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临床试验/CTRI/2024/04/066008
CTRI/2024/04/066008尚未招募不适用

Analysis of Siddha Naadi (pulse) examination in Hypertension – A Blinded Diagnostic Study

未提供1 个研究点 分布在 1 个国家目标入组 516 人开始时间: 2024年4月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
516
试验地点
1
主要终点
Specificity and Sensitivity of Naadi examination for the diagnosis of Hypertension will be obtained.

研究概览

简要总结

Naadi is a non-invasive, no instrument, cost effective diagnostic tool which does not require any prior preparation that can be done at any time. This study will determine the usefulness of Naadi as a screening tool in diagnosis of Hypertension.

Primary objective:

·To determine the diagnostic accuracy of Naadi in diagnosing Hypertension.

Secondary objective:

·To document difference in Naadi pattern in different grades/stages of Hypertension.

·To document the Yakkai Ilakkanam for Hypertensive patients through validated questionnaires.

Study type:

Diagnostic study

STUDY DESIGN:

Blinded diagnostic study

Study place:

Outpatient and Inpatient department,

Ayothidoss Pandithar Hospital,

National Institute of Siddha,

Chennai-600047.

Study period:

18 months.

SAMPLE SIZE: 172

HYPERTENSIVE PATIENTS: 172

HEALTHY VOLUNTEERS: 344

PRIMARY OUTCOME:

Specificity and Sensitivity of Naadi examination for the diagnosis of Hypertension will be obtained.

SECONDARY OUTCOME:

Different Naadi patterns if observed in different grades/stages of Hypertension will be documented.

Yakkai Ilakkanam for Hypertensive patients will be documented through validated questionnaires.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age: 20-60 Sex: Male, Female, Transgender Patients who are diagnosed with Hypertension as per ASH (American Society of Hypertension) guidelines.
  • Patients who are willing to sign consent form.

排除标准

  • Patients who is not willing to participate in study.
  • Patients with systemic illness.
  • Vulnerable group (pregnant women, children, geriatric and cognitive impaired patients).

结局指标

主要结局

Specificity and Sensitivity of Naadi examination for the diagnosis of Hypertension will be obtained.

时间窗: BASELINE 0TH DAY

次要结局

  • Different Naadi patterns if observed in different grades/stages of Hypertension will be documented.(Yakkai Ilakkanam for Hypertensive patients will be documented through validated questionnaires.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

D KRISHNAAVENI

NATIONAL INSTITUTE OF SIDDHA

研究点 (1)

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