EVALUATION OF SAFETY AND EFFICACY OF A POLY HERBAL FORMULATION ADATHODAI CHOORANAM IN IYA ERAIPPU NOI(BRONCHIAL ASTHMA)

AYOTHIDOSS PANDITHAR HOSPITAL1 个研究点分布在 1 个国家目标入组 125 人开始时间: 2013年12月15日最近更新: 2013年12月19日

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 125
试验地点: 1
主要终点: Moderate response

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

It is a single, non-randomized, open-label trial to determine the efficacy and safety of ADATHODAI CHOORANAM in patients with IYA ERAIPPU NOI (BRONCHIAL ASTHMA). The trial drug Adathodai Chooranam is a herbal formulation taken from the classical Siddha text Book â€˜Sigitcha Rathna Deepam Enum Vaidhya Noolâ€™ Page No.118 & 119 which is a approved text Book of Drug and Cosmetics Act 1940.In this trial 125 Bronchial asthma patients will be recruited and the trial drug will be administered 1.5 gm twice a day along with milk for a period of 30 days. During this trial period all the study related data will be recorded and documented in a separate trial master file for each patients.During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee OF NIS. During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically .The out come of this trial will be published in Indian Journal of Medical Research.

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: 15.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•1.Patients who are having classical symptoms of Bronchial Asthma that difficulty in breathing, Tightness of Chest, Wheezing, Dry (or) Productive Cough, 2.Only new patients will be included.
•3.Aged between 15 to 60 years of both sexes.
•4.Willing to give blood specimen, sputum, Radiological Investigation and Willing to be admitted in the hospital (or) attend the OPD once a week for 3 weeks.
•5.Patients who are willing to estimate volume of air forcibly expired after a deep inspiration by using peak flow meter.

排除标准

•1.Pregnancy and Lactation period.
•2.Significant Systemic illness including Cardiac Diseases, Renal Diseases, Hypertension.
•3.Patients with only nasal block or rhinorrhoea.
•4.Other respiratory Diseases such as Tuberculosis, Pneumonia, COPD,Bronchiectasis, cystic fibroisis, 5.Endocrine Disorders like Hypo & Hyper Thyroidism, Diabetes Mellitus 6.Status Asthmaticus.