Back to resultsHomeopathy as an Adjuvant to Chemotherapy Improves Clinical Outcome in Relapsed Pulmonary Tuberculosis
Primary Purpose
Pulmonary Tuberculosis
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Anti-Tuberculosis Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Tuberculosis
Eligibility Criteria
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
Sites / Locations
- NMP medical Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Homeopathy
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Sputum conversion
Sputum AFB status by microscopy will be recorded. Sputum conversion is defined as three consecutive sputum smears negative for AFB.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01242592
First Posted
November 16, 2010
Last Updated
November 16, 2010
Sponsor
NMP Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01242592
Brief Title
Homeopathy as an Adjuvant to Chemotherapy Improves Clinical Outcome in Relapsed Pulmonary Tuberculosis
Official Title
Homeopathy as an Adjuvant to Chemotherapy Improves Clinical Outcome in Relapsed Pulmonary Tuberculosis: Randomized Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
NMP Medical Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Tuberculosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Homeopathy
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Anti-Tuberculosis Treatment
Other Intervention Name(s)
DOT CAT II
Primary Outcome Measure Information:
Title
Sputum conversion
Description
Sputum AFB status by microscopy will be recorded. Sputum conversion is defined as three consecutive sputum smears negative for AFB.
Secondary Outcome Measure Information:
Title
Quality of Life
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
NMP Medical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
NMP medical Research Institute
City
Jaipur
State/Province
Rajastha
Country
India
12. IPD Sharing Statement
Learn more about this trial
Homeopathy as an Adjuvant to Chemotherapy Improves Clinical Outcome in Relapsed Pulmonary Tuberculosis
We'll reach out to this number within 24 hrs