A clinical study to evaluate effects of herbal medicine (Shirishadi Agad) and ayurvedic procedure (Virechana Karma) in treatment of Santamaka Shwasa (allergic asthma).
- Conditions
- Health Condition 1: J454- Moderate persistent asthma
- Registration Number
- CTRI/2019/04/018405
- Lead Sponsor
- All India Institute of Ayurveda
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Patients of allergic asthma presenting with Tamaka Shwasa lakshna
Total serum IgE concentration greater than or equal to 30 and less than or equal to 700 Intenational units per millilitre at Visit 0
History of at least moderate persistent allergic asthma (consistent with Global Initiative for Asthma [GINA] guidelines of more than 1 year in duration on a stable asthma treatment regimen including inhaled corticosteroids for the preceding 4 weeks
An FEV1 while withholding short acting beta agonists for at least 6 hours and long acting beta agonists for at least 12 hours, of greater than or equal to 75 percentage of the predicted value at Visit 0
Evidence of reversible airway obstruction, as defined by an increase in FEV1 of more than or equal to 12 percentage between 20 to 30 minutes after 4 puffs (or less at the discretion of the investigator) of inhaled short-acting beta-agonist administration at Visit 0 or within the preceding year
Pre-specified level of nocturnal asthma symptoms
Non-smoker for at least 1 year prior to Visit 0, with a smoking history of no more than 10 pack-years (that is 1 pack,20 cigarettes per day for 10 years)
History of intubation for asthma
Asthma exacerbation requiring treatment with systemic steroids within the preceding 3 months
Asthma exacerbation requiring treatment in an emergency department or a hospital admission in the preceding 6 months
Upper respiratory tract infection or sinusitis within the preceding 4 weeks
History of an anaphylactic allergic reaction
History of treatment with immunotherapy to any allergen within past 3 years
History of aspirin or non steroidal anti inflammatory drug (NSAID) related asthma patients could have been included in NSAIDs use was avoided for the duration of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in Doshik Anshansa kalpna (changes in total Asthma symptom score)Timepoint: Thirty days
- Secondary Outcome Measures
Name Time Method Reduction in IgE level. <br/ ><br>Non-allergic response on exposure of allergen. <br/ ><br>Absolute eosinophil count <br/ ><br>Overall Improvement in Quality of life. <br/ ><br>Improvement in Agni Bala, Deha Bala and Chetas Bala as per Ayurveda <br/ ><br>Timepoint: Thirty days