Evaluating Homoeopathy as an Add-On Treatment to Standard Care in The Management of Resistant Hypertension and Cardiovascular Protection: A Randomized, Double Blind, Controlled, Exploratory, Feasibility Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate the changes in blood pressure (SBP/DBP) values over 6 months.
研究概览
简要总结
The prolonged condition of Resistant Hypertension can lead to adverse kidney outcomes, cardiac morbidity and other systemic changes, which points out the necessity for its treatment. This study shall evaluate the efficacy of Individualized Homoeopathic medicines as an add-on treatment to standard care in the management of Resistant Hypertension. It is a randomized, double blind, controlled, exploratory, feasibility trial and the Cardiovascular Protection is also assessed in the secondary outcome. The study shall be conducted at Sumandeep Vidyapeeth Deemed to be University, SVDU in collaboration with Central Council for Research in Homoeopathy, CCRH. Total one hundred participants shall be enrolled in this study, with 50 in each arm. The inclusion criteria include participants of both the gender, male and female, aged between 40-75years with known resistant hypertension condition and being adherent to its standard care. The adherence of the participants shall be assessed with Morisky Medication Adherence Scale, MMAS-8. Participants having controlled diabetes with HbA1c less than 7.5 - 8 percent and participants with mild and moderate chronic kidney disease i.e. stages G2-G3a (GFR between 45 to 90 mg/mmol) shall aso be considered into the study. Only the participants with voluntary written consent and ability to comply with the study protocol shall be enrolled. Participants in one arm shall be given Individualized homoeopathic medicine along with the standard care and in the other arm shall be given placebo along with the standard care. The primary objective is to determine the effectiveness of homoeopathy as an add-on treatment to standard care in the management of patients with resistant hypertension with changes in blood pressure (SBP/DBP) values over 6 months. Participants with co-morbidities shall be allowed to continue their previous medications prescribed by the conventional physician in the follow-up and can withdraw from the study at any time for any reason if they wish to do so without any consequences. This study shall be conducted according to the standards of Good Clinical Practice in India and in accordance with the requirements of the Declaration of Helsinki.
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
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Known case of resistant hypertension (Individuals having BP more than or equal to systolic 140mmHg and diastolic 90mmHg in those without diabetes mellitus or chronic kidney disease and more than or equal to systolic 130mmHg and diastolic 80mmHg in those with diabetes mellitus or chronic kidney disease despite the use of at least three antihypertensive drugs of different substance classes, including a diuretic at maximum tolerated doses) 2.Confirmation to the adherence to anti-hypertensive medication as assessed by Morisky Medication Adherence Scale-8(MMAS-8).
- •3.Participants aged between 40 to 75 years of age.
- •4.Both the genders.
- •5.Participants having controlled diabetes (HbA1c less than 7.5 to 8 percent).
- •6.Participants with mild and moderate chronic kidney disease, stages G2-G3a (GFR more than 45 to less than 90 mg per mmol) 7.Voluntary written informed consent.
- •8.Able to comply with the study protocol.
排除标准
- •Participants with history of stroke or transient ischemic attack or hypertensive encephalopathy or acute coronary syndrome or hospitalization for heart failure in the past 6 months.
- •Participants with known secondary hypertension.
- •Known participant of stage III and stage IV chronic heart failure.
- •Participants with chronic kidney disease (Stages G3b, G4, G5).
- •Participants who had undergone any major surgery in the past 6 months.
- •Pregnant ladies and breastfeeding mothers.
- •Participants with known mental ailments like schizophrenia and other psychotic conditions.
- •Participants with known systemic illness like cancer, HIV, genetic disorders etc.
- •Participants having any clinically relevant medical or surgical condition, that in the opinion of the investigator would put the person at risk by participating in the study.
结局指标
主要结局
To evaluate the changes in blood pressure (SBP/DBP) values over 6 months.
时间窗: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6.
次要结局
- To assess the changes in the quality of life using SF-36 questionnaire among the two groups at baseline and at month 6.(Baseline and Month 6.)
- To assess the compliance related to diet and physical activity using H-SCALE questionnaire among the two groups over the period of 6 months.(Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6.)
- To assess the changes in biochemical markers like blood glucose profile, lipid profile, liver function test, kidney function test, microalbumin, c-reactive protein at baseline and at month 6.
- To assess the changes in cardiac biomarker like cardiac troponin at baseline and at month 6.(Baseline and Month 6.)
- To assess the changes in ECG and CVD measures like baroreflex sensitivity (BRS) to quantify the influence of baroreflex on heart rate, HF-HRV to assess vagally mediated modulation of heart rate, FMD to evaluate endothelial function, PWD to assess arterial stiffness and LV mass to characterize left ventricular structure at baseline and at month 6.
- To assess the reduction of standard care drugs among the two groups over the period of 6 months.(Baseline and Month 6.)
- To assess the proportion of participant achieving goal approach of SBP/DBP less than 140/90 mmHg for those without diabetes mellitus or chronic kidney disease and less than 130/80mmHg for those with diabetes mellitus or chronic kidney disease at month 6.
研究者
Dr Abhijit Chatterjee
Sumandeep Vidyapeeth Deemed to be University