Effect of Ayurvedic treatment in COPD

Phase 3

Conditions: Health Condition 1: null- Patients of COPD

Registration Number: CTRI/2018/02/011918

Lead Sponsor: Ch Brahm Prakash Ayurved Charak Sansthan

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Age Group between 35-65 years.

2. Patients of Both Sexes.

3. 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)

7. The patients who are ready to sign informed consent form to participate in study.

8. The patients who are ready to be consistent in visits during whole trial period.

9. Firm home address and contact number which is readily accessible during whole course of trial.

Exclusion Criteria

1)Seriously ill and morbid patients which are unlikely to survive for next 6 months.

2)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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Improvement in BODE index(Body mass index, Obstruction, Dyspnoea, Exercise endurance) score <br/ ><br>2)Improvement in SGRQ(St. Georgeâ??s Respiratory Questionnaire) score <br/ ><br>3)Improvement in severity of clinical symptoms of Praanavaha Sroto Dushti. <br/ ><br>Timepoint: Every 7 days

Secondary Outcome Measures

Name	Time	Method
1)Improvement in Forced Expiratory Volume in 1 second (FEV1) pre and post bronchodilator intake. <br/ ><br>2)Improvement in FEV1/FVC ratio pre and post bronchodilator intake <br/ ><br>3)Reduction in episodes of cough <br/ ><br>4)Reduction in volume of sputum produced <br/ ><br>5)Percentage of patients who acquired lakshanas of karyaphala described in Charaksamhita. <br/ ><br>Timepoint: Every 7 days