Health Condition 1: M190- Primary osteoarthritis of other joints
Conditions
Interventions
None listed
Sponsors
Emami Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult subject, Male or female between 18-65 years of age. 2. A score of 5cm or above on the NRS (at rest) 3. Subjects having Acute Musculoskeletal Pain e.g. musculoskeletal injuries (pain & inflammation), muscle cramps & symptoms associated with conditions such as osteoarthritis, sport injury, sprain, back pain, leg cramps, sciatica, frozen shoulder and spondylitis, myalgia, neck pain, limb pain, low back pain, joint pain, widespread musculoskeletal pain, painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles (including Grade 1 sprain or strain), not requiring admittance to hospital. 4. Willing to give voluntary informed consent.
Exclusion criteria
Exclusion criteria: 1. Subject with acute muscle spasms who need parenteral therapy, surgery or hospital admission for management. painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles. Subjects with Grade 2 & 3 sprain or strain. 2. Subjects with known history of rheumatoid arthritis. 3. Subjects with uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg). 4. Subjects with open wounds infected skin or other conditions of broken skin, skin affected by infection with inflammations at the site of proposed action. 5. Subjects underlying dermatitis or dermatosis associated with the injury. 6. Use of any oral or topical analgesic, antipyretic, sedative, anti-inflammatory, muscle relaxants or any other oral or topical medications which in the opinion of the investigator would influence the conduct and outcomes of the study. 7. Prior use within 1 week of study any Ayurvedic, siddha, Unani or proprietary products for pain and inflammation. 8. Any kind of neuralgic pain, headache and/or chronic pain 9. Previous adverse reaction or known allergy to herbal, NSAID, steroids or any other severe food allergies. 10. A known pregnancy or lactation 11. Previous history of gastro-intestinal hemorrhage or perforation, active or recurrent peptic ulceration or peptic bleeding. 12. Subjects who are severe smokers and drinkers 13. Received an investigational or product or participated in an investigational study within a period of 30 days prior to receiving study medication. 14. Scheduled elective surgery or other invasive procedures during the period of study participation. 15. Subjects with a history of diabetes, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases an active infectious disease (HBV, HCV, HIV) which in the opinion of the investigator would influence the conduct and outcomes of the study. 16. A current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.NRS (at rest) SPID6 (Sum of Pain intensity difference)Timepoint: [ Time Frame: day 1, day 7 and day 15] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Earliest onset of analgesia 2. NRS (on movement) SPID6 (Sum of Pain intensity difference) 3. NRS (on pressure) SPID6 (Sum of Pain intensity difference) 4. PRS (at rest) TOTPAR6 (Total Pain Relief) 5. PRS (on movement) TOTPAR6 (Total Pain Relief) 6. PRS (on pressure) TOTPAR6 (Total Pain Relief) 7. McGill Short Form QuestionnaireTimepoint: [ Time Frame: day 1, day 7 and day 15] | — |
Countries
India
Contacts
Public ContactYogendra Kumar Choudhary
Saveetha Medical College and Hospital SIMATS
Outcome results
None listed