None listed
Conditions
Interventions
Intervention1: PFK300: 1 capsule of 500mg of PFK300 (Turmeric extract, Boswellia serrata extract, sesame oil) in the morning for 1 day.
Control Intervention1: Placebo: 1 capsule of 500mg of Placebo (M
Sponsors
Arjuna Natural Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Adult subject, Male or female between 18-65 years of age. A score of 5cm or above on the NRS Scale. Subjects having acute musculoskeletal pain which occurred within 24 hours before presentation e.g. musculoskeletal injuries, 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. Willing to give voluntary informed consent.
Exclusion criteria
Exclusion criteria: 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. Subjects with known history of osteoarthritis and rheumatoid arthritis. 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). Subjects with open wounds infected skin or other conditions of broken skin, skin affected by infection with inflammations at the site of proposed action. Subjects underlying dermatitis or dermatosis associated with the injury. 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. Prior use within 1 week of study any Ayurvedic, siddha, Unani or proprietary products for pain and inflammation. Any kind of neuralgic pain, headache and/or chronic pain Previous adverse reaction or known allergy to herbal, NSAID, steroids or any other severe food allergies. A known pregnancy or lactation Previous history of gastro-intestinal hemorrhage or perforation, active or recurrent peptic ulceration or peptic bleeding. Subjects who are severe smokers and drinkers Received an investigational or product or participated in an investigational study within a period of 30 days prior to receiving study medication. Scheduled elective surgery or other invasive procedures during the period of study participation. 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. 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. TOTPAR calculated as the weighted sum of the PRS scores 2. SPID calculated as the weighted sum of the NRS scoresTimepoint: 1. Pain relief score taken at post-dose 30 min, 1hr, 1.5hr, 2 hr, 2.5hr, 3 hr, 3.5hr, 4 hr, 4.5hr, 5hr, 5.5hr, & 6hr. 2. Pain intensity score taken at baseline, post-dose 30 min, 1hr, 1.5hr, 2 hr, 2.5hr, 3 hr, 3.5hr, 4 hr, 4.5hr, 5hr, 5.5hr, & 6hr. | — |
Secondary
| Measure | Time frame |
|---|---|
| Earliest onset of pain reliefTimepoint: From post-dose to censored at 6hrs;McGill Short Form QuestionnaireTimepoint: Screening and after 6h post dose. | — |
Countries
India
Contacts
Public ContactDr Binu T Kuruvilla
Arjuna Natural Pvt Ltd (formerly Arjuna Natural Ltd)
Outcome results
None listed