Health Condition 1: J00- Acute nasopharyngitis [common cold]
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Participants who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily Participants clinically diagnosed with one of the following: -Headache (tension-type or non-migraine headache) - as per The International Classification of Headache Disorders 3rd edition (ICHD-3) criteria Nasal congestion due to common cold or allergic rhinitis Acute joint sprain (Grade 1 or mild or Grade 2) Participants with pain score grater then equal 3/10 (based on numeric pain rating scale) during the past 1 week.
Exclusion criteria
Exclusion criteria: Severe headache disorders (e.g., migraine, cluster headache) Nasal polyps, or active nasal infections Severe joint injuries (Grade 3 sprain, fractures, or dislocations) Broken skin, wounds, dermatitis, or active skin infections at the application site Use of other topical analgesics, nasal decongestants, or pain relief products at the application site during the study period Use of systemic analgesics, steroids, or muscle relaxants that may interfere with study outcomes Participation in an investigational drug trial during the last 30 days. Immuno-compromised (history) individuals including known HIV positive participants or participants who are on treatment with steroids or immunomodulators. Known hypersensitivity or allergy to any ingredient of Sanjeevanam Roll-On Participants of vulnerable group (e.g. seriously ill, mentally challenged). Pregnant or lactating women History of drug or alcohol abuse during the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset of relief of pain Time to achieve complete relief of pain Reduction in pain score on numeric pain rating scale (VAS) Assessment of pain relief by using McGill Pain questionnaire. Symptom-specific assessments for each arm: Based on complete relief of pain. Headache relief score Nasal congestion relief score (VAS score) Joint pain and functional improvement score Participant s overall satisfaction for pain relief on a 7- point Likert Satisfaction scale SF12 quality of life scoring Participant Global Assessment of EffectivenessTimepoint: 0 mins to 120 mins ,day 0, day 2 and day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AE) will be monitored throughout the study periodTimepoint: day 0, day 2 and day 7 - post dose | — |
Countries
India
Contacts
DK Elite Health Care Centre