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.

Clinical evaluation of terminalia belerica in diarrhoea.

Terminalia belerica (behada) fruit has been evaluated as a promising agent against E. histolytica and a variety of bacteria associated with dysentery and diarrhoea. These in vitro studies were extended further for evaluating clinical efficacy among patients of acute and chronic cases of diarrhoea and dysentery. The Studies were carried out on 25 patients by five medical practitioners practicing at different clinics in the urban areas of Pune. The data was collected as per the protocol given to the concerned clinicians. Inclusion and exclusion criteria were critically followed. Record of patients' history, clinical evaluations and investigations like stool, urine examination were carried out where necessary.The maximum treatment period was 14 days and the dose was 150 mg. tablets of bioactive fraction three times a day. 11 out of 12 patients responded to therapy and required around twelve tablets for recovery. Seven patients having the presence of cyst of amoeba, E. coli etc. became negative at the end of treatment. Improvement started on second day. No side effects of any nature were observed.

Effect of 'Arogyavardhini' against carbon tetrachloride induced hepatic damage in albino rats.

'Arogyavardhini'-an indigenous formulation was evaluated for its hepatoprotective activity in rats, using two models of carbon tetrachloride (CCl4) hepatic damage, one simulating vital hepatitis and the other simulating fatty change. The protective effect was assessed from serum aspartate transaminase (AST) and alkaline phosphatase levels and from histopathological changes in liver. The results revealed that 'Arogyavardhini' (5 mg/100g, PO daily) was effective in minimizing the changes in serum levels of AST and alkaline phosphatase induced by CCI. The protective effect was also evident on histopathological examination.

Effects of enfenamic acid on renal electrolyte excretion in hypertensive patients.

Single and multiple doses of enfenamic acid were compared in hypertensive patients with those of hydrochlorothiazide using urinary output and electrolytes as parameters. With enfenamic acid, excretion of Na+, K+, and Cl- was significantly decreased in the multiple-dose study; after single doses, there was a significant decrease in the excretion of Na+ and Cl- only.