跳至主要内容
临床试验/CTRI/2017/12/010845
CTRI/2017/12/010845招募中2 期

“Comparative Study of Efficacy of ‘Shunthyadi Churna’ and ‘Parnasapanchaka Kwatha’ in the Management of Tamaka Shwasa with special reference to Bronchial Asthmaâ€.

National Institute of Ayurved1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年6月11日最近更新:

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Patients of either sex 18-60 yr old diagnosed with tamaka shwasa (Bronchial asthma) will be selected for relief in sign and symptoms

研究概览

简要总结

Tamaka Shwasa is a type of  Shwasa Roga in which patients feel excessive difficulty in breathing and drowning in dark. It may be defined as a Kapha-Vataja disease of Pranavahashrotasa, originating from Pitta Sthana, in which there is derangement of Prana Vayu, along with obstruction by Kapha; the vitiated Vayu attains Pratilomgati and the respiration is disturbed with feeling of tightness of chest, choking of neck or feeling of merging in darkness. It is analogous to Bronchial Asthma due to similarity in symptoms, pathogenesis, onset, causes and precipitating factors. Bronchial Asthma is characterized by chronic airway inflammation and increased airway responsiveness resulting in symptoms of wheeze, cough, chest tightness and dyspnoea. It is also functionally characterized by the airflow limitations which usually reverse spontaneously or with treatment. Current estimate suggest that 300 million people worldwide suffer from Asthma and an additional 100 million may be diagnosed with Asthma by 2025. According to WHO, by the year 2020, Asthma along with COPD will become the third leading cause of death.  India has estimated 15-20 million asthmatics. The available treatment in modern medical science like Bronchodilators, Steroids even in the form of inhalers have made tremendous success in providing instant or symptomatic relief in Bronchial Asthma. But there is recurrent acute exacerbation with remissions and treatment has many side effects like nausea, vomiting, tremor and huskiness of voice. So, need of time is to go for herbal remedies and procedures which not only treat the above ailment but are cost effective, safe and reduces the episodes of relapse of the disease. Keeping this fact in mind, the clinical trial is proposed. A number of formulations have been mentioned in Ayurvedic classics for the treatment of Tamaka Shwasa. Vata and Kapha are the predominant Doshas involved in the pathogenesis of Tamaka Shwasa. The treatment must be of Vatahara and Kaphahara line along with the clearing of the passage of Pranavaha Srotas. Therefore, the drugs with the above said qualities are needed for relieving the symptoms of Tamaka Shwasa. Keeping all above points in mind, the two compound drugs Shunthyadi Churna and Parnasapanchaka Kwatha have been selected to know their effect in treating Tamaka Shwasa (Bronchial Asthma). The drugs are to be administered orally, so does not require any specific instrument or training as in case of inhalers and nebulizers. The contents of the drugs are cheap and easily available so the treatment cost is minimal and can be afforded even by poor patients.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • 1.Patient willing to give informed consent to participate for 30 days.
  • 2.Patients of either sex with age between 18 to 60 years.
  • 3.Patient with stable Bronchial Asthma (Tamaka Shwasa) (as per WHO GINA Guideline) for at least 6 weeks prior to trial.
  • 4.Patient presents with signs & symptoms of Tamaka Shwasa (Bronchial Asthma) as mentioned in Ayurvedic and modern texts.

排除标准

  • 1.Patients with severe Bronchial Asthma.
  • 2.Patients present with co-morbid disorders.
  • (D.M., T.B., R.A., Carcinoma etc.).
  • 3.Patients suffering from pulmonary diseases other than bronchial asthma like COPD, Pleural effusion, Pneumonia.
  • 4.Patients with poorly controlled Hypertension (i.e. Systolic > 160 mm of Hg and Diastolic > 100 mm of Hg) 5.Patients with concurrent serious Hepatic disorder or Renal Disorders, severe Pulmonary Dysfunction, or any other systemic/serious complications like Cerebrovascular / Cardiovascular disease that may jeopardize the study.
  • 6.H/o hypersensitivity to the trial drug or any of its ingredients.
  • 7.Patients who have completed participation in any other clinical trial during the past six months.
  • 8.Pregnancy or lactating women.
  • 9.Any other condition which the Investigator thinks may jeopardize the study.

结局指标

主要结局

Patients of either sex 18-60 yr old diagnosed with tamaka shwasa (Bronchial asthma) will be selected for relief in sign and symptoms

时间窗: 30 days

次要结局

  • Assess comparative efficacy of shunthyadi churna and parnasapanchaka kwatha in tamaka shwasa (Bronchial asthma)(30 days)

研究者

发起方
National Institute of Ayurved
申办方类型
Government medical college

研究点 (1)

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