Anti-tubercular activity of aqueous extract of l.inermis leaves and its comparison with ethambutol.

Background: Tuberculosis holds one of the top places on the list of the main cause of death in India. At times the patients fail to respond to treatment with anti tubercular drugs, drug resistance being one of the reasons. The increasing incidence of MDR- and XDR-TB worldwide highlight the urgent need to search for newer anti-tubercular drugs. Objectives: The present study was carried out to assess the antitubercular activity of Lawsonia inermis, and if any, to compare it with ethambutol by "in vitro" method. Materials and Methods: From sputum samples of patients of pulmonary tuberculosis, who had not received any antitubercular drug earlier, the acid-fast bacilli were cultured and identified. Resistance ratio method was followed. For each isolate, (originally from the sputum samples) two sets of L-J slants containing ethambutol, in serially doubling concentration ranging from 1mcg/ml to 16 mcg/ml and L-J slants containing L.inermis leaves aqueous extract (2%) in serial doubling concentration ranging from 3 mcg/ml to 48 mcg/ml were prepared. One set for inoculating with test strain and the other with standard H37Rv strain. Each set had a drug/extract free L-J slant (control). All the L-J slants were labeled with appropriate drug concentrations and incubated at 37° C for 8 weeks for growth. Result & Conclusion: The MIC for ethambutol for both test as well as standard H37Rv strain was 4 mcg/ml by Resistance ratio method. The number of colonies (test and standard H37Rv) on all the L-J slants containing L.inermis extract were more than 100. Thus the aqueous extract of L.inermis leaves used, did not show antitubercular activity in the concentrations of 3 to 48 mcg/ml in the Lowenstein – Jenson media in the present laboratory set up. It is suggested that further studies may be undertaken to confirm the results of the present study.

Efficacy of stimuliv, an indigenous compound formulation, against hepatotoxicity of antitubercular drugs--a double blind study.

Anti-tubercular drugs are known to cause hepatotoxicity, which may lead to noncompliance to drug therapy. Stimuliv, an indigenous compound formulation, is reported to be useful in liver disorders. Efficacy of prophylactic administration of stimuliv against anti-tubercular drugs-induced hepatotoxicity was studied in this double blind randomized clinical trial. One hundred and forty-five newly diagnosed patients of tuberculosis were included in the study. Out of these, sixty three patients were treated with stimuliv (2 tablets thrice daily), sixty received the placebo, while twenty-two dropped out of the study. The patients were assessed clinically and biochemically at two-week intervals over a period of two months. In stimuliv-treated group, the incidence and severity of hepatotoxicity was significantly less (p < 0.05) as compared to placebo-treated group. In addition, patients treated with stimuliv had better appetite and weight gain. Stimuliv treatment may be recommended in newly diagnosed adult patients of tuberculosis.

Comparison of bioavailability and pharmacodynamics of diltiazem from two pharmaceutical preparations.

Diltiazem, a calcium channel blocker, is used in multiple divided doses daily, due to its short elimination half-life. Hence, administration as a modified release (MR) formulation is suggested. In this double blind cross-over trial, the pharmacokinetics and pharmacodynamics of diltiazem was studied in eight healthy Indian adults. Diltiazem was administered as single dose (60 mg) of the two formulations viz immediate release (IR) and MR. Venous blood samples, for estimation of diltiazem by HPLC, were collected at frequent intervals and BP, HR and ECG were monitored during the 12h study period. With MR formulation, plasma half-life was significantly (P < 0.05) prolonged (6.25 +/- 1.2 h vs. 2.69 +/- 0.2 h), the extent of alterations in BP, HR and PR interval was significantly less, while the duration of prolongation of PR interval was significantly more as compared to IR formulation. Therefore, MR formulation of diltiazem has better pharmacokinetic and pharmacodynamic profile as compared to IR formulation.