A Randomized, Multicentric,Open label,Interventional study to evaluate the Efficacy and Tolerability of four types of AMRUTANJAN PAIN BALM for pain relief in patients with primary type of HEADACHE and BODY PAIN disorders.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- To assess the onset of pain reduction after treatment at 30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min.(using visual analog scale)
研究概览
简要总结
We will screen and enroll 144 study participants with knee pain, lowback pain and primary headache disorders as per the inclusion criteria.**Each arm will comprise 12 studyparticipants with knee pain, 12 study participants with low back pain and 12study participants with primary head ache disorders.**The study participants will berequested to apply pea-sized amount of approximately 0.25g of the pain balm inthin layer to the pain area. In case of roll-on, gently apply 4rolls (equivalent to 0.25g) on the pain area as mentioned above. The primary efficacyend points are: 1.To assess the onset of pain reduction after treatment at 30 seconds,1 min, 2 min, 5 min, 10 min, 30 min and 60 min. (using visual analog scale) and To assess the durationof action (i.e. monitor the need for second application) of the test productfor pain relief.(time frame : 0-24 hours)
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 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 body pain disorders like knee pain, low back pain and primary type of headache disorders like migraine, tension type headache and other primary head ache disorders.
排除标准
- •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.Secondary type of headache disorders.
- •3.Known allergy to compounds of investigational product.
- •4.Subjects who had a diagnosis of basilar or hemiplegic migraine.
- •5.Patients suffering from medical or psychiatric conditions that would increase the risk of adverse events or interfere with study assessments.
- •6.Participation in an investigational drug trial in the 30 days prior to the screening visit.
- •7.Immuno-compromised (history) individuals like known HIV positive patients or patients who are on treatment with steroids or immunomodulators.
- •8.Patients of vulnerable group (children, lactating mother, elderly >80 years, handicapped, seriously ill, mentally challenged).
- •9.History of drug or alcohol abuse during the last 6 months.
结局指标
主要结局
To assess the onset of pain reduction after treatment at 30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min.(using visual analog scale)
时间窗: 30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min
To assess the duration of action (i.e need for second application) of the test product for pain relief.(time frame : 0-24 hours)
时间窗: 30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min
次要结局
- To monitor other complications like skin rashes, redness, photophobia, and phonophobia.(0-24 hours)