跳至主要内容
临床试验/CTRI/2024/06/069286
CTRI/2024/06/069286尚未招募2 期

A randomized comparative clinical Study to evaluate the efficacy of Trivruttadi churna and Hingwadi churna in the management of Kaphaja Hridroga with special reference to Chronic Stable Angina Pectoris

National Institute of Ayurveda Jaipur1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Changes present in the CTMT of registered patients with symptoms of chronic stable angina pectoris.

研究概览

简要总结

Coronary artery disease occurs when heart’s blood supply is blocked or interrupted by building up of atheroma in the coronary arteries. They become narrow and blood supply to the heart muscle is restricted. This can cause angina. If coronary artery becomes completely blocked it can cause heart attack. This is a medical emergency. Angina occurs when heart muscles need more blood than it is getting such as during physical activity or during strong emotions. Angina is not a disease but a symptom and warning sign of heart disease. A patient with angina may complain of episodes of chest discomfort, usually described as heaviness, pressure, squeezing, smothering, or choking and only rarely as frank pain. Angina is considered to be ‘chronic’ and ‘stable’ when symptoms are present for at least two months, without changes in severity, character or triggering circumstances. Chronic stable angina has a consistent duration and severity and is provoked by a predictable level of exertion. It can also be provoked by emotional stress. An imbalance between myocardial oxygen supply and metabolic oxygen demand causes the symptoms of angina pectoris and represents a major therapeutic target.

In Ayurveda Literature, the heart is the root of the rasavaha srotas and vitiation of rasa dhatu by morbid dosha leads to heart disease. The etiological factors which lead to vitiation of this srotas include- Aharaja- Guru, Sheeta, Atisnigdham, Atimatram, Samashanam. Vagbhata has mentioned that the dietary habits samashana, vishamashana and adhyashana cause serious fatal diseases including the hridroga. Due to the Agnimandhya, the presence of Ama renders the body metabolically slow and sluggish along with varying degree of blockage of the channels of the body at different levels from gross to molecular level. During its sojourn in these channels, it tends to adhere to the walls thereby narrowing the passages or causes srotorodha. Increased impermeability and sluggishness of the body channels or rasavaha srotas increases resistance and compel to pump blood more vigorously and the burden on the heart.  There are 5 types of Hridroga namely Vataja hridroga, Pittaja hridroga, Kaphaja hridroga, Tridoshaja hridroga and Krimija hridroga. The etiopathogenesis of chronic angina pectoris has in order resembled any existing Kaphaja Hridrogaentity in particular.

NEED OF STUDY

Despite important advancements in the pharmacotherapy of Chronic Stable Angina Pectoris, the actual percent reduction in mortality associated with the use of modern pharmacological agents has been relatively unpretentious. Moreover, the available pharmacological agents are also not free from various adverse effects. Hence there is an immense requirement of certain Ayurvedic drugs which can increase efficiency and performance of compromised heart for healthy living in a natural way with least possible adverse effects.

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 59.00 Year(s)(—)
性别
All

入选标准

  • Patients with evidence of chronic stable angina pectoris including cases with controlled hypertension and controlled type 2 diabetes mellitus without complications and not on insulin.
  • Any patient on conventional treatment for at least one month and having symptoms of chronic stable angina pectoris.

排除标准

  • Patients with the history of unstable angina pectoris, acute myocardial infarction, severe valvular defects, congenital heart disease, pericarditis, arrhythmia, congestive heart failure.
  • Patients with the history of extra cardiac ailments like renal failure, uncontrolled hypertension, uncontrolled type 2 diabetes mellitus with or without complications, type 1 diabetes mellitus.
  • Patients with ejection fraction less than 40%.
  • Chronic alcoholics, pregnant and lactating mothers.

结局指标

主要结局

Changes present in the CTMT of registered patients with symptoms of chronic stable angina pectoris.

时间窗: At baseline and at the end of 60 days of treatment.

次要结局

  • 1. Changes present in the ECG and 2D echocardiography of registered patients with symptoms of chronic stable angina pectoris.2. Changes present in the symptoms of Kaphaja Hridroga and chronic stable angina pectoris.(At baseline and at the end of 60 days of treatment.)

研究者

发起方
National Institute of Ayurveda Jaipur
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Litty Mathew

National Instituteof Ayurveda, Jaipur

研究点 (1)

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