CTRI/2018/04/013394
Completed
Phase 3
Evaluating the effectiveness of adjunctive mother tinctures to individualized homeopathic treatment of chronic obstructive pulmonary diseases: an open randomized pragmatic trial
ational Institute of Homoeopathy Ministry of AYUSH Govt of India0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- 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)
- Sponsor
- ational Institute of Homoeopathy Ministry of AYUSH Govt of India
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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