Randomized open labeled controlled clinical trial of Kshavakadi taila nasya and Brihad dadimashatak churna in kaphaj pratishyaya with special refernce to allergic rhinitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- efficacy of trial drug on allergic rhinitis on assessment criteria- Excellent/ Moderate Improvement / Mild Improvement / Ineffective
研究概览
简要总结
Null Hypothesis
There is no role of Kshavakadi taila nasya 4-8 drops OD of 2 settings with 7 days interval and Brihad dadimashatak churna 3gm BD for 30 days in the management of Kaphaj Pratishyaya with special reference to Allergic rhinitis.
Alternative Hypothesis H1
There is significant effect of Kshavakadi taila nasya 4-8 drops OD of 2 settings with 7 days interval and Brihad dadimashatak churna 3gm BD for 30 days in Kaphaj Pratishyaya with special reference to Allergic rhinitis.
Alternative Hypothesis H2
Kshavakadi taila nasya 4-8 drops OD of 2 settings with 7 days interval and Brihad dadimashatak churna 3gm BD for 30 days have better effect than Anu taila nasya 4-8 drops OD of 2 settings with 7 days interval and Vyoshadi vati 250mg BD for 30 days in Kaphaj Pratishyaya with special reference to Allergic rhinitis.
Selected 150 patients will be randomly distributed into two equal groups each comprising 75 patients.
Group will be named as Group A and Group B.
Group A will be trial group.
Group B will be control group.
Trial group (Group A)
Randomly selected 75 patients will be treated with Kshavakadi taila nasya and
Brihad dadimashatk churna
Nasya Dose - 4-8 drops OD for 7 days (2 settings with 7 days interval) Time – at morning
Brihad dadimashatk churna – 3gm BD for 30 days.
- Control group (Group B)
Randomly selected 75 patients will be treated with Anu taila nasya and Vyoshadi Vati.
Nasya Dose -4-8 drops OD for 7 days (2 settings with 7 days interval) Time – at morning
Vyoshadi Vati – 2 BD (250mg each)
For 30 days
Each patient included in the study will be given treatment for 30 days.
Follow up on – 15th, 29th, 60th day of study.
Study will be carried out in 3 years duration of Ph.D. On each step data will be recorded. observation, discussion and conclusion are drawn from statastical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients selected as per diagnostic criteria who are suffering from Kaphaj Pratishyaya.
- •Patients who are willing for treatment.
- •Diagnostic criteria: 1) Nasasrava -Thin, watery, clear 2) Kshavathu – frequent sneezing 3) Shiro -gala-talu kandu 4) Shirogurutva 5) Recurrent attacks of cold with exposure to allergens.
排除标准
- •C) Exclusion criteria: Local: 1) Patients suffering from nasal benign and malignant tumor.
- •Patients suffering from epistaxis.
- •Patients suffering from vestibulitis, furuncle, severe D.N.S, nasal polyp.
- •Systemic: 1) Patients suffering from other systemic diseases like uncontrolled D.M., HTN.
- •Pregnant woman and lactating mother.
- •Patients suffering from autoimmune disorders.
- •Any other acute infection / febrile illness.
结局指标
主要结局
efficacy of trial drug on allergic rhinitis on assessment criteria- Excellent/ Moderate Improvement / Mild Improvement / Ineffective
时间窗: 60 days
次要结局
- To compare the efficacy of Kshavakadi taila nasya & Brihad dadimashatk churna with Anu taila nasya & Vyoshadi vati in the management of Kaphaj Pratishyaya with special reference to allergic rhinitis.
研究者
Dr Puja Sharadchandra Pandit
YCAMC And Hospital, Aurangabad, Maharashtra