Clinical study to evaluate the effect of oral administration of Tulasi Arka on Pratishyaya (Rhinitis) in children
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in symptoms of Pratishyaya like Nasasrava, Kshvathu, Ghranoparodha,Jwara, Kasa etc
研究概览
简要总结
Pratishyaya is one of the Urdvajatrugatavikara ,vata and kapha are said to be the predominant doshas.The symptoms of Rhinitis shows resemblance with the lakshana of Pratishyaya explained in Ayurveda classics.Pratishyaya is one of the disease in which the inflammation of mucous membrane of the nose is observed.It is characterised by Nasasrava(running nose), Nasavrodha(nasal blockage), Kshvathu(sneezing), Shirashoola(headache), Gandha ajana(loss of smell)etc.
Rhinitis is the inflammation of the nasal mucous membrane. Rhinitis is the irritation and inflammation of the some internal areas of the nose. The inflammation results in the generation of excessive amount of mucous,commonly producing the runny nose as well as nasal congestion and post nasal drip.Rhinitis is caused by chronic and acute inflammation of mucous membrane of the nose due to viruses,bacteria,allergens. Rhinitis describes a group of symptoms including rhinorrhea,itching and sneezing that are caused by irritation and congestion in the nose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 2.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between the age group of 2-6 years.
- •Children with Pratishyaya of recent onset within one week.
- •Children irrespective of gender, religion and socio-economic status fulfilling the diagnostic criteria.
排除标准
- •Congenital anomalies related to respiratory system.
- •Lower respiratory tract infection.
- •Jwara(>100oF)
- •Dushtapratishyaya, Raktapratishyaya and Sannipatajapratishyaya.
- •Chronic rhinitis, Sinusitis, Asthma, Infectious diseases like T.B. and other systemic disorders which interfere during the course of treatment.
结局指标
主要结局
Reduction in symptoms of Pratishyaya like Nasasrava, Kshvathu, Ghranoparodha,Jwara, Kasa etc
时间窗: Tulasi Arka orally administrated for 7 days & Response of drug compound will be assessed on 0, 4th & 8th day. Follow up assessment will be done on 14th day.
次要结局
- Patient well being,symptoms of Pratishyaya are reduced.(Tulasi Arka orally administrated for 7 days & Response of drug compound will be assessed on 0, 4th & 8th day. Follow up assessment will be done on 14th day.)