Clinical trial for comparing Safety and Efficacy of Bio-enhanced Rifampicin (Risorine) Capsule in Newly Diagnosed Pulmonary Tuberculosis in Adult Patients

An open label, Balanced, Randomized, Active control clinical trial to compare Safety and Efficacy of Risorine Capsule in adult patients with RNTCP Category I Pulmonary Tuberculosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/04/008329

Enrollment

144

Registered

2017-04-11

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- Newly Diagnosed Pulmonary Tuberculosis in Adult Patients

Interventions

Intervention1: Risorine Capsule: Each capsule containing Rifampicin 200mg + Isoniazid 300mg + Piperine 10mg Intervention2: Risorine Capsule: One capsule of Risorine contains Rifampicin 200mg + Isoniaz

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18 to 65 years of age 2. Either sex 3. Weight below 60 kg 4. Patients with first time diagnosed of pulmonary tuberculosis that are sputum positive and have radiological and clinical features 5. Patients who are willing to sign informed consent

Exclusion criteria

Exclusion criteria: 1. Hypersensitive to any of the study drugs 2. Pregnant and lactating females 3. Seriously ill and moribund patients 4. Presence of systemic diseases such as HIV, seizure disorder, diabetes mellitus, congestive heart failure or malignancy 5. Hepatitis B and hepatitis C positive patients 6. Currently receiving cytotoxic therapy, or have received it within the last 3 months 7. Patients of organ transplantation receiving immunosuppressive drugs. 8. Patients on systemic corticosteroids for more than 7 days 9. Patients with abnormal renal function 10. Patients with abnormal hepatic function 11. Patients with abnormal hematologic function 12. Patient unable, in the judgement of investigator, to comply with the treatment regimen 13. Patients unwilling or unable to comply with study procedures 14. Patients with history of alcohol or drug abuse.

Design outcomes

Primary

Measure	Time frame
1. To compare, by treatment group, the proportion of patients with a negative sputum smear examination at 2nd, 4th, 6th and 8th week of treatment initiation and then at 3rd, 4th and 6th months of study 2. To compare the cure rate of the two regimens at 6 months 3. To study the safety and tolerability of Risorine containing anti-tubercular regimenTimepoint: 2nd, 4th, 6th, 8th week and then at 3rd, 4th and 6th months of study	—

Measure

Time frame

1. To compare, by treatment group, the proportion of patients with a negative sputum smear examination at 2nd, 4th, 6th and 8th week of treatment initiation and then at 3rd, 4th and 6th months of study 2. To compare the cure rate of the two regimens at 6 months 3. To study the safety and tolerability of Risorine containing anti-tubercular regimenTimepoint: 2nd, 4th, 6th, 8th week and then at 3rd, 4th and 6th months of study

—

Secondary

Measure	Time frame
1. Compare the clinical symptoms between the two regimens 2. Compare radiological improvement between the two regimensTimepoint: 1st month, 2nd month, 4th month and 6th month of the study	—

Countries

India

Contacts

Public ContactDr Randeep Guleria

All India Institute of Medical Sciences

randeepg@hotmail.com01126593676

Outcome results

None listed

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