Health Condition 1: null- Patients suffering from mild-to-moderate bronchial asthma
Conditions
Interventions
Intervention1: 1. Tab. Swasawin Asthaloc
2. routine anti-asthmatic medications: 1. Tab. Swasawin Asthaloc- 1 tablet twice Daily oral administration
2. routine anti-asthmatic medications ( as prescribe
Sponsors
Ayushakti Ayurved Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects willing to participate in the study and comply with its procedures by signing a written informed consent. 2. Subjects must be between 18 to 70 years of age. 3. Those suffering from mild-to-moderate bronchial asthma (with recurrent symptoms like wheezing, cough which worsens on lying down, dyspnoea and chest tightness & PEFR or FEV1 [predicted value] between 60-80%) for at least a period of one year 4.Current daily anti-asthmatic medications (inhalers ± oral drugs) should have been constant for at least 4 weeks prior to screening visit 5.Those willing to comply with study procedures in the opinion of the investigator
Exclusion criteria
Exclusion criteria: 1.Subjects suffering from other chronic lung diseases (other than asthma) such as cystic fibrosis, COPD or bronchiectasis. 2.Subjects with severe bronchial asthma (peak expiratory flow rate [PEFR] 3.Those with prolonged remissions (lasting more than a month) 4.Subjects with clinically significant cardiovascular disorders, other infectious diseases, arterial hypertension. 5.Active smokers, defined as the consumption of cigarettes pipes, cigars or any other forms of smoking in any amount within the last 3 months 6.Subjects with pulmonary tuberculosis (confirmed by chest screening) 7.Those who have received any investigational product or participated in a drug research study within a period of 30 days prior to the first dose of study medication 8.Female subjects who are pregnant, nursing or planning a pregnancy during the study 9.Subjects with clinically significant cardiovascular, renal, liver, neurological, neoplastic, hematological, endocrinal, infectious, dermatological, psychiatric disorders or chronic respiratory disease other than asthma 10.History of drug and/or Alcohol abuse 11.Subjects not willing to comply with protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a)Mean difference between the groups in the FEV1 values at the end of treatment b)Mean difference between the groups in the PEFR values at the end of treatmentTimepoint: 0 days, 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Mean change in the FEV1& PEFR values b. Mean change in the Ayurvedic & Asthmatic symptom score c. Mean difference in the requirement of anti-asthmatic treatment between the 2 groups d. Mean difference in the incidence of adverse events between the 2 groups. e. Mean difference in the Breath holding time between the 2 groups f. Mean change in the Patient Global Impression of change and investigator Global Impression of change between the 2 groupsTimepoint: 0 days, 90 days | — |
Countries
India
Contacts
Public ContactDr Renuka Munshi
TN Medical College & BYL Nair Hospital
Outcome results
None listed