to the time of onset of pain relief and complete pain relief post patch application 2. from 1st patch application time to the time of 2nd successive patch application 3. From 1st patch application to the time of next application 4.Before every patch application and post 48 hours of 1 patch application 5. Post 48 hours from 1st patch application. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not ApplicableTimepoint: Not Applicable | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed