RETROSPECTIVE, CROSS SECTIONAL AND PROSPECTIVE OBSEVATIONAL STUDY TOEVALUATE ORTHOHERB OIL THROUGH POST MARKETING SURVEILLANCE STUDY
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- 2.Ensuring safety of Orthoherb oil on prolonged use.
研究概览
简要总结
This study aimed to ensure and reconfirm the qualityand efficacy of Orthoherb oil available in the market in different regions ofIndia, To monitor the safety of Orthoherb oil on prolonged use and To evaluatethe adverse drug reactions (ADR), adverse effects (AE) and additional benefitsreporting by patients. PMS will be conducted as Survey across the subjects byquestionnaire method. Validated Questionnaire covering safety, efficacy,financial parameters, AE and ADR will be provided to the users of Orthoherb oil.The data thus gathered will be analyzed through appropriate statisticalmethods.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 35.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age: 35 -70 years 2.Willing to applying Orthoherb oil externally at least one time per day for a continuous period of 6 months 3.Having one or more joint pain 4.Willing to enrol in study by signing Informed consent.
排除标准
- •1.Earlier participation in this study 2.Subjects using Orthoherb oil since more than two months 3.Pain is of acute onset or due to trauma/injury 4.Unable to respond properly for questionnaire or when a patient is too severely ill to answer the questions.
结局指标
主要结局
2.Ensuring safety of Orthoherb oil on prolonged use.
时间窗: oth-baseline | 1st-first response to questionnaire and 2nd -response at the end of the study
3.Incidence of adverse effects or adverse events in users of Orthoherb oil
时间窗: oth-baseline | 1st-first response to questionnaire and 2nd -response at the end of the study
1.Reconfirming the efficacy of Orthoherb oil in joint pain and disorders.
时间窗: oth-baseline | 1st-first response to questionnaire and 2nd -response at the end of the study
次要结局
- 1.Assessing additional therapeutic benefits of Orthoherb oil.(2.Reconsider the need of pharmaceutical modification of the product to increase patient compliance if required.)