Health Condition 1: I00-I99- Diseases of the circulatory system
Conditions
Interventions
Intervention1: Individualized Homoeopathy with Standard care
: Group 1, All participants will be given Individualized homoeopathic medicine in Centesimal potency customized to each participant. Repeti
Sponsors
Central Council for Research in Homoeopathy
Eligibility
Inclusion criteria
Inclusion criteria: Participants aged 45 years to 80 years. All genders Established case of cardiac arrhythmias of any cause, with presence of arrhythmia-related signs and symptoms such as irregular heartbeats, palpitations, breathlessness, dizziness, chest pain, cold sweat, weakness & fatigue, pressure/discomfort in chest, worry/anxiety, history of syncope or any episode of unconsciousness, as judged by the investigator and on standard care. Participants who are under existing Standard care (conservative management) for Cardiac Arrhythmia Ability to comply with the study protocol Voluntary written Informed consent
Exclusion criteria
Exclusion criteria: Known participant of stage 4 heart failure that is NYHA class 4 Participants who are known case of ventricular fibrillation Participants with severe ventricular dysfunction characterized by left ventricular ejection fraction less than 30 percentage Participants with pacemaker implant or previous use of defibrillators Participants with other known systemic illnesses such as cancer, HIV, CKD with dialysis, uncontrolled diabetes mellitus, uncontrolled thyroid disorders et cetera Participants has any clinically relevant medical or surgical condition that in the opinion of the investigator would put the person at the risk by Participating in the study Participants travelling during the study Participation period that prevents planned office or hospital visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effectiveness of homoeopathy as an add-on treatment to standard care in the management of cardiac arrhythmia as assessed by the change in the score of Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA) every month over a period of 6 months.Timepoint: Baseline (0), Months 1,2,3,4,5 & 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of add-on homoeopathy on Quality of Life (patient satisfaction, adherence to treatment, & perceived effectiveness using EQ-5D-5L at baseline (0), 3rd month & 6th monthTimepoint: Baseline (0), Months 1,3 & 6;To assess the effect of add-on homoeopathy in reducing the frequency & severity of Arrhythmia episodes as recorded by 24-Hour Holter monitoring among the two groups at Baseline (0), 3rd & 6th months.Timepoint: Baseline (0), Month 3 & 6;To assess the effect of add-on homoeopathy on the reduction of standard care drugs among the two groups over 6 monthsTimepoint: Baseline (0) & Month 6;To access proportion of participants requiring pacemaker, defibrillator and surgical intervention over a period of 6 months during the trial.Timepoint: Over a period of 6 months;To assess the effect of add-on homoeopathy on cardiac biomarkers such as cardiac troponin I, NT-pro BNP Test, creatinine kinase (CK), CK-MB, and Myoglobin at Baseline (0), 3rd and 6th monthsTimepoint: Baseline (0), Month 3 & 6;To assess the effect of add-on homoeopathy on other blood parameters like CRP, Lipid profile, LFT, KFT, serum creatinine, fasting plasma insulin, HbA1C, serum sodium, magnesium, and potassium, at Baseline (0), 3rd and 6th month.Timepoint: Baseline (0), Month 3 & 6;To assess the safety of add-on homoeopathy relative to control in terms of proportion in the occurrence of adverse/ serious adverse events related to cardiovascular/non-cardiovascular pathologies over a period of 6 monthsTimepoint: Over a period of 6 months | — |
Countries
India
Contacts
Public ContactDr Varanasi Roja
SRM Institute of Science and Technology
Outcome results
None listed