Role of Risorine in the Treatment of Drug - Susceptible Pulmonary Tuberculosis: A Pilot Study.
OBJECTIVE
To study the efficacy and tolerability of Risorine Capsule (A fixed dose combination of Rifampicin 200 mg + INH 300 mg + Piperine 10 mg) therapy in the treatment of drug-susceptible pulmonary tuberculosis patients who developed GI intolerance with standard WHO anti TB regimen.


METHODS
33 patients with pulmonary tuberculosis were treated with one Risorine kit, daily consisting of one capsule of Risorine, one tablet of ethambutol (800 mg) and two tablets of Pyrazinamide 750 mg each, for first two months of therapy. All the patients received one capsule of Risorine daily for next four months. Symptomatic improvement, Sputum conversion and radiological improvement were monitored at regular intervals.


RESULTS
Out of 27 patients who were sputum positive at baseline, 24 patients became sputum negative during the first two months of treatment. Out remaining three patients, one became sputum negative at the end of third month of treatment and the other two became sputum negative at the end of sixth month of treatment. Out of 33 patients, only two patients developed mild nausea, which subsided spontaneously. One patient who was HIV positive, developed hepatitis.


CONCLUSIONS
Risorine, a novel formulation of rifampicin 200 mg with bioenhancer piperine 10mg, is found to be highly effective and well tolerated in the treatment of drug - susceptible pulmonary tuberculosis.
Asst. Hon. and In Charge, Dept. of Chest and TB, Dr. R. N. Cooper Muni. Gen. Hospital, Mumbai and Prof., Dept of Chest and TB, KJ Somaiya Medical College, Mumbai, Maharashtra.
Agam
A
Vora
Medical Department, CPL, Ahmedabad, Gujarat.
Sanjay
S
Patel
Medical Department, CPL, Ahmedabad, Gujarat.
Kamlesh
K
Patel
D000328:Adult; D000470:Alkaloids / Q000008:administration & dosage; D000995:Antitubercular Agents / Q000008:administration & dosage*; D052117:Benzodioxoles / Q000008:administration & dosage; D065607:Cytochrome P-450 Enzyme Inhibitors / Q000008:administration & dosage; D004338:Drug Combinations; D004977:Ethambutol / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007538:Isoniazid / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010880:Piperidines / Q000008:administration & dosage; D053284:Polyunsaturated Alkamides / Q000008:administration & dosage; D011718:Pyrazinamide / Q000008:administration & dosage; D012293:Rifampin / Q000008:administration & dosage; D014397:Tuberculosis, Pulmonary / Q000188:drug therapy*; D055815:Young Adult
D000470:Alkaloids; D000995:Antitubercular Agents; D052117:Benzodioxoles; D065607:Cytochrome P-450 Enzyme Inhibitors; D004338:Drug Combinations; D010880:Piperidines; D053284:Polyunsaturated Alkamides; D011718:Pyrazinamide; D004977:Ethambutol; C008922:piperine; D007538:Isoniazid; D012293:Rifampin