A Risorine study in sputum positive patients after 8 weeks of conventional treatment

TO STUDY EFFECT OF RISORINE THERAPY ON PLASMA RIFAMPICIN LEVELS IN PATIENTS WHO REMAIN SPUTUM POSITIVE AT THE END OF 8 WEEKS OF CONVENTIONAL INTENSIVE PHASE THERAPY

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2012/11/003096

Enrollment

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: A150- Tuberculosis of lung

Interventions

Intervention1: Risorine kit: Risorine capsule (Rifampicin 200mg + Isoniazid 300mg + Piperine 10mg) + one tablet of Ethambutol 800mg + Pyrazinamide 2x750mg tablets Intervention2: Risorine Kit: Once Da

Eligibility

Inclusion criteria

Inclusion criteria: •Males/females in the age range of 18-60 years •Category-I sputum positive pulmonary tuberculosis patients who remain sputum positive at the end of 8 weeks of conventional intensive phase therapy •Compliance to treatment •Willing to give informed consent

Exclusion criteria

Exclusion criteria: •Sputum negative patients •Pregnant or lactating females or females on oral contraceptives •HIV positive status •Seriously ill and moribund patients •Hypersensitivity to any of the drugs to be administered as part of regimen •Treatment noncompliant patients as per treating physician discretion

Design outcomes

Primary

Measure	Time frame
To evaluate effect of one monthâ??s Risorine therapy on plasma rifampicin levels in Category-I sputum positive pulmonary tuberculosis patients who remain sputum positive at the end of 8 weeks of conventional intensive phase therapy (Rifampicin 450mg + Isoniazid 300mg + Ethambutol 800mg + Pyrazinamide 1500 mg, all given once daily).Timepoint: 30 days from randomization	—

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