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临床试验/CTRI/2024/09/073923
CTRI/2024/09/073923尚未招募不适用

Efficacy evaluation clinical trial of Anti Hypertensive Herbal Syrup developed by DIBER(DRDO) Haldwani

Defence Institute of Bio-Energy Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月20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
60
试验地点
1
主要终点
Lowering of Blood Pressure in Hypertensive Patient

研究概览

简要总结

The present clinical study "Efficacy Evaluation/Clinical Trial of Herbal Product Anti-Hypertensive Herbal Syrup" will be undertaken with the following aims and objectives-

Method of data collection: -

Review of Literature will be collected from central library as well as Post Graduate Library, and from Authentic Research Journals, Websites, Digital publications etc.

1.A Clinical survey of patient attending O.P.D & I.P.D of Panchakarma & Kaya Chikitsa Dept. Govt. Ayurvedic College & Hospital, Varanasi will be made and patients fulfilling the criteria will be selected for the study regardless of sex, religion& socioeconomic status.

2.Submission and approval of synopsis through IEC and CTRI.

3.The Drugs required for the clinical study will be provided by DIBER, DRDO.

Selection of Cases:

1.For purpose of clinical trial cases of Hypertension patients will randomly be selected regardless of age, sex, occupation and socio-economic conditions, from Kaya Chikitsa & Panchakarma O.P.D and I.P.D of Govt. Ayurvedic College and  Hospital, Varanasi.

2.Careful clinical examination and all necessary lab investigations will be performed as per proforma.

3.After diagnosis is established, the patients will be included for clinical trial.

4.The patients will be asked to stop all the previous medications except the trial medication.

研究设计

研究类型
Interventional
盲法
None

入排标准

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

入选标准

  • 1.Patients are selected irrespective of sex, occupation, caste, etc.
  • 2.The patients between ages of 20 to 60 years are included in the study.
  • 3.Patients with classical signs and symptoms of Hypertension will be taken for the study.

排除标准

  • Subjects associated with systemic illness such as Diabetes, Cancer, CKD.
  • Patients who leave the treatment in between.
  • Subjects with anatomical deformity.
  • Subjects with pregnancy.

结局指标

主要结局

Lowering of Blood Pressure in Hypertensive Patient

时间窗: 1 Month and 2 Month

次要结局

  • Lowering in Lipid Level(3 Month)

研究者

发起方
Defence Institute of Bio-Energy Research
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Prakash Raj Singh

Government Ayurveda College and Hospital

研究点 (1)

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