跳至主要内容
临床试验/CTRI/2024/07/070457
CTRI/2024/07/070457尚未招募Phase 3 4

Evaluation of Hridya Mahakashaya churna in Hridroga (CHF)and its relation with Prakriti and Agnibala

Dr Ragini Joshi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年7月22日最近更新:
适应症
相关药物

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
The effect of Hridya Mahakashaya on Hridroga patients has relation with Prakriti and Agnibala.

研究概览

简要总结

Patients will be randomly divided into two groups. GROUP A (TRIAL) – will be given powder (churna) from 3 grams thrice daily with luke warm water in addition to standard allopathic care.  GROUP B (CONTROL) – given standard allopathic heart failure medications.Treatment Period – First 3 Months ,with medication. Follow up period –  every 1 month.  Another 3 months, post-medication follow up.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • •Subjects of either sex belonging to age between 40 to 60 years ,diagnosis of heart failurefor at least 2 months are eligible, if they are fulfilling the criteria described in New York Heart Association (NYHA) functional class II or class III i.e mild or moderate patients,have a left ventricular ejection fraction documented to be ≤ 40% within the last 12 months are taken.
  • •Volunteers willing to be the part of the study by giving written consent in prescribed format.

排除标准

  • •The patients with age below 40 years and above 60 years.
  • •Patients coming under the criteria described in New York Heart Association (NYHA) functional class IV i.e severe patients of heart failure Patients with known case of Myocadial Infaction (MI) Volunteers having any type of recurrent or chronic illness History of any known disease/illness, tuberculosis, malignancy, severe anemia or any other acute disease.

结局指标

主要结局

The effect of Hridya Mahakashaya on Hridroga patients has relation with Prakriti and Agnibala.

时间窗: Evaluation will be done after 6 months

And it will assessed by Objective parameters like Electrocardiogram, Echocardiogram of patients on the follow ups and by subjective parameters like filling the standard proforma for prakriti and agnibala before and after the intervention.

时间窗: Evaluation will be done after 6 months

次要结局

  • The prevalence of Hridroga depend upon the Prakriti & Agnibala of an individual.it will be assessed by filling valid proforma for prakriti & agnibala before the intervention in the patients.(3 months)

研究者

发起方
Dr Ragini Joshi
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ragini Joshi

Banaras Hindu University

研究点 (1)

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