Health Condition 1: I131- Hypertensive heart and chronic kidney disease without heart failure
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Individualized homoeopathy and Standard care: All participants in this group shall receive individualized homoeopathic treatment along wi
Sponsors
Central Council for Research in Homoeopathy, New Delhi, India
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 1. 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. 2. Participants with known secondary hypertension. 3. Known participant of stage III and stage IV chronic heart failure. 4. Participants with chronic kidney disease (Stages G3b, G4, G5). 5. Participants who had undergone any major surgery in the past 6 months. 6. Pregnant ladies and breastfeeding mothers. 7. Participants with known mental ailments like schizophrenia and other psychotic conditions. 8. Participants with known systemic illness like cancer, HIV, genetic disorders etc. 9. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the changes in blood pressure (SBP/DBP) values over 6 months.Timepoint: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the changes in the quality of life using SF-36 questionnaire among the two groups at baseline and at month 6.Timepoint: 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.Timepoint: 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. Timepoint: Baseline and Month 6.;To assess the changes in cardiac biomarker like cardiac troponin at baseline and at month 6.Timepoint: 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. Timepoint: Baseline and Month 6.;To assess the reduction of standard care drugs among the two groups over the period of 6 months.Timepoint: 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. Timepoint: Baseline and Month 6. | — |
Countries
India
Contacts
Public ContactDr Varanasi Roja
Central Council for Research in Homoeopathy
Outcome results
None listed