跳至主要内容
临床试验/CTRI/2020/12/029595
CTRI/2020/12/029595已完成2/3 期

A study to evaluate the effectiveness of Ashwagandhadi granules on physical performance in healthy individuals

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年12月16日最近更新:
适应症

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Improvement of physical performance in apparently healthy individuals

研究概览

简要总结

Physicalfitness is a state of health and wellbeing and more specifically the ability toperform aspects of sports, occupation and daily activities. Physical fitness isgenerally achieved through proper nutrition, moderate physical exercise,hygiene and sufficient rest. Among these the important modifiable factors areexercise and nutrition. Considering the nutritional aspect of physical fitness,supplements are required to bridge the gap due to faulty food habits. But inthe present scenario the supplements available in the market are not meetingthe required standards and many are not scientifically researched for itsnutrient content. Hence there is a need for a health supplement which meets thedaily requirements which is tasty health promotive and provide optimumnutrients for improving the physical fitness. Ashwagandha, Shatavari,Ragi,Mudga, Jeeraka and shunti are formulated in granules and is evaluated for itseffectiveness in physical performance in healthy individuals.

Thisstudy is a comparative clinical trial where the healthy volunteers are observedfor one month and the next month they will be administered with Ashwagandhadigranules for one month and then assessed for their physical performance.

This is an open labelled wait listed cross over to study the effectiveness of Ashwagandhadi granules on physical performance in apparently healthy individuals The subjects reporting at the Out Patient Department of Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan will be allocated to control group of 20 subjects and after a period of one month of observation they will be shifted to study group and will be administered with 20 gms of Ashwagandhadi granules with 150 ml of milk 

Control group: 20 subjects included in study for a period of one month and data will be collected before and after the study. The same subjects will then be shifted to study group.

Study group: 20 grams of Ashwagandhadi Granules with 150 ml of milk twice daily after food for 20 subjects included in study for a period of one month and data will be collected before and after the study.

Conclusion- Ashwagandhadi granules increase the  physical performance

研究设计

研究类型
Interventional
分配方式
Other
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • •1 Subjects of the age group of 18- 40 years irrespective of gender will be selected 2 Subjects who are not on any other dietary supplements 3 Apparently healthy subjects who are ready to sign the consent form and are interested and willing to take Ashwagandhadi Granules.

排除标准

  • •Pregnant women lactating women.

结局指标

主要结局

Improvement of physical performance in apparently healthy individuals

时间窗: 18 months

次要结局

  • Improve the quality of life(18 months)

研究者

发起方
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan
申办方类型
Private medical college

研究点 (1)

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