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
- 暂停
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 2. Change in WOMAC score
研究概览
简要总结
An Open Label, Single Arm Clinical Study to Evaluate the safety and efficacy of Sakriyam Pain Oil for the patients with Muscular pain.
Patients will be assigned to investigational product for 30 days, following up on 1st, 15th and 30th
Primary outcomes: 1. Musculoskeletal Health Questionnaire, 2. WOMAC, 3.SGA
Secondary outcomes: 1.VAS, 2. EQ-5D-5L
Subjects from 18 to 65 years of age.
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
2. Change in WOMAC score
时间窗: Time Frame Day1, Day15 and Day30
1. Change in SGA 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