A Randomized Controlled Trial on Twagadi Leha and Vyaghri Haritaki in Chronic Bronchitis

Phase 4

Conditions: Health Condition 1: J411- Mucopurulent chronic bronchitis

Registration Number: CTRI/2024/08/072384

Lead Sponsor: Dr Mayuri Shingnapurkar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patients of either sex aged between 18 to 60 years.

2. Patients having any of following two or more signs and symptoms of Kaphaja Kasa described in the text –

Kasa (cough), Anga Gaurava, Shirogaurava, Shirashoola (Headache), Kaphasampoorna ura, Nishtheevan (Sputum) & Aruchi (Anorexia).

3. Patient with history of uncomplicated Chronic Bronchitis.

4. Patients having PEFR = 50% of the predicted value.

5. Patients willing and able to participate in the study for 12 weeks.

Exclusion Criteria

1. Patients suffering from Acute Bronchitis. 2. Patients having PEFR < 50% of the predicted value. 3. Patients suffering from other pulmonary diseases like Emphysema, Cor pulmonale, Cyanosis, Pneumonia, Cystic fibrosis and major systemic diseases like Rheumatoid arthritis,active Tuberculosis, Cardiac Disorders, CA Lung, AIDS etc. 4. Patients suffering from Diabetes Mellitus. 5. Patients with uncontrolled Hypertension.( >160/100mm of hg) 6. Patients on medication with corticosteroids, bronchodilators, mast cell stabilizers, antidepressants, anti-cholinergic, etc. or any other drugs that may have an influence on the outcome of the study in last 30 days. 7. Patients with viral Hepatitis. 6. Tobacco eaters and/or smokers. 9. Pregnant or lactating women 10. Patients who are not willing to give informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the effect of Twagadi Leha with the help of spirometry parameters.(Peak Expiratory Flow rate and Forced expiratory volume 1) <br/ ><br>2. To find an alternative treatment medicine for Chronic Bronchitis.Timepoint: Day 0, end of 4 weeks, 8 weeks, 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the efficacy of Twagadi Leha in Chronic Bronchitis with respect to improvement in the quality of life with the help of questionnaire. <br/ ><br>Also subjective parameters will be assessed.Timepoint: Assessed on day 0, at the end 4 weeks, 8 weeks & 12 weeks. And at the 0 day, at the end of 8 weeks & 12 weeks respectively.