A Single Centric, Open-Label, Non-Randomized Phase IV Post-Marketing Surveillance Study to Measure the Efficacy and Safety of Dr.Ortho Pain Relief Oil in Subjects Suffering from Acute Sports Injury, Knee Pain, Stiffness in Joints, Lower Back Pain, Neck Rigidity, Backache and Inflammation in Joints
试验速览
- 阶段
- Unknown
- 状态
- 进行中(未招募)
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. To assess the percentage of subjects with significant symptomatic reduction of joint muscle stiffness, neck rigidity, and backache assessed through Investigator Assessment Scale and Subject Assessment Questionnaires
研究概览
简要总结
The Study has been designed to measure the efficacy and safety of Dr. Ortho Pain Relief Oil in subjects suffering from Acute Sports Injury, Knee Pain, Stiffness in joints, Lower Back Pain, Neck Rigidity, Backache and Inflammation in Joints. The Study is an single centric, open label, Non-randomized, Phase IV Post marketing surveillance study on 120 subjects. There are three visits in the study with one being telephonic follow-up. On screening visit i.e., day 1, the subjects will be screened based on inclusion and exclusion criteria. an informed consent form will be given to all subjects at the screening visit containing all study information in it. Eligible subjects will be enrolled in the study after informed consent procedure and will be briefed about all study related procedure in detail. The site Investigator will explain the subject about all study related process and the visit 2 – Day 15 and Visit 3 Day 30 (Final Visit). All eligible subjects will then be provided with Test Product – Dr. Ortho Oil by Investigator/study coordinator. In the presence of Investigator, the instructions will be given to use the test product at home from Day 1 to Day 30 i.e., 5 to 10 ml of topical application of Dr. Ortho Oil and gently massage the affected area twice a day. Investigator assessment shall be performed on Baseline Day 0 and final visit- Day 30. A self- assessment questionnaire shall be given to all eligible subjects on Baseline- Day 0 and final visit- Day 30.
研究设计
- 研究类型
- Observational
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.Age Between
- •80 Years 2.Subjects suffering from Knee pain and joint pain and arthritis
- •Willingness to Take part in Study and able to attend all Scheduled Visits 4.Subjects suffering from Acute sports injury, strains, sprain, chronic Arthritis, back pain, knee pain, and other joint pain.
排除标准
- •1.Pregnant, Breastfeeding, subjects undergone any surgery and else take taken part in any clinical Trial 2.Not willing to Sign the ICF or give the consent.
结局指标
主要结局
1. To assess the percentage of subjects with significant symptomatic reduction of joint muscle stiffness, neck rigidity, and backache assessed through Investigator Assessment Scale and Subject Assessment Questionnaires
时间窗: Day 1 to day 30
次要结局
- 1.Improvement in the VAS scoring on the successive application as compared to baseline(2.Incidence of any AEs during the study)
