NCT01242592

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2010

Completed
Last Updated

November 17, 2010

Status Verified

November 1, 2010

First QC Date

November 16, 2010

Last Update Submit

November 16, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sputum conversion

    Sputum AFB status by microscopy will be recorded. Sputum conversion is defined as three consecutive sputum smears negative for AFB.

Secondary Outcomes (1)

  • Quality of Life

Study Arms (2)

Homeopathy

EXPERIMENTAL
Drug: Anti-Tuberculosis Treatment

Placebo

PLACEBO COMPARATOR
Drug: Anti-Tuberculosis Treatment

Interventions

Also known as: DOT CAT II
HomeopathyPlacebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMP medical Research Institute

Jaipur, Rajastha, India

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Neha Sharma, PhD

    NMP Medical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 17, 2010

Study Start

February 1, 2005

Study Completion

June 1, 2008

Last Updated

November 17, 2010

Record last verified: 2010-11

Locations