跳至主要内容
临床试验/CTRI/2025/05/087304
CTRI/2025/05/087304尚未招募2/3 期

A Controlled Double Arm Open Labelled Clinical Trial to Evaluate the Efficacy of Vrusha Ghruta and Kulatthadi Kashaya in the Management of Tamaka Shwasa vis a vis Bronchial Asthma

DR NAYANA D R1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
1)Asthma control questionaire value less than 1.5

研究概览

简要总结

Tamaka Shwasa is one among the five varieties of Shwasa roga manifested due to vitiation of kapha-vata dosha and rasa dhatu in pranavaha srotas, originating from pittastana. Shwasa krichrata, kasa, ghurghuraka and prana peedana are the pradhana lakshana Asthma is defined as a chronic inflammatory disorder of the airways which is associated with airway hyper responsiveness. It leads to recurrent episodes of wheezing, breathlessness, chest tightness and coughing particularly at night and in early morning . According to WHO, Globally, Asthma has affected an estimated 262 million people in 2019. The overall burden of asthma in India is estimated to be more than 15 million . Asthma, owing to its chronic nature, has a significant impact on quality of life in patients due to the decreased capacity of physical exertion, constant dependence on medications, decreased quality of sleep, low performance at work and constant fear of trigger factors. The current management of Bronchial Asthma in modern medicine is only providing short term symptomatic relief but does not provide any long-term relief to the patient. On the other hand, prolonged use of these drugs are not safe, as it has many adverse effect with systemic manifestation and as the chronicity increases drug dose dependency increases. Ayurveda is the best way to effectively & safely manage the condition without inducing any drug dependency. Various shodhana procedures and internal medications are advised. They detoxify the body, provides nutrition to tissues, increases the elasticity of lung tissue and develops natural immunity. Thus, decreasing episodic recurrence of the disease and providing long term relief to the patient . Kapha is the sthanika dosha involved in Tamaka shwasa and it will cause obstruction to vata leading to a Pratiloma gati  of vata.kaphavruta vata samprapti is observed in tamaka shwasa and it is important to remove the obstruction and clearing the vata marga. The management protocol for kaphavruta vata includes usage of kaphahara dravya and achieving vatanulomana, lavana taila abhyanga and nadi sweda told as primary treatment in shwasa. Hence Sthanika abhyanga with samudra lavana yukta Vishagarbha taila followed by nadi sweda and Nithya mrudu virechana with Gandharva hastadi eranda taila are selected in the study. Vasa is present in Vrusha ghruta which is kasa shwasahara,hence Vrusha ghruta has been selected for the study. kulatta is also having the property of kasa shwasahara. Hence the present study is designed to compare the efficacy and internally vrusha ghrutha and kulattadi Kashaya in patients of Tamaka Shwasa keeping Nithyavirechana, Lavanataila abhyanga followed by Nadisweda as control in both the groups.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

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

入选标准

  • Subjects fulfilling the diagnostic criteria of Tamaka Swasa.
  • Subjects having peak expiratory flow rate of greter than 50percent of predicted value of Peak Expiratory Flow Rate chart.
  • Subjects within the age group of 18 to 60 years.
  • Both fresh and treated cases.

排除标准

  • Acute condition of Bronchial Asthma, Status Asthmaticus.
  • Subjects suffering from associated diseases like Tuberculosis, pneumonia,Cardiac asthma,Uncontrolled Diabetes mellitus FBS 180ml by dl,Uncontrolled Hypertension BP 160by100mmhg 3) Subjects having peak expiratory flow rate of lessthan 50percent of predicted value of Peak Expiratory Flow Rate chart.
  • Subjects who are on corticosteroids.
  • Pregnant and lactating women.

结局指标

主要结局

1)Asthma control questionaire value less than 1.5

时间窗: 0th day, 8th day, 31st day.

次要结局

  • Symptomatically relief to the patient(0th day 8th day and 31st day)

研究者

发起方
DR NAYANA D R
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR NAYANA D R

Government Ayurveda Medical College and Hospital, Mysuru

研究点 (1)

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