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临床试验/CTRI/2024/04/065234
CTRI/2024/04/065234尚未招募3 期

Randomized controlled clinical study to evaluate the efficacy of Pushkarmuladi kwath as an adjuvant therapy in vataj hridrog with special reference to stable angina

Vd Ketaki Raghuveer Ramdas1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月11日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Improvement in Stress test (trade mill test)

研究概览

简要总结

Hridroga (Heart disease) is very common in present scenario due to the sedentary life style and increase psychosocial stress. The major causative factors i for heart problems are cigarette smoking, tobacco chewing, alcohol consumption, junk foods and obesity. According to WHO Ischemic heart disease or Coronary artery disease is the major causes of mortality. Therefore, it is needed to explore knowledge of heart disease time to time. The main purpose of this reserch is to promote the awareness about the heart disease, so prevalence of such problem can be reduced. Hridroga is among those diseases mentioned in Ayurveda where in the description is quite brief and the Ayurvedic view point needs clarification. In view of the increasing evidence of cardiac disorders in the present times this aspect assumes added importance.

Among the five types of Hridroga described, in Vatika variety Ayurveda seems to have conceived the disease entity that comes under Angina. Stable angina is effectively managed in  modern medicine with the aim of relief in pain, normalization of ECG changes, and improvement in exercise tolerance and health related quality of life and overall survival. But still many patients are left untreated or improperly treated due to drug tolerance, serious adverse effects, un affordable cost price of the treatment and poor accessibility despite best treatment modalities available. And for a group of refractory angina patient a novel effective drug is required. Therefore, "Randomized controlled clinical study to evaluate the efficacy of Pushkarmuladi kwath as an adjuvant therapy in Vataj Hridrog with special reference to stable Angina" study was undertaken.

In this study 60 patients will be randomly selected showing signs and symptoms of Vataj Hridrog and are randomised into 2 groups. Trial group will be treated with stanandard treatment with Pushkarmaladkwath as an adjuvant therapy while control group will be treated with standard treatment only. In clinical study patients will be examined according to subjective criteria which includes Chest pain (Hridshoola Bheda), Palpitation (Hrid dravah), Sweating, Vertigo (Moha), Fatigue (Shosha), NYHA (New York Heart Association) Score for Angina and objective criteria including ECG (Electrocardiogram) (Before and After treatinent) 2. TMT (Treadmill Machine Exercise Stress Test) (Before and After treatment) 3. Physical haemodynamic tests: (At each follow up) i. Heart Rate (HR) ii Systolic Blood Pressure (SBP) iii. Diastolic Blood Pressure (DBP) 4 Laboratory Blood Chemistry Tests as under: 1. CBC (Complete Blood Count) II. Lipid Profile before treatment and 45 days after treatment. The observations will be drawn after completion of clinical study and conclusion will be drawn accordingly. The study will be published after completion of trial.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with signs and symptoms of Stable Angina e.g chest pain, palpitation, sweating, fatigue,vertigo 2)Patient who met NYHA (New York Heart Association) criteria for Angina(Grade I,II and III).

排除标准

  • Patients who had previous revascularization CABG(Coronary Artery Bypass Graft), PTCA (Percutaneous Transluminal Coronary Angioplasty) stenting.
  • Patients being evaluated for other cardiac diseases except stable angina(e.g valvular disease, etiology of cardiomyopathy, Myocardial infraction, Evidence of heart failure) 3) Pregnant woman and lactating mother..
  • Other major co-existing illnesses like chronic anemia, malignancy, renal or hepatic disease, stroke, auto-immune diseases.
  • Refusal to give informed consent.
  • Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C or patients taking immunosupressive drugs.

结局指标

主要结局

Improvement in Stress test (trade mill test)

时间窗: 45 days

次要结局

  • Improvement in lipid profile and ECG(45 days)

研究者

发起方
Vd Ketaki Raghuveer Ramdas
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Vd Ketaki Raghuveer Ramdas

Ayurved Seva Sanghas Ayurved Mahavidyalaya Nashik

研究点 (1)

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