Role of homoeopathic medicines in management of stress in essential hypertension patients in the age group of 35-80 years.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Improvement (i.e. Reduction in score after the study) in Perceived Stress Scale Score (PSS) used for stress assessment BEFORE and AFTER the study.
研究概览
简要总结
Use of homeopathic remedies in the treatment of HTN is proved effective clinically, but more scientific researches need to be done. Managing an individual having HTN with homeopathic drugs is an art. In case of primary/essential HTN, homeopathy is concerned with the patient having high blood pressure rather than the hypertension itself. It is the sick man who has to restore to health, not his tissues, not his body. It is the constitutional makeup (inherited or acquired) of an individual and the environmental influences (internal or external) that predispose a person to develop HTN. Most patients associated stress as the cause for hypertension. There are many medicines in various ,material medicas which have indications that they could be useful in stress management of essential hypertension patients. Hence I want to conduct this study to assess the role of homoeopathic medicines in reducing stress and in the effectiveness of treatment of essential hypertension patients.
Aim and Objective of the Study :
AIM : To evaluate role of homoeopathic medicines in management of stress in treatment of essential hypertension patients and see its effect on levels of blood pressure.
Primary objective :
- To reduce stress of mild to moderate essential hypertension patients and see its effect on levels of blood pressure.
Secondary objectives :
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To analyse the role of homoeopathic medicines in management of stress in essential hypertension patients.
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To see effect of stress reduction on levels of blood pressure.
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To assess the stress levels before and after the treatment.
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To assess quality of life of patients before and after the treatment.
HYPOTHESIS :
Null hypothesis
Homoeopathic medicines have no significant effect in reducing stress of essential hypertension patients and in the management of their elevated blood pressure levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 35.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of both sexes & age group between 35-80 yrs.
- •Patients presenting with pre-diagnosed mild to moderate essential hypertension without any major systemic complications whose exciting or maintaining cause of essential hypertension is identified to be stress.
- •Patients on allopathic treatment for essential hypertension fulfilling above two inclusion criterias will be enrolled.
- •Patients on no allopathic or no homoeopathic treatment (from other doctors for essential hypertension treatment) fulfilling the first two inclusion criterias will be enrolled.
- •The ability to give informed consent & comply with study procedures.
排除标准
- •Pregnant or lactating women with essential hypertension.
- •Patients with severe essential hypertension.
- •Patients with secondary hypertension.
- •Patients who require emergency medical interventions or Severe co-morbidities.
- •Patients on homoeopathic treatment for essential hypertension from another doctor will be excluded.
- •Simultaneous participation in other clinical studies or completion of participation in a study less than 6 months prior (patients are to be explicitly asked about this).
结局指标
主要结局
1. Improvement (i.e. Reduction in score after the study) in Perceived Stress Scale Score (PSS) used for stress assessment BEFORE and AFTER the study.
时间窗: 1. Improvement (i.e. Reduction in score after the study) in Perceived Stress Scale Score (PSS) used for stress assessment at baseline and after 3 months. | 2. Improvement in SF36 (by RAND) used for Quality of life assessment of the essential hypertension patients at baseline and after 3 months.
2. Improvement in SF36 (by RAND) used for Quality of life assessment of the essential hypertension patients BEFORE and AFTER the study.
时间窗: 1. Improvement (i.e. Reduction in score after the study) in Perceived Stress Scale Score (PSS) used for stress assessment at baseline and after 3 months. | 2. Improvement in SF36 (by RAND) used for Quality of life assessment of the essential hypertension patients at baseline and after 3 months.
次要结局
- Improvement in essential hypertension assessed by reduction in levels of blood pressure after 3 months of treatment.(Changes in levels of blood pressure at baseline and after 3 months of treatment.)