to evaluate the efficacy Of Amlaki Churna in preventing hridya roga-Single Arm Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- To determine the efficacy of AMLAKI CHURNA in preventing HRIDYA ROGA
研究概览
简要总结
CARDIOVASCULAR DISEASEs are group of disorders of the heart and blood vessels and also include coronary heart disease, cerebrovascular disease, rheumatic heart disease and other conditions In classical literature rasadahtudushti is a major cause of heart diseases and rasadahtudushti is involved in pathophysiology of hridya roga.Some medicinal plants and food components (as monotherapy or adjunct to standard pharmacotherapy) have traditionally been used to treat CVD and have demonstrated various cardiovascular pharmacological effects.Emblica officinalis is one of the medicinal plants whose cardiovascular effects have been considered both in the traditional medicine and in the modern scientific literature. Hence based on the above review It is believed that amlaki churna possess properties that may help prevent heart disease, which is why we are conducting this study to investigate its potential effects on cardiovascular health. 3gm amlaki with lukewarm water given to patients initially for 20 days then after follow up drug will be given for next 20 days. 5. Follow up after 20 days for assessment.
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
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals of either sex aged 30-50 years irrespective of their occupation and socioeconomic status
- •Individuals having LDL more than 150mg/dl or  Total cholesterol more than 250mg/dl.
- •Willing and able to participate for 9 weeks
- •Individuals with informed consent 5.obese patient -BMI more than 25 6.pre hypertensive patient [BP more than 140/80 mmHg ]-not on medication 7.patient having complaint of headache 8.sedentary lifestyle 9.Individuals whose having rasadhatu dushti.
排除标准
- •Individuals who have received any medicines related to cardiac disorders(Modern Drug) within last 8 weeks.
- •Individuals having Type III and Type IV hypercholesterolaemia.
- •Individuals with poorly controlled Hypertension (more than 160 / 100 mm Hg).
- •Individuals with evidence of malignancy.
- •Individuals on prolonged (more than 6 weeks) medication with antidepressants, corticosteoids, anticholinergics, immunosuppressants, oral contraceptive pills or estrogen replacement therapy etc.
- •or any other drugs that may have an influence on the outcome of the study.
- •Individuals suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.).
- •Individuals who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •Symptomatic patient with clinical evidence of Heart failure.
- •Individuals with concurrent serious hepatic disorder (defined as aspartate aminotransferase (AST) and / or alanine aminotransferase (ALT), total bilirubin or alkaline phosphatase (ALP) more than 2 times upper normal limit) or renal disorders (defined as S.creatinine more than 1.2mg/dl), severe pulmonary dysfunction (uncontrolled asthma and chronic obstructive pulmonary disease [COPD]), inflammatory bowel disease or any other condition that may jeopardize the study.
- •Pregnant/ lactating females.
- •Individuals on oral contraceptives.
- •Alcoholics and/or drug abusers.
- •H/o hypersensitivity to any of the trial drugs or their ingredients.
- •Individuals who have completed participation in any other clinical trial during the past six (06) months.
- •Any other condition which the Principal Investigator thinks may jeopardize the study.
结局指标
主要结局
To determine the efficacy of AMLAKI CHURNA in preventing HRIDYA ROGA
时间窗: 60 days
次要结局
- Improvement in quality of life[SF-36](Improvement in assessment criteria[RAS-RCVD SCALE])
研究者
Dr Ragini Sharma
Chaudhary brahm prakash ayurveda charak sansthan,khera dabar,110073