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临床试验/CTRI/2023/05/052298
CTRI/2023/05/052298尚未招募3 期

Association between symptoms of Ama and Purisha characteristics features and evaluation of Chitrakadi tablet as Amapachana

Institute of Teaching and Research in Ayurveda Jamnagar1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年10月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Subsidence generalized defecation related symptoms of Ama

研究概览

简要总结

It is a Survey and clinical study to establish Association between symptoms of Ama and Purish characteristic features (if any) and evaluation of Chitrakadi tablet as Amapachana.

As per Ayurveda concept disease are having symptoms of Ama in initial stage, impact of Ama reflects on feces quality of the patients too. To observe these characteristics. Patient having at least three symptoms of Ama i.e., Udara Gaurava (heaviness in abdomen), Mala Sanga (retention of feces/constipation)), Apakti (indigestion) and age between 18 to 50 years.In this study total 100 patients will be registered.  After taking their inform consent recruited subjects will be analysed for presence of Ama and other examinations on the basis of prepared Performa. One day 0 the subject will be undergone for blood test Hb, CBC, ESR, FBS, Lipid profile, Renal function test and Urine routine and microscopic examination, stool microscopic examination. Further feces examination for its characteristics feature in context of Ama will also be assessed.

Out of surveyed patients who are willing to participate and abide to study protocol will be recruited for clinical trial. These patients will be given Chitrakadi tablet 2 tab. Twice a day after meal with luke warm water for 15 days. Patient will be assessed weekly for their impact in symptoms of Ama at the end of 15days, the patients will undergo for stool examination again (physical, microscopic & Jala Nimanjjan and other characteristics features of stool).Subjects will be assessed on the basis of especially prepared proforma incorporating demographic data, symptoms of Ama and details about Mala Parikshana. A closed ended questionnaire will be used to analyse Purishvaha Srotas dushti Lakshana and Sama Mala Lakshana. Written informed consent from subjects will be taken prior to registering them for the study

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
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Age between 18 to 50 years Patient having at least three symptoms of Ama i.e., Udara Gaurava (heaviness in abdomen), Mala Sanga (retention of feces/constipation)), Apakti (indigestion).
  • Willing to participate and abide to study protocol.

排除标准

  • Patient below 18 years and above 50 years of age.
  • Not willing to participate.
  • Patient who is already on ayurveda medication especially for Pachana Chronic debilitating disease like CA, DM, T.B, CKD.
  • Ulcerative colitis, peptic ulcer and haemorrhoids, cirrhosis of liver, portal hypertension.

结局指标

主要结局

Subsidence generalized defecation related symptoms of Ama

时间窗: day 0 and 16th day

次要结局

  • Absence of stickiness from feces(The stool remains float over water (Jala Santarana))

研究者

发起方
Institute of Teaching and Research in Ayurveda Jamnagar
申办方类型
Research institution and hospital

研究点 (1)

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