An interventional prospective study to ascertain the effectiveness of individualized dynamized homoeopathic medicine in cases of primary hypertension in adults using American Heart Association classification
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in systolic and diastolic blood pressure, categorised according to American Heart Association stages before and after treatment, measured using sphygmomanometer
研究概览
简要总结
HYPERTENSION IS KNOWN AS "SILENT KILLER" AND CHRONIC PROGRESSIVE CONDITION AND ONE OF THE LEADING CAUSES OF ALL POSSIBLE DISEASES. IN MODERN LIFESTYLE DUE TO VARIOUS CAUSES SUCH AS NEW LIFESTYLE ADAPTATIONS, INTAKE OF FAST FOOD, HIGH SOCIETY AND SO ON. MODERN CONVENTIONAL TRATM- RELIES ON LONG TERM ANTIHYPERTENSIVE DRUGS, WHICH MAY CAUSES MANY SIDE EFFECTS.
THIS PROSPECTIVE, INTERVENTIONAL, SINGLE ARM, OPEN LABEL CLINICAL STUDY AIMS TO EVALUATE THE EFFECT OF INDIVIDUALIZED DYNAMIZED HOMOEOPATHIC MEDICINE IN ADULTS AGED 30-60 YEARS DIAGNOSED WITH PRIMARY HYPERTENSION, CLASSIFIED AS PER AMERICAN HEART ASSOCIATION. 50 PATIENTS FULFILLING THE INCLUSION CRITERIA WILL BE RECRUITED THROUGH SIMPLE RANDOM SAMPLING. EACH PARTICIPANT WILL RECEIVE INDIVIDUALIZED DYNAMIZED HOMOEOPATHIC MEDICINE FOR 9-12 MONTHS. OUTCOMES WILL BE ASSESSED USING BLOOD PRESSURE READINGS AND SF- 36 HEALTH SURVEY TO MEASURE QUALITY OF LIFE. THE STUDY AIMS TO GENERATE EVIDENCE ON HOMOEOPATHY AS A POTENTIAL COMPLEMENTARY APPROACH FOR BETTER HYPERTENSION CONTROL AND IMPROVED PATIENT WELL- BEING
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed with primary hypertension.
- •Patient willingness to provide informed consent.
- •Age group in between 30-60 years.
- •Not involved in another clinical trials.
排除标准
- •Individuals with secondary hypertension due to other medical conditions (e g.- kidney diseases, thyroid disorders, diabetes).
- •Individuals below 30 and above 60 years of age.
- •Individual having mental disorders.
- •Woman- pregnant or continue breastfeeding Withdrawal cases and drop out cases- not taking medicines at proper time, no further follow-ups.
结局指标
主要结局
Change in systolic and diastolic blood pressure, categorised according to American Heart Association stages before and after treatment, measured using sphygmomanometer
时间窗: 15 days, 1st month, 2nd month and 3rd month
次要结局
- Changes in quality of life(15 days, 1st month, 2nd month & 3rd month)
研究者
Parekh Palak Hetankumar
Rajkot Homoeopathic Medical College