Clinical Evaluation of Turmeric and Tulsi Polyherbal Formulation in the Management of Frailty in Elderly Population: An Open Label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Frailty Score
研究概览
简要总结
The aim of this study is to determine the efficacy of turmeric and tulsi polyherbal formulation in the management of frailty in the elderly population.
详细描述
Frailty is a wasting syndrome of old age that leaves a person vulnerable to falls, functional decline, morbidity and mortality. Reducing the severity of frailty will provide large benefits for individuals, their families and for the society. It is assumed that early intervention with frail people will improve quality of life and reduce the costs of care. This trial is testing the frailty intervention with herbal medicine. If this frailty intervention is shown to be effective, there are major potential benefits to the frail older population generally in terms of decreased disability. The interventions being examined are readily transferable to routine clinical practice and can potentially be applied routinely in aged care services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open label study
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects above the age of 65 years, providing written informed consent.
- •Meeting three or more Cardiovascular health study frailty criteria
- •Mild or no cognitive impairment (defined as a Mini-Mental State Examination score >23),
- •Able to walk without personal assistance and no other physical limitations that can limit participation and adherence, particularly to exercise intervention program
排除标准
- •People will be ineligible to participate in the trial if they:
- •Live in a residential aged care facility
- •Severe audio-visual impairment
- •Progressive, degenerative neurologic disease like Parkinsonism, fits/ epilepsy, etc.
- •Rapidly progressive or terminal illness under palliative care with life expectancy less than 12 months
- •History of alcohol abuse or any other substance abuse
- •Severely affect muscle/joint dysfunction resulting in disability
- •Hospital admission in the past 3 months
- •Regular physical training or physiotherapy or current participation in a vigorous exercise or weight-training program more than once per week
- •Undergoing therapeutic diet incompatible with nutritional supplementation
- •In the opinion of research clinician, the intervention is deemed to be potentially hazardous for the subject, such as serious cardiac and pulmonary disease.
研究组 & 干预措施
Intervention Group
Participants will receive turmeric and tulsi capsule with milk(100 ml) along with standard of care treatment as determined by research physician...Each participants has to take two capsules of turmeric formula and tulsi twice daily for the study period of 3 months
干预措施: C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk (Drug)
Intervention Group
Participants will receive turmeric and tulsi capsule with milk(100 ml) along with standard of care treatment as determined by research physician...Each participants has to take two capsules of turmeric formula and tulsi twice daily for the study period of 3 months
干预措施: Standard of Care (Other)
Standard Care Group
Participants will only receive the standard of care treatment as determined by research physician
干预措施: Standard of Care (Other)
结局指标
主要结局
Frailty Score
时间窗: 3 months
To assess a change in frailty score from baseline in 3 months between two groups
次要结局
- Mortality(3 months)
- Health service utilization(3 months)
- C reactive protein(3 months)
- Frequency of falls(3 months)