Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system
Conditions
Interventions
None listed
Sponsors
PUNARJAN AYURVEDA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male or non-pregnant female aged >= 18 and 2.Patient with acute painful musculoskeletal pain (Eg. musculoskeletal injuries, myalgia, neck pain, limb pain, low back pain) 3.Patient with mild to moderate pain as measured by a 100 mm VAS (10 mm - 60 mm both inclusive). 4.In case of women, postmenopausal ( > 12 months without menstrual bleeding), Surgically sterilized, or on use of effective birth control measures. 5.Willingness to sign written informed consent document.
Exclusion criteria
Exclusion criteria: 1.Women of childbearing potential if pregnant (test positive for pregnancy) at screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. 2.Patients with abrasions, lacerations, fractures, open wounds, infected skin or other conditions of broken skin, skin affected by infection, inflammations at the site of proposed application and around the area of affliction. 3.Patients with known hypersensitivity to any component of study medication. 4.Use of any oral or topical analgesic or anti-inflammatory treatment in the previous 24 hrs. prior to study entry and or during study period. 5.Patients with painful musculoskeletal conditions, who need parenteral therapy I surgery I hospital admission for management. 6.History of aspirin-sensitive asthma, adverse reaction to oral nonsteroidal anti-inflammatory drug (NSAID), bleeding diathesis. 7.Presence of any clinically relevant disease/disorder (e.g., severe hepatic impairment, chronic renal failure, thromboembolic disorders, acute myocardial infarction or cerebrovascular diseases, uncontrolled diabetes, uncontrolled thyroid disorder etc.). 8.Any condition that, in the opinion of the Investigator, could affect study parameters. 9.Subject with known allergy or hypersensitivity to the components of the formulation. 10.Participation in another clinical trial within past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in intensity of pain. Timepoint: Day 0 to Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving at-least 50% reduction in pain. Timepoint: Day 0 to Day 7 | — |
Countries
India
Contacts
Public ContactDr K Naresh Chandra
PUNARJAN AYURVEDA PRIVATE LIMITED
Outcome results
None listed