Homeopathic treatment of obstructive lung diseases

Phase 3

Completed

Conditions: Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecifiedHealth Condition 2: J449- Chronic obstructive pulmonary disease, unspecifiedHealth Condition 3: null- Chronic Obstructive Pulmonary Diseases (COPD)

Registration Number: CTRI/2018/04/013394

Lead Sponsor: ational Institute of Homoeopathy Ministry of AYUSH Govt of India

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

1. Age 18-65 years

2. Both sexes

3. Suffering from mild to severe form of COPD:

Mild: FEV1 >=80% predicted; FEV1/FVC < 0.7

Moderate: FEV1 50-79% predicted; FEV1/FVC < 0.7

Severe: FEV1 30-49% predicted, FEV1/FVC < 0.7

4. Literate patients; ability to read English or Bengali

5. Providing written informed consent

6. Wash-out phase of conventional or other medications, if any, of 2 weeks prior to enrolment

Exclusion Criteria

1. Patients who are too sick for consultation; e.g. very severe COPD: FEV1/FVC < 0.7 and FEV1 <30% predicted or <50% predicted plus chronic respiratory failure [12]

2. Unwilling to take part and not giving consent to join the study

3. Unable to read patient information sheet

4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life

5. Substance abuse and/or dependence

6. Self-reported immune-compromised state, and

7. Undergoing homeopathic treatment for any chronic disease within last 6 months

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spirometric assessment of FEV1/FVC and FEV1Timepoint: Baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
Clinical COPD Questionnaire (CCQ; Bengali version)Timepoint: Baseline, after 3 months, and after 6 months;COPD Assessment Test (CAT) questionnaire (Bengali version)Timepoint: Baseline, after 3 months, and after 6 months;Frequency of exacerbation (defined as acute worsening of respiratory symptoms that results in additional therapy)Timepoint: 6 months