A Single Centre, Randomized, Open Label, Single Arm, Non-Comparative, Phase III Clinical study to Evaluate the Efficacy, Safety and Tolerability of JODOACT Cream in patients with acute musculoskeletal pain

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: CONDITION: Health Condition 1: M958‐ Other specified acquired deformities of musculoskeletal system PRIMARY OUTCOME: Mean change in intensity of pain. ; ; ; Timepoint: Day 0 to Day 7 ; SECONDARY OUTCOME: Percentage of subjects achieving at‐least 50% reduction in pain. ; ; Timepoint: Day 0 to Day 7 INCLUSION CRITERIA: 1.Healthy male or non‐pregnant female aged >= 18 and <= 65 years. 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.
Epistemonikos ID: c5c519ef9346453ff40c6962e9fc040b9f1ed5e0
First added on: Feb 20, 2024