A comparative phytochemical and clinical study on Nagauri Ashwagandha and Nagauri Ashwagandha cultivated using Vrikshayurveda based Kunapajala in Raktagata-Vata with special reference to Essential Hypertention
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- A) Comparative study of both samples of Nagauri Ashwagandha and Nagauri Ashwagandha cultivated using Vrikshayurveda based Kunapajala will reveal whether there is any difference in output of both samples on patients of Raktagata-Vata wsr to Essential Hypertension.
研究概览
简要总结
A comparative Phytochemical and Clinical study on Nagauri Ashwagandha and Nagauri Ashwagandha cultivated using Vrikshayurveda based Kunapajala in Raktagata-Vata wsr to Essential Hypertention
Research Project Aim To compare the effectiveness of two types of Ashwagandha in treating essential hypertension (high blood pressure) with detailed literary review.
Background
Essential hypertension is a widespread health problem.
Ashwagandha, a medicinal herb, is commonly used to treat it, with the Nagauri variety being particularly valued.
Vrikshayurveda is an ancient Indian practice promoting plant growth and phytoconstituents through specific methods.
Research question
Do Ashwagandha cultivated using Vrikshayurveda-based Kunapajala differ in their pharmacological and phytochemical properties compared to conventional cultivation, when used for treating essential hypertension?
Hypothesis
Null hypothesis: There’s no difference between the two types of Ashwagandha.
Alternate hypothesis There’s a significant difference in their characteristics.
Objectives
Primary
Analyze the phytochemical makeup of both Ashwagandha types.
Conduct a clinical trial to assess their effectiveness in treating essential hypertension.
Secondary
Authenticate the Ashwagandha samples using traditional and modern methods.
Monitor any potential reduction in risk factors during the clinical trial.
Methodology
Randomized controlled Clinical study on 2 groups of 30 patients each of essential hypertension.
Sample analysis
Both types of Ashwagandha will undergo
Organoleptic evaluation
Microscopic and macroscopic analysis
Quantitative and qualitative analysis to meet Ayurvedic Pharmacopeia of India standards
Phytochemical analysis at a certified laboratory
Witanolide content testing using LCMS/GCMS methods
Project will contribute to the knowledge of Ashwagandha cultivation using Vrikshayurveda methods and their impact on its medicinal properties for treating essential hypertension.
CLINICAL STUDY:-Drugs will be prepared in pharmacy of BDM College of Ayurveda Sciences, Chhuchhakwas, Jhajjar. Voluntary Essential Hypertension patients with informed consent will be selected for the study. 2 groups will be made. 30 patients will be randomly selected in each group.
Group(A) patients who will take Nagauri Ashwagandha Powder
Group (B) patients who will take Nagauri AshwagandhaPowder cultivated usingVrikshayurvedabasedKunapajala
Sample Size: 60 (30 in each Group)Anupan: with Sukhambu jal
Follow up: patients will be followed up every 15 days
Duration: 45 days
| Group |
A
B
|Number of patients
30
30
|Drug
Nagauri Ashwagandha
Nagauri Ashwagandhacultivated usingVrikshayurvedabasedKunapajala
|Form
Powder
Powder
|Dose
3 gm powder BD
Before meal
3 gm powder BD
Before meal
|Anupan
Sukhambu (Ushnodak)
Sukhambu (Ushnodak)
|Duration
45 days
45 days
PATHOLOGICAL TESTS:-Routine and planned pathological tests will be done before and at the end of study (1st day & 45th day). Close Monitoring of Systolic and diastolic blood pressure, Kidney function test, Cholestrol examination and ECG will be done as required and patients will be confirmed for Essential Hypertension. General laboratorial tests will be done as per need.
Improvement will be observed in both groups according to ayurvedic text and modern text.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with the signs and symptoms of Raktagata-Vata supplemented with that of Essential Hypertension is the main criteria for diagnosis.
- •Patients in the age group 18 years to 60 years.
- •Patients who will be giving written consent after providing complete information about the Nagauri Ashwagandha cultivated using Vrikshayurveda based Kunapajala and making process of Kunapajala.
- •Patient having normal Cholesterol level, Kidney function test and ECG findings.
排除标准
- •Patients having abnormal Cholesterol level, Kidney function test and ECG findings.
- •Pregnant females
- •Patient having Secondary Hypertension due to known pathology.
- •Patients having age less than 18 years and more than 60 years
- •Patients who will not provide written consent after providing complete information about the Nagauri Ashwagandha cultivated using Vrikshayurveda based Kunapajala and making process of Kunapajala.
结局指标
主要结局
A) Comparative study of both samples of Nagauri Ashwagandha and Nagauri Ashwagandha cultivated using Vrikshayurveda based Kunapajala will reveal whether there is any difference in output of both samples on patients of Raktagata-Vata wsr to Essential Hypertension.
时间窗: 45 th day
次要结局
- Clinical Study will reveal whether Ashwagandha is very much beneficial in treating Essential hypertension as single herb or not(45 days)
研究者
UDESH KUMAR
Institute for Ayurveda Studies and Research, SKAU, Kurukshetra, Haryana