Health Condition 1: K590- Constipation Health Condition 2: J454- Moderate persistent asthma
Conditions
Interventions
None listed
Sponsors
All India Institute Of Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of all genders between 21 and 60 years. 2.Patients having classical features of Santamaka shwasa as well as Udavarta. A history of variable respiratory symptoms including wheeze, shortness of breath, chest tightness and cough. 3.Positive Reversibility Test: Evidence of reversible airway obstruction, as defined by an increase in FEV1 of greater than 200ml or greater than or equal to 12 percent of the pre-bronchodilator value 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. 4.FEV1/FVC ratio is less than 80 percent of predictive value. Severity as Mild to Moderate stable asthma defined as FEV1 between 60 percent to 80 percent of the predicted value. 5.Total serum IgE concentration greater than or equal to 130 and less than or equal to 700 IU/mL at Visit 0. 6.Patients presenting with functional constipation diagnosed as per ROME IV criteria. 7.Patients eligible for Virechana Karma. 8.Patients who are willing to participate in the study with informed written consent.
Exclusion criteria
Exclusion criteria: 1.Evidence of active concomitant pulmonary diseases other than asthma like TB, pneumonia, etc. 2.Patients taking steroid therapy (systemic or inhaled). 3.Concomitant severe systemic disease (cardiovascular, renal, hepatic, endocrine, haematological, neurological, immunological). 4.Diagnosed cases of Hypothyroidism and Irritable bowel syndrome. 5.Patients with uncontrolled Type 2 Diabetes mellitus (HbA1c greater than 7 percent), Grade 2 Hypertension or more. 6.Past or current malignancy. 7.Pregnant ladies and lactating mothers. 8.History of any adverse drug reactions to any ingredient of the drug. 9.Patients having positive HIV1 and 2 or positive Hepatitis B. 10.Patients on medications such as antacids/iron supplements/laxatives/NSAIDS/Anti histamines/diuretics/anti psychotics. 11.Patients who participated in other clinical trials in past 12 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FEV1, FEV1/FVC, FVC & PEFR.Timepoint: Assessment of signs and symptoms at baseline, after Virechana, after rasayana and after follow up of 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the sign and symptoms of Santamaka Shwasa and udavarta. Change in IgE level and AEC level. Change in Constipation Assessment Score- Wexner constipation score & Patient s Assessment of Constipation Symptoms questionnaire Score. Change in Modified Medical Research Council (mMRC) dyspnoea scale.Timepoint: Assessment of signs and symptoms at baseline, after Virechana, after rasayana and after follow up of 1 month | — |
Countries
India
Contacts
Public ContactDr Haritha T
All India Institute Of Ayurveda
Outcome results
None listed