A randomized open labelled controlled clinical study to evaluate the efficacy of Amrutadi Kwatha in the management of Urdhwaga Amlapitta with special reference to Gastroesophageal reflux disease.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in symptoms of Urdhwaga Amlapitta with special reference to Gastroesophageal reflux disease based on subjective parameters is assessed.
研究概览
简要总结
·
Amlapitta is the disease of Annavaha and Rasavaha Srotas which is classified according to pravrutti into two categories; Urdhwaga and Adhoga Amlapitta*. Amlapitta* is one of the major diseases caused by lifestyle changes as its prevalence is increasing day by day.
Gastroesophageal reflux disease (GERD) is defined as retrograde flow of gastric contents into esophagus, characterised by heartburn, acid regurgitation.
Gastroesophageal reflux disease is one of the most common chronic disorders of the gastro intestinal system. The incidence of GERD is high in general population, it is estimated to affect up to 20% of the population worldwide. (2019)
The prevalence of GERD in India ranges from 7.6% to 30%, being < 10% in most population studies, and higher in cohort studies in 2019. The pooled prevalence of GERD in Indian population is 15.6% in 2021.
K 21.9 is the ICD-10-CM code used for diagnosing Gastroesophageal reflux disease.
EB-04 is the National Ayurveda morbidity code for Amlapitta.
Commonly used pharmacological contemporary medicines include Proton pump inhibitors like Omeprazole, Pantoprazole, Lansoprazole which can cause adverse effects like headache, diarrhoea, Antacids like Calcium carbonate, Aluminium hydroxide cause adverse effects like constipation, abdominal pain. (11) H2 receptor blockers like Ranitidine, Famotidine cause adverse effects like constipation, fatigue, headache.
Considering the prevalence, adverse effects and dependence on contemporary interventions, it is highly relevant to search for an effective formulation to manage Urdhwaga Amlapitta with special reference to Gastroesophageal reflux disease. Hence the study is opted.
Amrutadi Kwatha mentioned in Vangasena Samhita under the context of Amlapitta Adhikara consists of Guduchi, Nagara, Musta, Kiratatikta.These ingredients are attributed with Tridosha hara, Deepana, Pachana property. Hence, considering the above background, it was thought worthy to evaluate the efficacy of oral administration of Amrutadi Kwatha in Urdhwaga Amlapitta with special reference to Gastroesophageal reflux disease.
Simhasyaadi Kwatha mentioned in Cakradatta under the context of Amlapitta Adhikara, consists of Vasa, Guduchi, Brihati. Simhasyaadi Kwatha being a proven drug for Amlapitta, is taken as the control drug for the present study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects of either gender between age of 21-60 years.
- •Subjects freshly diagnosed with Urdhwaga Amlapitta (Gastroesophageal reflux disease) who are not on any interventions presenting the cardinal symptoms.
- •Tikta amlodgara, Kantadaha, Hritdaha with or without associated symptoms like Klama, Gaurava, Avipaka, Aruchi, Chardi, Utklesha, Shiroruja.
- •Subjects who are willing to give informed written consent.
排除标准
- •Subjects diagnosed with Gastroesophageal reflux disease caused due to any other secondary conditions.
- •Subjects with diagnosed cases of erosive and post operative Gastroesophageal reflux disease.
- •Subjects suffering from any uncontrolled systemic disorders which will interfere with the course of disease and course of treatment.
- •Pregnant and Lactating women.
结局指标
主要结局
Changes in symptoms of Urdhwaga Amlapitta with special reference to Gastroesophageal reflux disease based on subjective parameters is assessed.
时间窗: 0th day - Before intervention | 15th day - During intervention | 30th day - After intervention | 45th day - Drug free follow up
次要结局
- Generation of in depth analyzed data on the different aspects of the disease(0th day - Before intervention)
研究者
Dr Savinaya K
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore