Health Condition 1: M259- Joint disorder, unspecified
Conditions
Interventions
Intervention1: Amrutanjan advanced joint muscle Plus spray: Pudinah (Mentha arvensis - Aerial part, Satva) 9%
Gandhapura patra taila (Gaultheria fragrantissima- Lf, Ol) 30%
Karpura (Cinnamomum camphor
Sponsors
Amrutanjan Health Care Limited Tamil Nadu India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex aged above 18 years. 2. Patients 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. 3. Patients who had been diagnosed with acute and chronic localized musculoskeletal pain and joint pain disorders.
Exclusion criteria
Exclusion criteria: Patients presenting with any of the following will not be included in the trial. 1. Women of child bearing potential who are either unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (implants or injectable products, vaginal products, skin patches), or IUDs, barrier methods] to avoid pregnancy during the study period. 2. Subject with active skin lesions or other skin diseases. 3. Subject with history of uncontrolled diabetes (HbA1C of more than 9) 4. Known allergy to compounds of investigational product. 5. Fracture, Ligament tear, sports injury patient will be excluded 6. Subject undergoing physiotherapy session will be excluded. 7. Patients suffering from medical or psychiatric conditions that would increase the risk of adverse events or interfere with study assessments. 8. Participation in an investigational drug trial in the30 days prior to the screening visit. 9. Patients of vulnerable group (children, lactating mother, elderly >80 years, handicapped, seriously ill, mentally challenged). 10. History of drug or alcohol abuse during the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset of relief of pain [Time frame: 0-120 minutes post dose] Time to onset of cooling/warmth/tingling/burning sensation [Time frame: 0-120 minutes post dose] Time to achieve complete relief of pain [Time frame: 0-120 minutes post dose] Reduction in pain score on numeric pain rating scale AT REST [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 24 hours post dose] ïÆ?Ë? Reduction in pain score on numeric pain rating scale during MOVEMENT [Time frame: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 24 hours post dose] Timepoint: 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes and hourly upto 24 hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Time interval between onset of pain relief and the need for second application of test product for pain relief [Time frame: 0-24 hours] Subjectââ?¬â?¢s overall satisfaction for pain relief on a 7- point Likert Satisfaction scale [Time Frame: Day 1 to Day 10 post dose] User perception will be assessed with a 5- point Likert Satisfaction scale on the following points: 1. Ease of application, 2. Stickiness 3. Greasiness and 4. Ease of spreading. [Time Frame: Day 1 to Day 10 post dose] Number of patients requiring rescue medication [Time Frame: Day 1 to Day 10 post dose] To monitor for any adverse events during the study period and assess the quality of life using a pre-and post-feedback questionnaire. Timepoint: Day 1 to Day 10 | — |
Countries
India
Contacts
Public ContactDr Ramesh Kannan
PM Medical Centre & KI3, CRO
Outcome results
None listed