Comparative evaluation of the effectiveness of Terminalia arjuna and Guatteria gaumeri in the management of dyslipidemia: A randomized controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percent reduction in lipid levels from baselineline score after intervention
研究概览
简要总结
Dyslipidemia encompasses elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-c), TGs, or low HDL-c. It is a well-established risk factor for cardiovascular disease (CVD). Elevated LDL-c is a major contributor to atherosclerosis, and low HDL-c is also linked to CVD.1 These conditions are prevalent and often linked to genetic predispositions, environmental factors (such as diet, lifestyle, and medical conditions), and can significantly increase the risk of atherosclerotic cardiovascular disease (ASCVD). Elevated triglycerides can also lead to acute pancreatitis, necessitating intervention
Dyslipidemia is a global public health problem that affects millions of people and increases the risk of cardiovascular disease, the leading cause of death worldwide. The epidemiology of dyslipidemia varies by region, age, sex, and ethnicity and is influenced by genetic and environmental factors.
Despite the widespread use of statins and other medications for treating dyslipidemia, there is growing interest in exploring alternative therapies. Homeopathic remedies are being considered for their potential to lower elevated lipid levels without the adverse side effects often associated with conventional treatments, which are typically lifelong and pose health risks to patients. Given that dyslipidemia is a key factor in conditions like ASCVD, insulin resistance, type 2 diabetes, NAFLD, PCOD, and metabolic syndrome, safer, holistic approaches to treatment are needed.6 Homeopathy, which focuses on individualized patient care, may offer such an approach. However, the specific roles of remedies like Terminalia arjuna and Guatteria gaumeri in dyslipidemia management have not been adequately studied, making this an important area for further research in homeopathy.
Research question-
Is there any significant difference between cases of dyslipidemia receiving predefined medicines Terminalia arjuna and cases receiving Guatteria gaumeri?
Hypothesis:
Null Hypothesis (H0) – There is no significant difference in the lipid-lowering effects between Terminalia Arjuna and Guatteria Gaumeri in patients with dyslipidemia
Alternate hypothesis (H1) – There is significant difference in the lipid-lowering effects between Terminalia Arjuna and Guatteria Gaumeri in patients with dyslipidemia
Alternate hypothesis (H2) – Terminalia arjuna is more effective in cases of dyslipidemia than Guatteria Gaumeri.
Alternate hypothesis (H3) – Guatteria Gaumeri is more effective in cases of dyslipidemia than Terminalia arjuna.
Alternate hypothesis (H4) – Terminalia arjuna is not effective in cases of dyslipidemia.
Alternate hypothesis (H5) – Guatteria Gaumeri is not effective in cases of dyslipidemia.
AIM & OBJECTIVE
Aim
To assess and compare the effectiveness of Terminalia Arjuna and Guatteria Gaumeri in managing lipid profiles among patients with dyslipidemia.
Objective
To evaluate and compare the effects of Terminalia Arjuna and Guatteria Gaumeri on lowering LDL cholesterol, total cholesterol, and triglycerides in patients diagnosed with dyslipidemia.
To assess the impact of Terminalia Arjuna and Guatteria Gaumeri on increasing HDL cholesterol levels.
To determine the overall improvement in lipid profiles between the two treatment groups.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of Dyslipidemia: Participants must have a confirmed diagnosis of dyslipidemia, characterized by abnormal lipid levels.
- •Age Group: Adults aged 18-65 years of both sexes.
- •Willingness to Participate: Participants must be willing to follow the study protocol, attend follow-up visits, and adhere to the prescribed treatment (either Terminalia Arjuna or Guatteria Gaumeri).
- •Signed Informed Consent.
排除标准
- •Severe Cardiovascular Conditions with a history of recent cardiovascular events within the last six months.
- •Existing Treatment for Dyslipidemia: Patients who are currently on any other lipid-lowering medications (e.g., statins, fibrates) and unwilling to discontinue or who cannot discontinue for medical reasons.
- •Chronic Liver or Kidney Disease: Individuals with severe liver disease or renal insufficiency, as these conditions could interfere with lipid metabolism or the safety of the remedies.
- •Pregnancy or Lactation.
- •Use of Alternative or Complementary Medicines: Patients using other herbal or alternative treatments that may interfere with lipid levels.
- •Severe Mental Health Conditions: Individuals with unmanaged psychiatric conditions that may impact adherence to the study protocol or affect their ability to give informed consent.
结局指标
主要结局
Percent reduction in lipid levels from baselineline score after intervention
时间窗: 3 months after intervention
次要结局
- Weight loss,(3 months after intervention)
研究者
Nipun Singh Dabi
Madhav Homoeopathic Medical College and Hospital