An Open Label, Single Arm Clinical Study to Evaluate the safety and efficacy of Sakriyam Pain Oil for the patients with Muscular pain
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. Change in SGA score
研究概览
简要总结
An In-vivo study, Each participant entering the trial will be assigned to a regimen of investigational product, and advised to take general precautions as needed.
This study for 30 days in which Day 0 (Visit 1/Screening) done for screening purpose and handover the IP to the Subjects, and measure SGA, WOMAC, Musculoskeletal Health , VAS , EQ-5D-5L
The next visits- day 15, and day 30 involve WOMAC, VAS , EQ-5D-5L , Musculoskeletal Health Questionnaires.
Investigational Product: Sakriyam Pain Oil
Age criteria- 18 to 65 years
Test Product: Sakriyam Pain Oil, Dose**:** Apply oil two times a day, Route of Administration: Topical
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects having Muscular pain.
- •Subjects from 18 to 65 years of age.
- •If female with childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
- •Subjects that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study.
- •Subjects willing to avoid participation in any other interventional clinical trial for the duration of the study.
排除标准
- •Subjects that are pregnant, breast feeding, or planning to get pregnant during the study.
- •Subjects that have participated in any other interventional clinical trial in the previous 30 days.
- •Subjects with known sensitivity to any of the constituents of the investigational product.
结局指标
主要结局
1. Change in SGA score
时间窗: Time Frame Day1, Day15 and Day30
2. Change in WOMAC score
时间窗: Time Frame Day1, Day15 and Day30
3. Change in Musculoskeletal Health score
时间窗: Time Frame Day1, Day15 and Day30
次要结局
- 1. Change in VAS score(2. Change in EQ-5D-5L Score)
研究者
Dr Manoj Sharma
GS Ayurveda Medical College & Hospital Pilkhuwa Hapur