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临床试验/CTRI/2024/07/071548
CTRI/2024/07/071548尚未招募不适用

Cross-over study to assess the importance of Go-Ksheera as Nitya Sevaniya Dravya on Gut Health

Dr Tarini Venkatanarayan1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Appropriate assessment of the effect of regular consumption of go ksheera on gut health.

研究概览

简要总结

Gut health is a state of physical and mental well-being in the absence of - Gastrointestinal complaints that require the consultation of a doctor, indications or risks for bowel disease and absence of confirmed bowel disease.

It is impacted by various factors, but mainly by food articles consumed on a regular basis.

Dairy and its products in a normal Indian diet constitute around 15% and 19% in Rural and Urban population respectively. Making it a factor that could influence the gut health of an individual.

Milk is often called nature’s complete food because of being an ideal source containing most nutrients essential to human growth, sustenance and development.

The classics of Ayurveda have mentioned Ksheera as a part of the Nitya Sevaniya Dravyas and as an Ajasrika Rasyana.

Consumption of milk has become a subject of debate due to the various symptoms that arise due to lack of proper digestion of milk and the impact of it on the gut or GI Tract.

Thereby, depriving many from getting the potential benefits of regular milk intake.

Any disturbance in gut health can create unpleasant sensations - a state that is subjective and interferes with daily activities of individuals. Good gut health is closely linked to overall well-being and better immunity.

Hence, this study aims to understand the role of daily consumption of go-ksheera  in healthy individuals, focusing on the effects it has on gut health.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Subject recruitment after assessing Arogya Linga
  • Subjects consuming A2 cow milk without additives that contain caffeine 3.Subjects with self reported milk intolerance will be considered.
  • Subjects willing to give written consent and willing to participate in the study.

排除标准

  • 1.Subjects suffering from any systemic disease.
  • cardiovascular or metabolic diseases and under medication for the same. 2.Pregnant and lactating women 3.Subjects with participation in similar interventions of dairy or probiotic-containing product within 3 months before screening. 4.Subjects diagnosed with any gastrointestinal disorders or gastrointestinal disease, such as irritable bowel syndrome, colitis, ulcerative colitis, and celiac disease. 5.Current habitual alcohol intake and/or smoking. 6.Subjects not willing to participate in the study.

结局指标

主要结局

Appropriate assessment of the effect of regular consumption of go ksheera on gut health.

时间窗: Pre-Study Assessment - 0th Day | (1st Assessment) | 2nd Assessment - 7th Day (after 7 days wash off for regular milk consumers, for consumers who do not have milk regularly - after minimum 5 out of 7 days of milk consumption) | 3rd Assessment - 14th Day (after 7 days of recommended milk consumption pattern based on previous assessment)

Creation and validation of a gut health questionnaire.

时间窗: Pre-Study Assessment - 0th Day | (1st Assessment) | 2nd Assessment - 7th Day (after 7 days wash off for regular milk consumers, for consumers who do not have milk regularly - after minimum 5 out of 7 days of milk consumption) | 3rd Assessment - 14th Day (after 7 days of recommended milk consumption pattern based on previous assessment)

次要结局

  • Observing and analysing the effects of abstinence of milk in healthy individuals.(Pre-Study Assessment - 0th Day)

研究者

发起方
Dr Tarini Venkatanarayan
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Tarini Venkatanarayan

Sri Sri College of Ayurvedic Science and Research, Bengaluru

研究点 (1)

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