Efficacy of Individualized Homoeopathic Medicines In The Treatment Of Stage-I Essential Hypertension In Adults : A Double Blind, Randomized, Placebo_ Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To detect the group difference between individualized homoeopathic medicines and identical looking placebo in
研究概览
简要总结
This study is a double blind, randomized , placebo-controlled clinical trial designed to evaluate the efficacy of individualized homoeopathic medicines (IHMs) in the treatment of stage-I essential hypertension in adults. Hypertension is a leading non- communicable disease globally and a major risk factor for cardiovascular morbidity and mortality. This trial aims to compare changes in systolic and diastolic blood pressure over a 3 month period between two groups - one receiving individualized homoeopathic medicines and the other receiving identical looking placebo, measure the systolic and diastolic blood pressure in every 15 days up to 3 months. Secondary outcome include changes in biochemical parameters (lipid profile, liver and kidney function test, serum TSH, fasting and post prandial blood sugar) and health related quality of life measured by MYMOP-2 after 3 months of intervention.
The study duration is 1 year 6 months, with a total of 120 patients enrolled using 2:1 randomization ( 80 in IHMs group and 40 in placebo-controlled group), patients will be followed up every 2 weeks up to 3 month.
This study will be conducted in Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, utilizing its outpatient population. The findings aim to contribute to evidence-based validation of individualized homoeopathic intervention in managing stage I hypertension and improving patients quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Systolic Blood Pressure from (140-159) mm of Hg and Diastolic Blood Pressure from (90-99) mm of Hg.
- •Patients who have not taken any anti-hypertensive treatment.
- •3.Patient who can give their informed consent willingly for study and comply for regular follow up.
排除标准
- •Patient who had suffeing from secondary hypertension .
- •2.Patients suffering from any terminal illness like uncontrolled diabetes mellitus, chronic kidney disease, diagnosed autoimmune gastritis with hyperhomocysteinaemia, who have known heart disease like history of MI, coronary artery disease, history of cardio- vascular accident etc.
- •3.Pregnant women and lactating mother and 4.Person who had history of drug/alcohol abuse.
结局指标
主要结局
To detect the group difference between individualized homoeopathic medicines and identical looking placebo in
时间窗: After 3 months of intervention
systolic blood pressure (SBP) and diastolic blood pressure (DBP) in essential hypertension
时间窗: After 3 months of intervention
stage-I.
时间窗: After 3 months of intervention
次要结局
- 1.To detect the group differences of individuals becoming normotensive from stage-I essential hypertension.(2.To detect the group differences of biochemical parameters i.e., serum lipid profile, liver function test, serum urea and creatinine, serum TSH, serum FBS and PPBS.)
研究者
DR RESHMI KHATUN
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital