A Comparative study to Evaluate Efficacy of "Shwasa Kuthar Rasa" and "Pippali Vardhman Rasayan" in the management of Chronic Obstructive Pulmonary Disease(Praanavaha Sroto Dushti)
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 2)Improvement in SGRQ(St. George’s Respiratory Questionnaire) score
Study Overview
Brief Summary
COPD is a disease state characterised by progressive development of chronic airflow limitation caused by chronic inflammation of airways and lung parenchyma .It leads to gradual decline in the lung function and worsening of dyspnoea and health status . Ciggarette smoking and occupational smoke produces free radicals which in turn irritates mucus glands causing over secretions of mucus. This causes irritation of airways leading to inflammation which ultimately lead to obstruction in airflow due to narrowing of pathways. Thus the poor Thoraco-Abdominal respiration due to COPD needs a safe , cost effective , easy to administer, evidence based treatment which not only combat with the signs and symptoms of the disease but also uproot the basic pathology which has occured in due course of time without any adverse effects. In modern sciences treatment of COPD includes Bronchodialators, Corticosteroids, Antibiotics and Oxygen Supplimentation.But in this trial comparative study of Shwasa Kuthar Rasa and Pippali Vardhman Rasayan has been selected(Ayurvedic Medicines). If Pippali Vardhman Rasayan proves effective and safe in treatment of COPD it would enable us to formulate a new treatment regimen which would not only be of shorter duration but also be economical and affordable to the economically deprived masses around the globe. It will also allay the fears of the side effects of treatment regimen followed in COPD.It may also prove helpful to great extent in the prevention of extensive drug resistance and multi drug resistance . It may also be used as cost effective, easily available and quite affordable alternative treatment for the patients suffering from COPD.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 35.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Age Group between 35-65 years.
- •Patients of Both Sexes.
- •Smoking history current or former active ciggarette smokers or history of occupational exposure to COPD.
- •4.Patients present with signs and symptoms of COPD.
- •5.Radiographic evidence suggestive of COPD.
- •6.Spiro-metric diagnosis of COPD(as per GOLD criteria)
- •The patients who are ready to sign informed consent form to participate in study.
- •The patients who are ready to be consistent in visits during whole trial period.
- •Firm home address and contact number which is readily accessible during whole course of trial.
Exclusion Criteria
- •Seriously ill and morbid patients which are unlikely to survive for next 6 months.
- •Pregnant and lactating women 3)Patient with alcohol dependence 4)History of hypersensitivity to any of trial drug 5)Patient with serious hepatic disorder, renal disorder, diabetes mellitus or any condition that may jeopardize the study 6)Patient with any other concomitant respiratory disorder 7)Patient with co-morbid disorders(Diabetes Mellitus, Pulmonary Tuberculosis ,Rheumatoid Arthritis , Carcinoma) 8)Patient with poorly controlled hypertension (systolic >160 mmHg and diastolic > 100 mmHg) 9) Patient receiving mast cell stabilizers, anti-depressants, anticholinergics etc.
- •or any other drugs that may have an influence on the outcome of the study.
Outcomes
Primary Outcomes
2)Improvement in SGRQ(St. George’s Respiratory Questionnaire) score
Time Frame: Every 7 days
1)Improvement in BODE index(Body mass index, Obstruction, Dyspnoea, Exercise endurance) score
Time Frame: Every 7 days
3)Improvement in severity of clinical symptoms of Praanavaha Sroto Dushti.
Time Frame: Every 7 days
Secondary Outcomes
- 1)Improvement in Forced Expiratory Volume in 1 second (FEV1) pre and post bronchodilator intake.(2)Improvement in FEV1/FVC ratio pre and post bronchodilator intake)