Efficacy of Individualized Homoeopathic Medicines In The Treatment Of Stage-I Essential Hypertension In Adults : A Double Blind, Randomized, Placebo_ Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- To detect the group difference between individualized homoeopathic medicines and identical looking placebo in
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
To detect the group difference between individualized homoeopathic medicines and identical looking placebo in
Time Frame: After 3 months of intervention
systolic blood pressure (SBP) and diastolic blood pressure (DBP) in essential hypertension
Time Frame: After 3 months of intervention
stage-I.
Time Frame: After 3 months of intervention
Secondary Outcomes
- 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.)
Investigators
DR RESHMI KHATUN
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital