Evaluation of Individualized Homoeopathic Medicines in the Management of elevated BP, stage-I hypertension and associated biochemical markers – A Randomized, Double-blind, Placebo-controlled clinical study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 280
- 试验地点
- 4
- 主要终点
- Primary:
研究概览
简要总结
The title of the study is Evaluation of Individualized Homoeopathic Medicines in the Management of elevated BP stage-I hypertension and associated biochemical markers A Randomized Double-blind Placebo-controlled clinical study. Aim of the study is to assess the clinical efficacy of Individualized Homoeopathic Medicines in the management of elevated BP, stage-I hypertension (American College of Cardiology- 2017) and to evaluate the effect of Homoeopathic medicines on the level of circulating Biochemical markers. The study design is randomized, double-blind, placebo-controlled trial. The study duration 2 years and 6 months. The objectives of the study are
To assess the clinical efficacy of Individualized Homoeopathic Medicines in the management of elevated BP, stage-I hypertension (ACC 2017
To assess the changes in both systolic and diastolic blood pressure. To assess the changes in the level of biochemical parameters (HLDF 24 peptide, TNF superfamily 14 (LIGHT), Amyloid-A, Homocysteine, Interleukin -6, and CRP).Secondary Objectives
To assess the changes in the total and individual domain scores of the SF-36 Health survey score
To assess the changes in the level of serum cholesterol, triglyceride, and HbA1C.
To assess the changes in the ORIDL scores in every follow-up. the sample size of the study is 280.
Outcome Measures
Primary
Changes from baseline systolic and diastolic blood pressure measurements.Time frame During every follow-up of 15 days for the period of 12 month
Changes in the serum level of HLDF 24 peptide, TNF superfamily 14 (LIGHT) Amyloid-A, Homocysteine, Interleukin -6, and CRP. [Time frame: Baseline, 3 months, 6 months, 9 months and 12 months
Secondary
Change in the SF-36-Health Survey Score. Time frame Monthly for 12 months.
Changes in the level of serum cholesterol, triglyceride, and HbA1C Time frame Baseline, 3 months, 6 months, 9 months and 12 months
Change in the ORIDL Score. Time frame During every follow-up of 15 days for the period of 12 months]
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants of either sex aged between 20 and 60 years Participants diagnosed with elevated BP between 120 and 129 or less than 80 mm Hg or Stage 1 hypertension with systolic BP between 130 and 139 mm Hg or diastolic between 80 and 89 mm Hg as per the American College of Cardiology or American Heart Association 2017 Willing and able to participate for 3 months.
排除标准
- •Participants who are already on hypertensive medications.
- •Participants who have a history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, congestive cardiac failure, Stroke, or Severe Arrhythmia in the last 6 months.
- •Participants with Stage-2 hypertension greater than or equal to 140 mm Hg systolic or greater than or equal to 90 mm Hg diastolic, as per the American College of Cardiology or American Heart Association
- •Participants with concurrent Hepatic Dysfunction defined as AST and or ALT greater than 2 times the upper standard limit or Renal Dysfunction defined as S.
- •creatinine greater than 1.2mgdl, uncontrolled diabetes mellitus HbA1C greater than 8, uncontrolled Pulmonary Dysfunction asthmatic and COPD patients, or significant systemic illness necessitating long term drug treatment Rheumatoid arthritis, Neurological disorders, Endocrinal disorders, etc.) or Known cases of malignancy.
- •Women who are planning for conception or pregnancy or lactating.
- •Participants with history of hypersensitivity to homeopathic medicines or any doses form.
- •Participants taking homoeopathic medicines for any other diseases in the last 2 weeks.
结局指标
主要结局
Primary:
时间窗: Changes from baseline systolic and diastolic blood pressure measurements. | [Time frame: During every follow-up of 15 days for the period of 12 months] | Changes in the serum level of HLDF 24 peptide, TNF superfamily 14 (LIGHT), | Amyloid-A, Homocysteine, Interleukin -6, and CRP. | [Time frame: Baseline, 3 months, 6 months, 9 months and 12 months]
1.Changes from baseline systolic and diastolic blood pressure measurements.
时间窗: Changes from baseline systolic and diastolic blood pressure measurements. | [Time frame: During every follow-up of 15 days for the period of 12 months] | Changes in the serum level of HLDF 24 peptide, TNF superfamily 14 (LIGHT), | Amyloid-A, Homocysteine, Interleukin -6, and CRP. | [Time frame: Baseline, 3 months, 6 months, 9 months and 12 months]
2.Changes in the serum level of HLDF 24 peptide, TNF superfamily 14 (LIGHT),
时间窗: Changes from baseline systolic and diastolic blood pressure measurements. | [Time frame: During every follow-up of 15 days for the period of 12 months] | Changes in the serum level of HLDF 24 peptide, TNF superfamily 14 (LIGHT), | Amyloid-A, Homocysteine, Interleukin -6, and CRP. | [Time frame: Baseline, 3 months, 6 months, 9 months and 12 months]
Amyloid-A, Homocysteine, Interleukin -6, and CRP.
时间窗: Changes from baseline systolic and diastolic blood pressure measurements. | [Time frame: During every follow-up of 15 days for the period of 12 months] | Changes in the serum level of HLDF 24 peptide, TNF superfamily 14 (LIGHT), | Amyloid-A, Homocysteine, Interleukin -6, and CRP. | [Time frame: Baseline, 3 months, 6 months, 9 months and 12 months]
次要结局
- Change in the SF-36-Health Survey Score.(Changes in the level of serum cholesterol, triglyceride, and HbA1C.)
研究者
Dr Pankhuri Misra
Dr.D.P. Rastogi Central Research Institute for Homoeopathy