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临床试验/CTRI/2024/05/068059
CTRI/2024/05/068059已完成3 期

Clinical Evaluation Of Siddha Formulation Drakshai Chooranam In The Management Of Essential Hypertension among The Patients Attending Ayothidass Pandithar Hospital Nis

National Institute of Siddha1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月16日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
30
试验地点
1
主要终点
To evaluate the clinical effectiveness of siddha formulation Drakshai chooranam in the management of Essential hypertension through sphygmomanometer

研究概览

简要总结

BACKGROUND:

Siddha system of medicine provides rejuvenated health care based on the principles of panchayat boodham. The Siddha medicines are broadly classified into 32 Internal medicines & 32 external medicines which play a significant role in the treatment & management of various diseases.

Hypertension is a very common disorder that doubles the risk of cardiovascular diseases, including coronary heart disease(CHD), congestive heart failure(CHF), ischemic and hemorrhagic stroke, renal failure, and peripheral arterial disease(PAD).

The pathogenesis of Essential hypertension is not clearly understood. Different investigators have proposed the kidney, the peripheral resistance vessels and the sympathetic nervous system as the seat of primary abnormality.

In reality, the problem is probably multi-factorial. Hypertension is more common in some ethnic groups and approximately 40 to 60 % is explained by genetic factors Important environmental factors include a high salt intake, heavy consumption of alcohol, obesity, lack of exercise and impaired intrauterine growth.

Hypertension occasionally causes headaches but, most patients remain asymptomatic. Accordingly, the diagnosis is usually made at a routine examination or when a complication arises. A blood pressure check is advisable every 5 years in adults.

An estimated 1.28 billion adults aged 30-79 years worldwide have hypertension, most (two-thirds)living in low- and middle-income countries. An Estimated 46% of adults with hypertension are unaware and less than half of adults (42%) are diagnosed and treated.

One of the global targets for non-communicable diseases is the reduction of the prevalence of hypertension by 33% between 2010 and 2030. It is estimated that at least one in four adults in India has hypertension, but only 12% of them have their blood pressure under control.

India has set a target of a 25% relative reduction in the prevalence of hypertension (raised blood pressure) by 2025. The overall prevalence of hypertension was 33% and higher among sedentary type (41%) in Tamil Nadu

PRIMARY OBJECTIVE:

To evaluate the clinical effectiveness of siddha formulation DRAKSHAI CHOORANAM  in the management of  Essential hypertension through sphygmomanometer

SECONDARY OBJECTIVE:

To assess the quality of life in patients with hypertension through the SF-36 questionnaire

STUDY DESIGN:

An open non non-randomised clinical trial with 30 patients diagnosed with essential hypertension reporting at Ayothidass Pandithar Hospital National Institute of Siddha will be enrolled in the study. Patients with Stage I  systolic ≥140-≤159/ diastolic ≥90-≤99 mmHg (According to JNC 8 guidelines) will be included and patients with Stage 2 systolic   ≥160 / diastolic ≥110 mmHg, K/c/o  diabetes mellitus, liver diseases, kidney disease, hematopoietic disease, malignant tumour, cardiovascular diseases, cerebrovascular diseases, white collar hypertension and pregnant women are excluded. The trial drug Drakshai chooranam as internal medicine will be given for 48 days along with 2 month follow up

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 59.00 Year(s)(—)

入选标准

  • Age 18 to 59 years(All Gender) Stage I hypertension (According to JNC 8 guidelines).

排除标准

  • Age above 60 years K/c/o liver diseases kidney disease hematopoietic disease malignant tumour cardiovascular diseases cerebrovascular diseases white collar hypertension Stage 2 hypertension Pregnant women Patients who are taking anti-hypertensive medications.

结局指标

主要结局

To evaluate the clinical effectiveness of siddha formulation Drakshai chooranam in the management of Essential hypertension through sphygmomanometer

时间窗: 4 months screening | 4 months patient enrollment | 4 months outcome assessment

次要结局

  • To assess the quality of life in patients with hypertension through SF-36 questionnaire(4 months screening)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr C Cilfa

National Institute Of Siddha

研究点 (1)

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