A double-blind, placebo controlled, randomised trial using individualised homoeopathic treatment for modifying anger and thereby reducing blood pressure in patients of essential hypertension against standard care treatment
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Changes in anger variables scores
研究概览
简要总结
BACKGROUND
Hypertension constitutes an important public health issue. It affects 30% of world population according to the latest data. The aetiology of hypertension is various and complex, involving both genetic and behavioural factors. More and more people experience increased anger, anxiety, depression brought on by globalization, cultural changes, socioeconomic changes, and stress at workplace. The effects of anger & hostility on blood pressure are in the focus of researchers for many years. Aside from the intrinsic psychophysiological interest of these effects, this research is also motivated by the possibility that blood pressure may positively correlate with the variables of anger and hostility and thus the risk of hypertension and other cardiovascular diseases would increase.
AIM
To demonstrate the efficacy of the homoeopathic similimum on mild to moderate essential hypertension (EHT) by modifying the underlying anger state – trait and expressions, thus making the patient more capable to cope with the changing life situations as compared to placebo.
OBJECTIVES
- Identifying the anger state – trait and expressions and quantify them with the help of State – Trait Anger Expression Inventory – 2 (STAXI2) in patients having essential hypertension. 2. Correlating the anger state – trait and expressions with systolic and diastolic blood pressure levels. 3. Evaluating the efficacy of homoeopathic similimum on patients with mild to moderate essential hypertension in modifying the underlying anger state – trait and expressions. 4. To study the safety of homoeopathic similimum in patients with mild to moderate essential hypertension in modifying the underlying anger state, trait and expression.
HYPOTHESE:
1. The group of patients that gets the homoeopathic similimum for anger will have better blood pressure control than the group on placebo.
2. There is positive relationship between components of anger and hypertension.
- Individualised homoeopathic treatment is more effective in reducing anger and thereby controlling hypertension than standard antihypertensives.
4. There is no difference in the rate of complication in both the groups.
5. Children of hypertension patients are more prone to hyper-react to stressors and thereby more susceptible to hypertension.
6. EHT can be improved by better anger coping mechanism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of essential hypertension.
排除标准
- •Patients having secondary hypertension Pregnant and lactating women Uncontrolled endocrine disorders Severe psychiatric disorder.
结局指标
主要结局
Changes in anger variables scores
时间窗: At the end of 6 months study period
Changes in blood pressure values
时间窗: At the end of 6 months study period
次要结局
- Reduction in the intensity of comorbid conditions(Follow up every 2 weeks to assess subjective and objective criteria)
