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临床试验/CTRI/2024/11/077329
CTRI/2024/11/077329招募中3 期

Prospective Single Arm Open Clinical Trial To Study The Efficacy Of Padmakadi Avaleha In Management Of Kaphaja Kasa With Special Reference To Bronchitis.

Dr Supriya Maruti Ghorpade1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月6日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
To evaluate the efficacy of Padmakadi Avaleha in Kaphaja Kasa.

研究概览

简要总结

Single arm open Clinical Trial

This study is conducting for evaluate efficacy of Padmakadi Avaleha in management of Kaphaja Kasa with special reference to Bronchitis.

After screening patients at OPD and IPD level 30 patients will be selected for trial , informed written consent will be taken in native language.

Kaphaja Kasa often best compared with bronchitis due to similarities of sign and symptoms. According to estimate from National Interview taken by National Center for Health Statistics 9.5 Million or 4% of population were diagnosed with Bronchitis. According to Pub Med Central Article, latest prevalence rate of bronchitis varies throughout the world from 3.4% - 22% in general population.

Null Hypothesis

Padmakadi Avaleha 10 gm orally twice a day for 14 days is not effective in Kaphaja Kasa with special reference to Bronchitis.

Alternate Hypothesis

Padmakadi Avaleha 10 gm orally twice a day for 14 days is effective in Kaphaja Kasa with special reference to Bronchitis.

Drug - Padmakadi Avaleha

 

Dose - 10 gm twice a day

Anupana - Koshna Jala

Sevan Kala - Vyanodana (After Food)

Duration - 14 Days

Follow up - 7th day and 14th Day

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
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients presenting with symptoms of Kaphaja kasa (Bronchitis) with kasa Vega (Bouts of cough),Kapha Nishthivan(Sputum Production),Shwaskrichata(Breathlessness),Urashool(Chest pain while coughing),Peenas(Common cold),Aruchi(Tasteless)as described in Ayurvedic Classics 2)Patients age between 18yrs to 70yrs of either sex 3)Patients without any bar of caste,religion, occupation, socioeconomic status.

排除标准

  • Patients with known case of TB, Lung Cancer, Interstitial Lung Disease, Pneumonia, Pneumothorax 2)Patients with serious illness like HIV, Malignancy, Severe Cardiac Disease, Uncontrolled DM,Hepatic Disorder, Stroke, Arrhythmia or Evidence of Heart Failure and Auto Immune Disorder 3)Pregnant Women and Lactacting Mother.

结局指标

主要结局

To evaluate the efficacy of Padmakadi Avaleha in Kaphaja Kasa.

时间窗: 7th day and 14th day

次要结局

  • 1.To evaluate any adverse effects of Padmakadi Avaleha in Kaphaja Kasa if any.

研究者

发起方
Dr Supriya Maruti Ghorpade
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Supriya Maruti Ghorpade

Sheth Chandanmal Mutha Aryangla Vaidyak Mahavidyalaya Satara

研究点 (1)

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