Health Condition 1: J40-J47- Chronic lower respiratory diseases
Conditions
Interventions
None listed
Sponsors
Central Council for Research in Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participant of either gender aged 20 to 60 years and working in the incense stick industry. 2. Participants with a productive cough for at least 3 months per year for two consecutive years. 3. FEV1 more than 80 percent of the predicted value. 4. Participants who are cognitively aware and able to express their opinions. 5. Participants who are willing to participate and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Participant with known cases of other respiratory diseases, including bronchial asthma, pulmonary tuberculosis, bronchiectasis, interstitial lung disease or lung malignancy. 2. Participant with an acute respiratory infection or an acute exacerbation of chronic bronchitis within the last four weeks prior to enrolment. 3. Participants having HbA1C equal to /more than 6.5 % 4. Participants having uncontrolled hypertension (BP greater than or equal to 160/100 mmHg), with or without medication. 5. Patients with a history of any significant cardiovascular or systemic comorbidities, such as a history of coronary artery disease, cardiac arrhythmia, congestive cardiac failure, impaired renal function (serum creatinine more than 1.2 mg/dL), or impaired hepatic function (ALT or AST greater than three times the upper limit of normal). 6. Participants with any neurological disorder or psychiatric illness. 7. Participants unable to take oral medications or with any known malabsorption syndrome. 8. Participants with active substance abuse. 9. Participants currently enrolled in or participating in another clinical trial. 10. Women who are pregnant, lactating, or planning for conception during the study period. 11. Participants with known hypersensitivity or allergy to the trial drug or its components. 12. Participants currently receiving systemic corticosteroid or immunosuppressive therapy. 13. Participants currently using any Ayurvedic therapy for respiratory disorders. 14. Any other condition which the Principal Investigator thinks may jeopardise the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Leicester Cough Questionnaire (LCQ) ScoreTimepoint: Baseline, 30th day, 60th day & 90th day | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in QoL from base line to the end of the treatment assessed using St. Respiratory Questionnaire.Timepoint: Baseline, 30th day, 60th day & 90th day;Change in pulmonary function parameters (FEV1 & PEFR) from baseline to the end of treatment.Timepoint: Baseline, 30th day, 60th day & 90th day;Change in level of inflammatory marker CRP & ESR.Timepoint: Baseline, & 90th day | — |
Countries
India
Contacts
Public ContactDr Ekta
Central council for Research in Ayurvedic Sciences
Outcome results
None listed