CTRI/2022/11/047469尚未招募Unknown
An open label, non comparative and prospective clinical trial on the efficacy of Bal-Rasayana®syrup in children suffering from Allergic Rhinitis
Gurukrupas Amruta Ayurveda LLP1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月12日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Reduction in episodes of allergic rhinitis
研究概览
简要总结
An open label, non comparative and prospective trial will be conducted to evaluate the efficacy of Bal-Rasayana syrup in the management of allergic rhinitis in children. Children with predominant symptoms of allergic rhinits between the age group of 3 to 16 years will be selected clinically from OPD. Drug will be given as per dose explained in classics in morning and evening before snacks. Duration of trial will be of 90 days. treatment start - Day 0. Follow up on 30th, 60th and 90th day. Patient will be reviewed on 120th day. Primary end point - 90th day and secondary end point - 120th 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
- 3.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed as suffering from Vataja Pratishyaya on Ayurvedic parameters (allergic rhinitis)
- •Age group of 3 to 16 years
- •Cardinal features of allergic rhinitis
- •History of at least 3 episodes in last six months.
排除标准
- •Individuals below 3 years and above 16 years
- •Severe and Complicated respiratory allergic disorders like Bronchitis, Pneumonia, Tuberculosis, Emphysema, Lung abscess, bronchieactasis
- •Patients who are diagnosed as asthma
- •Nasal polyposis
- •Congenital anomalies related to respiratory system
- •Patients on inhaled or systemic steroids
- •Patients who are suspected of any of the diseases mentioned in exclusion criteria on the basis of history and examination will be excluded.
结局指标
主要结局
1. Reduction in episodes of allergic rhinitis
时间窗: 30, 60 and 90 days
2. Reduction in severity of allergic rhinitis
时间窗: 30, 60 and 90 days
次要结局
- 1. Improvement in Laboratory parameters(2. Improvement in morbidity specifically time to recovery, number of acute lower respiratory tract infections (ALRI) and hospitalizations during the treatment phase)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Faslodex in McCune-Albright SyndromePuberty, PrecociousMcCune-Albright SyndromeNCT00278915AstraZeneca30
已完成
不适用
A clinical trial to find the efficacy and safety of Tubby nutririch lotion for the treatment of dry skin in infants and children.CTRI/2012/08/002876Sante Mernaud Pharmaceuticals Pvt Ltd15
已完成
不适用
Evaluation of the Performance of a Fungal Nail Treatment on the Visual Signs of OnychomycosisOnychomycosis of ToenailsNCT02546258Reckitt Benckiser Healthcare (UK) Limited60
已完成
3 期
Efficacy and Safety of SmofKabiven Extra Nitrogen for Parenteral Nutrition in Patients Receiving Intensive CareNutrition TherapyCritical IllnessNCT05257031Fresenius Kabi56
已完成
不适用
A clinical trial to evaluate the safety and efficacy of HAIRAL 7 in hair regrowth and in the treatment of dandruff and hair loss in female and male patients.CTRI/2012/02/002461ABS LABORATORIES60