A single arm open label interventional study to evaluate the efficacy and tolerability of Amrutanjan pain balm extra power for pain relief in patients with primary type of headache disorders
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To assess the onset of pain reduction after treatment from
研究概览
简要总结
24 participants with primary type of headache disorders will be enrolled in this study in a single arm.Test Arm – Participants (24) with primary headache disorders will use Amrutanjan Pain balm extra Power twice or thrice daily topically for one day
Subjects will be asked to visit clinical facility/institution for their follow up visits on day 2. The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study.
24 participants will be randomized into a single group.
Test Arm – Participants (24) with primary headache disorders will use Amrutanjan Pain balm extra Power twice or thrice daily topically for one day
Subjects will be asked to visit clinical facility/institution for their follow up visits on day 2.
The primary outcome measures to study the efficacy are as follows:
To assess the onset of pain reduction after treatment from 30 seconds up to 15 minutes continuously
and then on hourly basis for 24 hours. (using visual analog scale)
To assess the duration of action/ pain relief (i.e. need for second application) of the test product for
pain relief. (time frame : 0-24 hours)
Visual analog scale (VAS) questionnaires will be filled in by the patients and scores given, ranging
from 0 to 10 (based on the severity of pain).
For statistical analysis, ordinal conversion of pain levels will be assigned as 0–no pain up to 10-
severe pain.
To monitor other complications like nausea, vomiting, photophobia, and phonophobia.
To monitor for any adverse events during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex aged above 18 years.
- •Patients who can 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.
- •Patients who had been diagnosed with primary type of headache disorders like migraine, tension type headache and other primary head ache disorders.
排除标准
- •Women of childbearing 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.
- •Secondary type of headache disorders.
- •Known allergy to compounds of investigational product.
- •Subjects who had a diagnosis of basilar or hemiplegic migraine.
- •Patients suffering from medical or psychiatric conditions that would increase the risk of adverse events or interfere with study assessments.
- •Participation in an investigational drug trial in the 30 days prior to the screening visit.
- •Immuno-compromised (history) individuals like known HIV positive patients or patients who are on treatment with steroids or immunomodulators.
- •Patients of vulnerable group (children, lactating mother, elderly greater than 80 years, handicapped, seriously ill, mentally challenged).
- •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 from
时间窗: 30 seconds up to 15 minutes continuously and then on hourly | basis for 24 hours
30 seconds up to 15 minutes continuously and then on hourly
时间窗: 30 seconds up to 15 minutes continuously and then on hourly | basis for 24 hours
basis for 24 hours using visual analog scale
时间窗: 30 seconds up to 15 minutes continuously and then on hourly | basis for 24 hours
To assess the duration of action ie need for second
时间窗: 30 seconds up to 15 minutes continuously and then on hourly | basis for 24 hours
application of the test product for pain relief time frame
时间窗: 30 seconds up to 15 minutes continuously and then on hourly | basis for 24 hours
0-24 hours
时间窗: 30 seconds up to 15 minutes continuously and then on hourly | basis for 24 hours
the severity of pain
时间窗: 30 seconds up to 15 minutes continuously and then on hourly | basis for 24 hours
For statistical analysis ordinal conversion of pain levels will
时间窗: 30 seconds up to 15 minutes continuously and then on hourly | basis for 24 hours
be assigned as 0 no pain up to 10-severe pain.
时间窗: 30 seconds up to 15 minutes continuously and then on hourly | basis for 24 hours
次要结局
- To monitor other complications like nausea, vomiting,(photophobia, and phonophobia.)
研究者
Dr Anand Babu MBBS
Shree Lakshmi Clinic