A Randomized, Multicentric,Open label,Interventional study to evaluate the Efficacy and tolerability of two 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
- 2/3 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- 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)
研究概览
简要总结
The selectedstudy participants will receive treatment as follows.
Test arm 1:Amrutanjan Pain Balm Extra Power (APBEP): 36 subjects
Test arm 2:Amrutanjan Strong Pain Balm Double Power (ASPBDP): 36 subjects
Eacharm will comprise 12 study participants with knee pain, 12 study participantswith low back pain and 12 study participants with primary head ache disorders.
The study participants will be requested to applypea-sized amount of approximately 0.25gof the pain balm in thin layer to the pain area
If they have no relief after 2 h of product application,they will be permitted to use their own rescue Medication. The participant willbe requested to visit for only one follow up on the subsequent day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
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, known spinal disc herniation and osteoporosis.
- •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
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)
时间窗: 30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min.
The primary efficacy endpoints are:
时间窗: 30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min.
2. To assess the duration of action (i.e need for second application) of the test product for pain relief.
时间窗: 30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min.
次要结局
- To monitor for any adverse events during the study period and assess the quality of life(30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min.)