Effect of Pushkaramoola Churna with Bharangikanadi Kashaya and Vamana Karma in Management of Tamaka Shwasa with special reference to Bronchial Asthma
- Conditions
- Health Condition 1: J452- Mild intermittent asthmaHealth Condition 2: J453- Mild persistent asthmaHealth Condition 3: J454- Moderate persistent asthmaHealth Condition 4: J459- Other and unspecified asthma
- Registration Number
- CTRI/2024/03/064423
- Lead Sponsor
- Department of Kayachikitsa
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients willing to participate in above trial and given written consent
2.Patient of either sex greater than 20 years and less than 50 years
3.Patient with stable bronchial asthma as per WHO GINA Guidelines for at least 6 weeks prior to study entry.(Episodes of Wheezing, shortness of breath, Chest tightness, and cough, that vary over time and in intensity, together with variable expiratory airflow limitation - GINA definition of Bronchial asthma)
Positive test of reversibility: -
a.Symptomatic patients - an improvement of 60L/min or more than 20% in PEFR, 10 minutes after the inhalation of 200mcg of salbutamol
b.Asymptomatic patients – 60L/min or more than 20% fall in PEFR by provocation with 5-10 minutes of physical exercise, followed by reversal upon inhalation of 200mcg of salbutamol, when assessed after 10 minutes.
4.FEV1 more than 50% and less than 80%
5.FEV1 and FEV ratio less than 70%
6.Patient presenting with features of Tamaka shwasa as in ayurvedic classical text books
1.Patients with PEFR less than 50% and or FEV1 less than 50% of predicted value
2.Pregnant and lactating women
3.Patient with poorly controlled diabetes mellitus (HbA1c greater than 8%)
4.Patient with poorly controlled Hypertension (Systolic greater than 160 mm Hg and Diastolic greater than 100 mm of Hg)
5.Patients on prolonged (more than 6 weeks) medication with corticosteroids, bronchodilators, mast cells stabilizers, antidepressants, anticholinergics, or any other drugs that may have an influence on the outcome of the study.
6.Smoker or alcoholic or drug abusers
7.Patients who have a past history of Atrial fibrillation, Acute Coronary Syndrome, Myocardial Infraction, stroke or severe Arrhythmia in last 6 months
8.Patient having systemic illness necessitating long term drug treatment like TB, carcinoma, endocrine disorders, concurrent major liver or renal disorders, psychological disorders, neurological disorders like epilepsy, meningitis, stroke etc.
9.Patients who have completed participation in any other clinical trial during the past 6 months
10.Patient having pulmonary diseases other than asthma
11.Patient having SPO2 less than 90%
12.Emergency patients requiring O2 inhalation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in subjective criterias; <br/ ><br>1.Asthma Control Test <br/ ><br>2.Reduction signs and symptoms of disease. The main signs and symptoms in study are as follows; <br/ ><br>Frequency of shwasa vega (frequency of breathing difficulty attacks) <br/ ><br>Duration of attack <br/ ><br>Kasam (cough) <br/ ><br>Kapha Nishthivanam (Expectoration) <br/ ><br>Rudhho Ghur-ghurakam (Wheezing) <br/ ><br>Urashoola/Parshvashoola (Pain at the chest region) <br/ ><br>Timepoint: Treatment period – 3 months <br/ ><br> Follow up period – on every 15th day <br/ ><br>
- Secondary Outcome Measures
Name Time Method Changes in following objective criterias; <br/ ><br>1.Pulmonary function test- Spirometry <br/ ><br>a.Forced expiratory volume in 1 second (FEV1) <br/ ><br>b.Forced vital capacity (FVC) <br/ ><br>c.FEV1/FVC <br/ ><br>2.Breath holding time <br/ ><br>3.Hematological investigations <br/ ><br> (CBC, Absolute Eosinophil Count, LFT, RFT)Timepoint: Treatment period – 3 months <br/ ><br>Follow up period – on every 15th day <br/ ><br>