A Randomized, Open label, single arm, Interventional study to evaluate the Efficacy andtolerability of Amrutanjan advanced joint muscle plus spray for pain relief in patients withMusculo-skeletal and joint pain disorders.

Amrutanjan Health Care Limited Tamil Nadu India1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2021年1月10日最近更新: 2021年2月12日

试验速览

阶段: 1/2 期
状态: 已完成
发起方
入组人数: 24
试验地点: 1
主要终点: Time to onset of relief of pain [Time frame: 0-120 minutes post dose]

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study selected participants (24 subjects) will receive treatment as follows: Test arm 1 : (musculoskeletal pain) Amrutanjan advanced joint muscle + spray 24 subjects. The study participants will be requested to hold the spray device 6 inches away from the affected area and spray 3 to 4 times a day. If they have no relief after 2 hrs of spray application, they were permitted to use rescue medications. The participant will be asked to visit clinical facility/institution for their follow up visits on day 2 and day 10

研究设计

研究类型: Interventional
分配方式: Not Applicable
盲法: Not Applicable

入排标准

年龄范围: 18.00 Year(s) 至 80.00 Year(s)（—）
性别: All

入选标准

•1.Patients of either sex aged above 18 years.
•2.Patients who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily.
•3.Patients who had been diagnosed with acute and chronic localized musculoskeletal pain and joint pain disorders.

排除标准

•Patients presenting with any of the following will not be included in the trial.
•1.Women of child bearing potential who are either unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (implants or injectable products, vaginal products, skin patches), or IUDs, barrier methods] to avoid pregnancy during the study period.
•2.Subject with active skin lesions or other skin diseases.
•3.Subject with history of uncontrolled diabetes (HbA1C of more than 9) 4.Known allergy to compounds of investigational product.
•5.Fracture, Ligament tear, sports injury patient will be excluded 6.Subject undergoing physiotherapy session will be excluded.
•7.Patients suffering from medical or psychiatric conditions that would increase the risk of adverse events or interfere with study assessments.
•8.Participation in an investigational drug trial in the30 days prior to the screening visit.
•9.Patients of vulnerable group (children, lactating mother, elderly >80 years, handicapped, seriously ill, mentally challenged).
•10.History of drug or alcohol abuse during the last 6 months.