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

This study has been completed.
Sponsor:
Information provided by:
NMP Medical Research Institute
ClinicalTrials.gov Identifier:
NCT01242592
First received: November 16, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Pulmonary Tuberculosis
Drug: Anti-Tuberculosis Treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Homeopathy as an Adjuvant to Chemotherapy Improves Clinical Outcome in Relapsed Pulmonary Tuberculosis: Randomized Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by NMP Medical Research Institute:

Primary Outcome Measures:
  • Sputum conversion [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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


Enrollment: 56
Study Start Date: February 2005
Estimated Study Completion Date: June 2008
Arms Assigned Interventions
Experimental: Homeopathy Drug: Anti-Tuberculosis Treatment
Other Name: DOT CAT II
Placebo Comparator: Placebo Drug: Anti-Tuberculosis Treatment
Other Name: DOT CAT II

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01242592

Locations
India
NMP medical Research Institute
Jaipur, Rajastha, India
Sponsors and Collaborators
NMP Medical Research Institute
Investigators
Principal Investigator: Neha Sharma, PhD NMP Medical Research Institute
  More Information

No publications provided

Responsible Party: Dr Neha Sharma, NMP Medical Research Institute
ClinicalTrials.gov Identifier: NCT01242592     History of Changes
Other Study ID Numbers: NMP/H/01
Study First Received: November 16, 2010
Last Updated: November 16, 2010
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Lung Diseases
Mycobacterium Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014