Homeopathy as an Adjuvant to Chemotherapy Improves Clinical Outcome in Relapsed Pulmonary Tuberculosis

Pulmonary Tuberculosis Clinical Trial

Official title:

Homeopathy as an Adjuvant to Chemotherapy Improves Clinical Outcome in Relapsed Pulmonary Tuberculosis: Randomized Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01242592
• Other study ID #: NMP/H/01
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2010
• Last updated: November 16, 2010
• Start date: February 2005
• Est. completion date: June 2008

Study information

• Verified date: November 2010
• Source: NMP Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the effect of homeopathy as an adjuvant to Anti tuberculosis treatment on sputum conversion, hematological, clinical sign and symptoms of relapsed Pulmonary TB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

relapse pulmonary tuberculosis patients with acid-fast bacilli smear positive by microscopy, using ZiehlNieelsen staining as recommended by WHO, unfit for DOTS -

Exclusion Criteria:

pregnancy, clinical sign of any concomitant disease such as diabetes mellitus, acute renal failure or infectious disease including TB/HIV and HIV positive, currently or taken any alternative therapies in past 6 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Drug:
• Anti-Tuberculosis Treatment

Locations

Country	Name	City	State
India	NMP medical Research Institute	Jaipur	Rajastha

Sponsors (1)

Lead Sponsor	Collaborator
NMP Medical Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum conversion	Sputum AFB status by microscopy will be recorded. Sputum conversion is defined as three consecutive sputum smears negative for AFB.		No
Secondary	Quality of Life	Quality of life assessed using SF 36 questionnaire 20 before treatment and after follow up of 11 months. Low numeric scores reflect a perception of poor health, loss of function, and presence of pain		No