Health Condition 1: M545- Low back pain Health Condition 2: M791- Myalgia Health Condition 3: M255- Pain in joint Health Condition 4: M796- Pain in limb, hand, foot, fingersand toes
Conditions
Interventions
Intervention1: PAF-3, 500mg soft gelatin capsules (Curcuma longa extract, Boswellia serrata extract & Sesame lignans): ROA - oral, 500 mg x 2 capsules as single dose daily for 7 days
Control Interven
Sponsors
Arjuna Natural Ltd Formerly Arjuna Natural Extracts Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult patient, Male or female between 18-65 years of age. 2.A score of 5 or above on the Numerical Rating Scale 3.Patients 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. 4.Willing to give voluntary informed consent.
Exclusion criteria
Exclusion criteria: 1.Patient with acute muscle spasms who need parenteral therapy, surgery or hospital admission for management. 2.Patients with Grade 2 & 3 sprain or strain. 3.Patients with known history of severe osteoarthritis and rheumatoid arthritis. 4.Patients 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). 5.Patients with open wounds infected skin or other conditions of broken skin, skin affected by infection with inflammations at the site of proposed action. 6.Patients with underlying dermatitis or dermatosis associated with the injury. 7.Use of any oral or topical analgesic, antipyretic, sedative or anti-inflammatory treatment, Use of any topical products, including topical medications, sunscreens, lotions, moisturizers, and cosmetic products at the site of pain within 1 week prior to study or during the study. 8.Prior use within 1 week of study any Ayurvedic, siddha, Unani or proprietary products for pain and inflammation. 9.Any contusions at the site of acute soft tissue injury intended for treatment. 10.Any kind of neuralgic pain, headache and/or chronic pain 11.Previous adverse reaction or known allergy to herbal drugs, NSAID, steroids or any other severe food allergies. 12. Pregnant or lactating. 13.Previous history of gastro-intestinal hemorrhage or perforation, active or recurrent peptic ulceration or peptic bleeding. 14.Subjects who are severe smokers and drinkers 15.Received an investigational drug or product or participated in an investigational drug study within a period of 30 days prior to receiving study medication. 16.Scheduled elective surgery or other invasive procedures during the period of study participation. 17.Subjects suffering with diabetes, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases an active infectious disease (HBV, HCV,HIV). 18.A current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders 19.Female Patients not willing to use a standard contraception like any intrauterine devices or barrier methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in intensity of pain from baseline at Day 1 to Day 3 as assessed by NRS. 2.Change in pain relief from baseline at day 1 to Day 3 as assessed by a categorical pain relief scale. Timepoint: Baseline, Day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in pain intensity, pain relief, patients global impression of change as assessed from the patient diary.Timepoint: Day 2 to Day 7;Onset of Analgesia at first dose-Time to perceptible pain relief and time to meaningful pain relief. Timepoint: Day 1;Quality of pain by McGill pain questionnaire.Timepoint: Baseline, Day 3, Day 7;SPID 6hoursTimepoint: Day 1 - every 30 minutes post dose up to 6 hours;TOTPAR 6 hoursTimepoint: Day 1-every 30 minutes post dose up to 6 hours | — |
Countries
India
Contacts
Public ContactSudha Raj
Arjuna Natural Ltd.
Outcome results
None listed