Effect of Lotus tea on heart rate variability(HRV) and blood pressure(BP) in patients with primary hypertension – A Randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary outcome of the study will focus on heart rate variability (HRV) parameters, specifically assessing MeanRR (s), SDNN (ms), RMSSD (ms), pNN50%, LF (n.u), HF (n.u), and LF/HF Ratio. These metrics will be evaluated to determine any changes before and after the administration of Lotus tea in patients with primary hypertension.
研究概览
简要总结
The study titled "Effect of Lotus tea on heart rate variability (HRV) and blood pressure (BP) in patients with primary hypertension – A Randomized controlled study" (abbreviated as L-HYVA) aimed to investigate the impact of Lotus tea on HRV and BP in individuals diagnosed with primary hypertension. This randomized controlled trial involved participants aged 30-50 years who were already receiving oral hypotensive medication.
Participants consumed 100 ml of Lotus petal tea daily for 4 weeks, prepared by boiling 20 grams of dried lotus petals in water and taken twice a day before meals. HRV and BP were assessed at multiple time points: baseline, weekly intervals during the intervention period, and one week post-intervention.
The primary outcomes included changes in HRV parameters such as Mean RR, SDNN, RMSSD, pNN50%, LF (n.u), HF (n.u), and LF/HF ratio. Secondary outcomes focused on alterations in systolic and diastolic BP levels.
The study design aimed to provide insights into whether Lotus tea could potentially modulate HRV and BP in hypertensive patients, contributing to the growing body of research on natural interventions for cardiovascular health management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with primary hypertension and on oral hypotensive drugs with blood pressure above 140/90 mmHg, aged between 30 and 50 years no restrictions on gender or race and willing to participate in the study.
排除标准
- •included a history of surgery within the past year, women who are pregnant, menstruating, or lactating, patients over 50 years old, and those with hypertension associated with systemic complications such as diabetes or obesity.
结局指标
主要结局
The primary outcome of the study will focus on heart rate variability (HRV) parameters, specifically assessing MeanRR (s), SDNN (ms), RMSSD (ms), pNN50%, LF (n.u), HF (n.u), and LF/HF Ratio. These metrics will be evaluated to determine any changes before and after the administration of Lotus tea in patients with primary hypertension.
时间窗: Baseline and post intervention
次要结局
- Blood pressure(Baseline: Before the intervention begins.)
研究者
Dr Pandiaraja
International institute of yoga and naturopathy medical science