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.

PUNARJAN AYURVEDA PRIVATE LIMITED0 个研究点目标入组 60 人开始时间: 待定最近更新: 2023年6月26日

试验速览

暂无简介。

•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.

•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.

发起方

PUNARJAN AYURVEDA PRIVATE LIMITED