An Open Label Randomized Comparative Clinical Trial To Evaluate The Efficacy Of Shodhan Basti Over Isabgol Husk In The Management Of Mala Avruta Pakvasyagata Vata (Chronic Functional Constipation)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Shodhana Basti will show improvement in the symptoms of Mala Avruta vata assessed by “Bristol stool form scale†and Pureeshavruta vata assessment scale.
研究概览
简要总结
Constipation is a common gastrointestinal condition characterised by unsatisfactory defaecation as a result of infrequent stools, difficult stool passage, or both. The term functional constipation (FC) has been proposed and defined by the Rome Foundation to help standardise the diagnosis of chronic constipation in the absence of physiological abnormality.Contemporary laxatives, which are generally used in Constipation, become habitual after some duration and gives only symptomatic relief. Moreover, these medicines never alter pathogenesis of disease.The formulation used in this study i.e., Shodhana Basti is indicated for the treatment of Mala avruta Pakwashyagata vata. With this idea present study is planned to evaluate the effect of Shodhana Basti in Mala avruta Pakwasyagata vata.The study will be An Open Label Randomized Comparative clinical trial.In Control Group**patients will be advised to mix 5gm of Isabgol husk ( Plantago ovata )in 200 ml of lukewarm water, stir well, and consume immediately twice a day for 15 days. In Trial group participants will get Shodhana basti in the Kaala basti pattern for a period of 15 days. After that follow-up will be conducted on 30th ,45th and 60th day.The data will be statistically analysed by and will be presented in the form of dissertation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients meeting the “Rome III diagnostic criteria for functional constipation†2.Patients with a stool form score ranging from 1 to 3 on the “Bristol Stool Form Scale†3.Patient with the symptom of mala-avruta vata.
排除标准
- •Patients on chronic laxative medications.
结局指标
主要结局
Shodhana Basti will show improvement in the symptoms of Mala Avruta vata assessed by “Bristol stool form scale†and Pureeshavruta vata assessment scale.
时间窗: 1.5 yrs
次要结局
- Shodhana Basti will be more effective in the management of Mala Avruta vata than Isabgol(1.5 yrs)
研究者
Balyogeshwar Sharma
Shri Krishna AYUSH University
