An open label, clinical study to evaluate the safety and efficacy of Zandu Kesri Jivan to improve immunity, strength, stamina and energy.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Zandu Kesri Jivan will be assessed in terms increase of subject immunity. Symptoms associated with general debility , Pathological Examination value
研究概览
简要总结
Zandu Keshri Jivan îs an Ayurvedic proprietary product being marketed in India from more than five decades. Enriched with properties of chyawanprash, a well-known Rasayana, Ramayana is well known for maintaining physical and mental health, provide strength & stamina, helps in delaying the ageing process. Zandu kesari Jivan is developed to maintain health of elderly people. It helps to improve appetite, digestion, provides strength, and enhances immunity and cognitive function.
Zandu kesari jivan contains ingredients Amalaki, Ashwangandha, Bala, Gokshur, Swet Musali, Jatiphal, Lavang,Marich, Pippali, Twak, Vanshlochan, Sunthi, Vidang and kesar. It also contains minerals like Yashad bhasma, Abharak Bhasma and Mukta Sukti Bhasma. These ingredients are helpful in providing strength, stamina, reduces stress and anxiety, improves digestion as well as cognitive function, supports bone and joint health and improves quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 45.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who meet all of the following criteria will be included in the study: 1) Age: 45 to 75 years (both inclusive) at the time of consent.
- •Sex: male and/or female.
- •Subject with physical weakness (Daurbalya), frequent illness (cold (Pratishyaya) and cough (Kasa)), fatigue (Thakan), poor cognitive health (Smriti daurbalya), poor digestive health (Ajirna) 4) Subjects should be willing and able to follow the study protocol to participate in the study.
- •Subject must be able to understand and provide written informed consent to participate in the study.
排除标准
- •Subjects who meet any of the following criteria will be excluded in the study: 1) Subject with known sensitivity or contraindication to any of the ingredients of study medication 2) Presence of any chronic disease or illness in the past three months or any clinically significant on-going chronic medical illness e.g. Congestive cardiac failure, Hepatitis, Hypotensive episodes, etc.
- •Recent history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to the study.
- •Participation in any similar clinical trial within the past 90 days with blood loss more than 450 mL.
- •An unusual diet, special diet, for whatever reason e.g. high protein diet, low sodium diet, for two weeks prior to receiving any test food and throughout subject’s participation in the study.
- •Pregnant or lactating females.
- •History of Hepatitis B or C virus.
- •Physician decision that involvement in the study is not in the subject´s best interest.
结局指标
主要结局
Zandu Kesri Jivan will be assessed in terms increase of subject immunity. Symptoms associated with general debility , Pathological Examination value
时间窗: Study duration - 60 days, A total of 60 adult, male and/or female subjects will be enrolled in the study, in order to get at least 50 evaluable subjects at the end of the study. Adult, male and/or female subjects between the ages of 45 to 75 years old (both inclusive) at the time of consent.
次要结局
- 50 subjects of either sex will be enrolled from screening passed subjects.(Zandu Kesri Jivan (ZKJ) (approximately 12 g) will be given orally two times a day approximately 12 hours (±1 hours) for 60 days to recruited subjects.)
研究者
Dr Sandeep Sharma
Jindal Super Specility Hospital