COLLABORATIVE MULTICENTRIC CLINICAL TRIAL TO STUDY THE EFFECT OF AYUSH RASAYANA (A&B)ON APPARENTLY HEALTHY ELDERLY SUBJECTS.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- 1.Any improvement in functional exercise capacity by 6 min. walk test
研究概览
简要总结
This is a research study being conducted as multicentric collaborative clinical research project sponsored by the Central Council for Research in Ayurvedic Sciences (CCRAS), Department of AYUSH, Ministry of Health & Family Welfare, Government of India, involving administration of Ayush Rasayana ‘A’ & ‘B’ with a view to scientifically document the clinical efficacy and safety of the said Ayurvedic formulations that have been in use since thousands of years for the promotion of general health, physical fitness and endurance.xml:namespace prefix = "o" /
The Rasayana drugs are said to have Anti-inflammatory, Anti-oxidant, Immuno-modulatory properties and have beneficial effects on cognitive functioning, physical fitness and endurance.
This study is a Open Label, clinical trial to see the effect of Ayurvedic Coded drugs (Ayush Rasayana A & B) on ageing in apparently healthy elderly subjects. The age group of the subjects selected for this study will be 60-75 years and they will be put on a trial for a period of 186 days (approx. 6 months)
Composition Of AYUSH Rasayana A:
5 grams of Ayush Rasayana ‘A’ contains 1.5 gm each of 3 herbs and 0.5 gm rock salt.
Composition of AYUSH Rasayana B:
750 mg of Ayush Rasayana ‘B’ contains 250 mg extract of 3 herbs each.
Acute, sub acute and chronic toxicity studies have been conducted with either of the trial drugs on mice and rats. The drugs were found safe experimentally.
PRIMARY OBJECTIVES
· To see the efficacy of Rasayana drugs in improving the general body health and quality of life in elderly people.SECONDARY OBJECTIVES
· To observe the changes in bio-chemical profile and other health parameters. · To see the safety of the Rasayana drugs as anti-ageing formulations."The Date of first enrolment is 22nd April 2015 actually. It was by mistake typed 20th February previously. The trial was registered on 8th April 2015. Since we have started enrolling the patients after the registration was complete officially, our trial is a prospective 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
- 60.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Apparently healthy volunteers •Willing to participate in the study Note : The subjects with grade-1 Hypertension and/ or Hb% up to minimum 11gm% may also be included in the study with careful data recording.
排除标准
- •â€¢Age< 60yrs or >75yrs •Participated in similar study previously or participating in any ongoing study • Hypertensives with BP>160/100mmHg •Subjects with HB<11gm% •Active/ chronic liver, kidney disease or Heart diseases •Severe disabled bedridden patients unable to go through the assessment •Psychiatric diseases • Diabetes with blood sugar more than 125mg % fasting and 200mg% PP •Any illness, according to PI, which is not conducive to the trial.
结局指标
主要结局
1.Any improvement in functional exercise capacity by 6 min. walk test
时间窗: 0 Day (Baseline) | 37th Day | 97th Day | 187th Day.
2.Any improvement in subjective QOL, using WHO QOL.
时间窗: 0 Day (Baseline) | 37th Day | 97th Day | 187th Day.
次要结局
- 1.Any improvement in cognitive functioning:HMSE scale.(2.Any change in pro-inflammatory marker: hsCRP (high sensitivity C-reactive protein))