CTRI/2024/05/066714尚未招募2/3 期
A single arm clinical study to evaluate the efficacy of duralabhadi leha in the management of tamakashwas in children.
Dr Pranjali Undre1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年5月13日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- To decrease breathing difficulty and cough in children
研究概览
简要总结
THIS IS SINGLE ARM CLINICAL STUDY IN WHICH THE MEDICINE DURALABHADI LEHA WILL BE PROVIDED TO 35 PATIENTS SHOWING SIGN AND SYMPTOMS OF TAMAKSHWAS.THE AGE GROUP TAKEN FOR THE STUDY TRIAL WILL BE IN BETWEEN 1 YEARS TO 12 YEARS.DURALABHADI LEHA WITH MADHU WILL BE GIVEN FOR 7 DAY / THRICE A DAY.DOSE WILL BE CALCULATED BY AGE FORMULA.FOLLOW UP WILL BE DONE ON 4TH AND 7TH DAY AND TOTAL DURATION OF CASE STUDY WILL BE 7 DAYS.THE FINAL CONCLUSION WILL BE DRAWN ON THE BASIS OF STATISTICAL METHODS.
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
- 1.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Children having symptoms of Tamaka Shwasa as mentioned by Charak : Shwasakruchhrata (Dyspnea) Kasa (Cough) Ghur-Ghurak Shabda (Wheezing) Kashten Shleshma Moksha (Difficulty in Expectorant) Peenas 2)Children of age Group 1 year to 12 years.
- •Children who has a family history of asthma with a symptoms of Tamaka Shwasa.
- •Chidren who are ready to participate in the clinical trial by giving informed written consent.
排除标准
- •Patients having life threatening illness and who are bed ridden.
- •Patients having any congenital respiratory and GIT abnormality.
- •Patients who require surgical management.
- •Patients with known case of Pulmonary Tuberculosis, Pleural effusion, Emphysema, Bronchial Carcinoma, Status asthmatics 5)Patients having other systemic major illness like Immunocompromise diseases, Cardiac Disease, Renal Failure.
- •Patient with severe Asthmatic condition who needs Emergency treatment.
结局指标
主要结局
To decrease breathing difficulty and cough in children
时间窗: 7 Days study with followup on 4th day and 7th day | (0,4,7 Days)
次要结局
- To study the Adverse effect of Duralabhadi(leha, if any)
研究者
Dr Pranjali Undre
DR. D.Y. PATIL COLLEGE OF AYURVED ,PIMPRI PUNE.
研究点 (1)
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