Comparison of sputum conversion rates, plasma rifampicin levels and cyp450 activity pulmonary tuberculosis patients who have received 8 weeks of intensive phase therapy with standard dose regimen versus risorine kit

COMPARISON OF SPUTUM CONVERSION RATES, PLASMA RIFAMPICIN LEVELS AND CYP450 ACTIVITY IN CATEGORY-I SPUTUM POSITIVE PULMONARY TUBERCULOSIS PATIENTS WHO HAVE RECEIVED 8 WEEKS OF INTENSIVE PHASE THERAPY WITH STANDARD DOSE REGIMEN VERSUS RISORINE KIT

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2012/11/003097

Enrollment

100

Registered

2012-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- CATEGORY-I SPUTUM POSITIVE PULMONARY TUBERCULOSIS PATIENTS

Interventions

Intervention1: Risorine Kit: One Risorine capsule ( Rifampicin 200mg + Isoniazid 300mg + Piperine 10mg) + one tablet of Ethambutol 800mg + two tablets of Pyrazinamide 750mg {Therapy for 8 weeks (56 d

Eligibility

Inclusion criteria

Inclusion criteria: • Males/females in the age range of 18-60 years and body weight range of 37-55 kg • Category-I sputum positive pulmonary tuberculosis patients • Willing to give informed consent

Exclusion criteria

Exclusion criteria: • Sputum negative patients • Pregnant or lactating females or females on oral contraceptives • HIV positive patients • Seriously ill and moribund patients • Hemoglobin • Patients with abnormal hepatic function [aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) more than 3 times the upper limit of normal, or serum bilirubin more than 1.5 mg/100ml] • Hypersensitivity to any of the drugs to be administered as part of regimen

Design outcomes

Primary

Measure	Time frame
Sputum conversion rates, Rifampicin level, CYP450 LevelTimepoint: At 1,8,15,28 & 56 days	—

Secondary

Measure	Time frame
NATimepoint: NA	—

Countries

India

Contacts

Public ContactDr Bhaumik Mody

Cadila Pharmaceuticals Limited

ashish.akar@cadilapharma.co.in9925669549

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026