A randomized, open label, comparative, clinical study to evaluate the efficacy and safety of TRUBLISS PAIN RELIEF OIL in patients with musculo-skeletal and joint pain disorders

Trubliss International2 sites in 1 country30 target enrollmentStarted: August 23, 2024Last updated: August 24, 2024

Overview

Phase: Phase 3
Status: Completed
Sponsor: Trubliss International
Enrollment: 30
Locations: 2
Primary Endpoint: 1. Time to onset of relief of pain [Time frame: 0-120 minutes post dose]

Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Overview

Brief Summary

Participants will be randomized into two groups of 15 each: Arm 1: Participants with musculoskeletal and joint pain will use TRUBLISS PAIN RELIEF Oil twice daily for 2 weeks. Arm 2: Participants with musculoskeletal and joint pain will use Dr Ortho Oil twice daily for 2 weeks. Primary Endpoints

Time to pain relief onset (0-120 minutes post-dose).
Time to onset of cooling/warmth/tingling/burning sensations (0-120 minutes post-dose).
Time to complete pain relief (0-120 minutes post-dose).
Pain reduction at rest (measured at various intervals up to 8 hours post-dose).
Pain reduction during movement (measured at various intervals up to 8 hours post-dose).
Change in pain intensity from baseline to 2 weeks (measured by Pain VAS Scale).
Time between pain relief onset and need for second application (0-24 hours).
Overall satisfaction with pain relief (7-point Likert scale from Day 1 to Day 14).
User perceptions of ease of application, stickiness, greasiness, and spread ability (5-point Likert scale from Day 1 to Day 14).
Number of patients requiring rescue medication (Day 1 to Day 14).
Changes in laboratory parameters for arthritis (C-Reactive Protein, ESR) from baseline to 2 weeks.
Quality of life changes (Short Form Health-12) from baseline to 2 weeks. Secondary Endpoint Safety and tolerability, assessed by adverse events (AEs) and serious adverse events (SAEs) during the study period and brief clinical examinations. Data will be compared between TRUBLISS PAIN RELIEF OIL and Dr ORTHO OIL.

Study Design

Study Type: Interventional
Allocation: Randomized
Masking: None

Eligibility Criteria

Ages: 18.00 Year(s) to 60.00 Year(s) (—)
Sex: All

Inclusion Criteria

•Patients of either sex aged above 18 years.
•Patients who can 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.
•Patients who have been diagnosed with acute and chronic localized musculoskeletal pain and joint pain (arthritis) disorders.

Exclusion Criteria

•Women of childbearing potential who are either unwilling or unable to use an acceptable method of birth control to avoid pregnancy during the study period.
•Subject with active skin lesions or other skin diseases.
•Subject with history of uncontrolled diabetes
•Known allergy to compounds of investigational product.
•Participation in an investigational drug trial in the 30 days prior to the screening visit.
•Patients of vulnerable group (children, lactating mother, elderly greater than 80 years, handicapped, seriously ill, mentally challenged).
•History of drug or alcohol abuse during the last 6 months.