An Open Labelled Randomized Controlled Clinical Study to Evaluate The Efficacy of Devdarvyadi Churna and Vyaghri Churna in Management of Kaphaja Kasa W.S.R. to Chronic Bronchitis.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- To assess the Anti-inflammatory and expectorant effect of Devdarvyadi Churna in comparison with Vyaghri Churna in the management of Kaphaja Kasa on the basis of ESR, AEC.
Study Overview
Brief Summary
In recent years, there has been a notable rise in respiratory diseases. According to the National Center for Health Statistics, 62 million cases of common cold and cough occur annually, and cough ranks as the fifth most common symptom for which medical care is sought. Chronic bronchitis affects about 9.5 million people, primarily those over 50 years old. In Ayurveda, Kasa (cough) is described as a disease, symptom, or complication. Kaphaja Kasa, a type of Ardra Kasa, is dominated by Kapha and Vata involvement and is comparable to chronic bronchitis due to similarities in symptoms like persistent productive cough. Chronic bronchitis involves inflammation of bronchi with sputum production for at least three months over two consecutive years and is linked to pollutants, smoking, and infections. If untreated, Kasa can lead to serious conditions like Shwasa (asthma) or Rajyakshma (tuberculosis). The Devdarvyadi Churna, mentioned by Acharya Charaka, contains herbs like Devdaru, Haritaki, Musta, and Pippali along with Madhu (honey), which help in pacifying Kapha and regulating Vata. With Ushna Veerya, Deepana, and Pachana properties, this formulation aids in digestion and relieves cough. Hence, this study aims to evaluate its efficacy in managing Kaphaja Kasa.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 30.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Chronicity From 3 months to 2 Consecutive Years Patients having symptoms of Chronic Bronchitis copious and purulent sputum and frequent episodes of respiratory insufficiency Patient willing to sign the informed consent and can participate in the study procedure Patients having FEV1 between 50% to 80%.
Exclusion Criteria
- •Pregnant or lactating women.
- •Immunocompromised status such as HIV, Tuberculosis, Cancer etc.
- •History of upper or lower respiratory tract infection, within the previous 30 days.
- •Subjects suffering from Acute Bronchitis.
- •K/C/O pneumonia, plural effusion, pneumothorax, heart disease, secondary severe infection.
- •Patients with uncontrolled Hypertension and uncontrolled Diabetes.
Outcomes
Primary Outcomes
To assess the Anti-inflammatory and expectorant effect of Devdarvyadi Churna in comparison with Vyaghri Churna in the management of Kaphaja Kasa on the basis of ESR, AEC.
Time Frame: 2 Months
Secondary Outcomes
- To assess the Anti-inflammatory & expectorant effect of Devdarvyadi Churna in comparison with Vyaghri Churna in the management of Kaphaja Kasa on the basis of Spirometry, SGRQ.(2 Months)