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Clinical Trials/CTRI/2013/05/003626
CTRI/2013/05/003626Completed未知

Development and clinical evaluation of novel fixed dose combination of rifampicin and isoniazid designed to improve stability and bioavailability of rifampicin for the treatment of tuberculosis.

Department of Pharmaceuticals Ministry of Chemical Fertilizers0 sites100 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
未知
Status
Completed
Sponsor
Enrollment
100
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •Confirmed TB with demonstration of M. Tb. In sputum smear and culture.
  • •Patients with clinical features like cough, fever, anorexia and weight loss.
  • •Chest radiograph compatible with diagnosis of pulmonary TB
  • •Patients willing to give written informed consent.
  • •HIV negative

Exclusion Criteria

  • •Serious form of pulmonary or extra-pulmonary TB (eg. Severe haemoptysis and unconscious patients)
  • •Presence of chronic liver disease and renal insufficiency
  • •Concomitant administration of potential hepatotoxic drugs (eg. methotrexate, phenytoin and valproate)
  • •Chronic alcoholics who consume more than 48 gram of alcohol per day for at least 1 year.
  • •Subjects not willing to participate and continue.
  • •HIV positive

Investigators

Sponsor
Department of Pharmaceuticals Ministry of Chemical Fertilizers

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