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临床试验/CTRI/2025/07/091352
CTRI/2025/07/091352尚未招募不适用

A Comparative Study on Efficacy of Kashayadhara and Jaladhara in Pre-Hypertension.

Dr Reshmi Babu1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2025年8月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
136
试验地点
1
主要终点
To evaluate the efficacy of Jatamayadi Kashayadhara in Pre-Hypertension when measured in Sphygnomanometer, WHO’s QOL Scale and on the basis of signs and symptoms of Pre-Hypertension.

研究概览

简要总结

This is a randomized, parallel-group, active-controlled, interventional clinical trial designed to compare the efficacy of Kashayadhara (using Jatamayadi Kashaya) and Jaladhara (using plain water) in patients with pre-hypertension. A total of 140 participants diagnosed with pre-hypertension will be randomly allocated into two groups:

• Group A: Kashayadhara

• Group B: Jaladhara

Each intervention will be administered as Shirodhara for 52 minutes daily over 7 days, followed by a late assessment on Day 14.

The primary outcome is the change in blood pressure measured by sphygmomanometer.

Secondary outcomes include improvements in subjective symptoms and WHO Quality of Life Scale (QOL).

The study will be conducted at the Department of Panchakarma, G S Ayurveda Medical college and Hospital, Pilakhuwa, Hapur Dist

This trial aims to explore and validate the efficacy of  Ayurvedic Panchakarma therapies in managing early-stage high blood pressure.

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
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients of Pre hypertension without taking any anti hypertensive drug.
  • Either sex, irrespective of religion and caste.
  • Prehypertension (SBP 120 to 139 mm Hg and DBP 80 to 89 mm Hg).

排除标准

  • Patients below 20 yr and above 50 yr.
  • Patients with Stage 1 HTN and Stage 2 HTN.
  • Patients receiving antihypertensive drug.
  • Patients having any other systemic disease or complications.

结局指标

主要结局

To evaluate the efficacy of Jatamayadi Kashayadhara in Pre-Hypertension when measured in Sphygnomanometer, WHO’s QOL Scale and on the basis of signs and symptoms of Pre-Hypertension.

时间窗: Total duration of study is 14 days | with observation | Initially on the first day before treatment. | On the 7th day after treatment. | On the 14th day for late assessment.

To evaluate the efficacy of Jaladhara in Pre-Hypertension when measured in WHO’s QOL Scale and on the basis of signs and symptoms of Pre-Hypertension.

时间窗: Total duration of study is 14 days | with observation | Initially on the first day before treatment. | On the 7th day after treatment. | On the 14th day for late assessment.

To compare the efficacy of Jatamayadi Kashayadhara and Jaladhara in Pre-Hypertension

时间窗: Total duration of study is 14 days | with observation | Initially on the first day before treatment. | On the 7th day after treatment. | On the 14th day for late assessment.

次要结局

  • Improvement in subjective symptoms of Pre-Hypertension (e.g., headache, dizziness, irritability, fatigue, insomnia, belching, burning sensation)(Improvement in WHO Quality of Life (QOL) score)

研究者

发起方
Dr Reshmi Babu
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Reshmi Babu

Faculty of Indian Medical System, SGT University

研究点 (1)

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