A Comparative Phase 2 clinical study to evaluate efficacy of Kantakaryadi Kwatha and Bhunimbadi Kwatha in Urdhavag Amlapitta
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction of acid reflux
研究概览
简要总结
In modern era amlapitta is a most remarkable problem in the society it is a very common disease mostly affecting the adult men and women in the Indian population As the treatment the use of antacids which has symptomatic relief only Antacids that contain aluminum hydroxide may causeconstipationaluminum intoxication osteomalacia and hypophosphatemia Kantakaryadi kwatha is a drug of choice for Amlapitta contain all the necessary ingredients that are useful to breakdown pathophysiology of Amlapitta by their rasa and virya properties Kantakaryadi kwatha will be preparaed as per reference mentioned in ayurvedic text under supervision of experts in Dept. Of Rasashastra & Bhaishajyakalpana of Ayurved Seva Sangh College Nashik and Bhunumbadi Kwatha is a drug of choice for parallel study It is prepared by a GMP certified Ayurvedic drug manufacturing company The clinical study to evaluate the efficacy of these drugs will be beneficial to the practitioners of Ayurveda throughtout the world so here study is designed to evaluate the efficacy of Kantakaryadi Kwatha internally twice a daily for 21 days and Bhunimbadi Kwatha internally twice a daily for 21 days in the management of Amlapitta
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Obesity induce hyperacidity Patients fulfilling the diagnostic criteria which are based on sign and symptoms of amlapitta.
排除标准
- •Patient not willing for clinical trial Pregnant and lactating mothers Patients suffering from any other chronic systemic disorders stomach abnormality like hiatus hernia Connective tissue disorders such as scleroderma Taking other medicine like aspirin ibuprofen Non steroidal anti inflammatory drugs High blood pressure medicine Iron supplements tricyclic antidepressants Anti-anxiety drugs etc.
结局指标
主要结局
Reduction of acid reflux
时间窗: 21 days
次要结局
- Reduction of associate symptoms related to acidity(21 days)
