A Randomized, Double-blinded, Controlled, Multicentre Phase III Study to Evaluate the Efficacy and Safety of Telmisartan /Amlodipine/Hydrochlorothiazide Compared to Telmisartan/Hydrochlorothiazide in Patients with Essential Hypertension.

OBJECTIVE: Triple drug combination has shown to be effective in controlling blood pressure (BP) with low rates of drug-related side effects. The present study was conducted to compare the efficacy and safety of a triple pill of telmisartan/amlodipine/hydrochlorothiazide (HCTZ) with a dual combination of telmisartan/HCTZ in treating hypertensive patients who did not respond to monotherapies. METHODS: A total of 512 patients were randomized to receive either low-dose triple pill or the dual combination therapy. The primary endpoint was BP normalization after 8 weeks. The secondary endpoints were BP normalization at 4 weeks, changes in BP from baseline to Week 8, comparison of BP normalization between treatment groups, and difference in BP responder rates. The analysis was conducted on the intent-to-treat (ITT), modified intent-to-treat (mITT) and per protocol (PP) population. RESULTS: Statistically significant difference was noted between triple pill and telmi+HCTZ in the normalization of BP at Week 8 in the mITT (p=0.041) and PP (p=0. 038) populations. Also, a statistically significant improvement was observed in BP normalization in triple pill group compared with telmi+HCTZ group in ITT (p=0.022) and mITT (p=0.015) populations after 4 weeks. At Week 8, a significant reduction in BP was seen compared to the baseline in both the treatment groups. There was no statistically significant difference between the two treatment groups in BP normalization. Diastolic BP responder rates were significantly better for triple pill group in PP population (p=0.046). CONCLUSIONS: The triple pill was found to be effective in achieving early normalization of BP in hypertensive patients who did not respond to monotherapies.

Chemoprevention with aqueous extract of Butea monosperma flowers results in normalization of nuclear morphometry and inhibition of a proliferation marker in liver tumors.

Butea monosperma (Lam.) (family: Fabaceae) popularly known as 'Palas' or 'fire of forest' has been used traditionally as a hepatoprotective agent. This study evaluated the hepatoprotective and antitumorigenic properties of the aqueous extract and butanol fractions of B. monosperma flowers in animal models. Dried flowers of B. monosperma were extracted with water and fractionated further using n-butanol. The hepatoprotective activity of the aqueous extract was initially confirmed in a carbon tetrachloride-induced liver damage model of rats. Oral administration of the aqueous extract produced a strong hepatoprotective effect similar to silymarin and normalized the serum levels of ALT, AST, bilirubin and triglyceride in rats. However, it did not affect the levels of glutathione and malondialdehyde which are oxidative stress markers in liver. Intraperitoneal administration of the aqueous extract in the X15-myc oncomice not only maintained liver architecture and nuclear morphometry but also down-regulated the serum VEGF levels. Immunohistochemical staining of liver sections with anti-Ribosomal protein S27a antibody showed post-treatment abolition of this proliferation marker from the tumor tissue. The butanol fractions, however, did not show antitumorigenic activity. Thus, the aqueous extract of B. monosperma flowers is not only hepatoprotective but also antitumorigenic by preserving the nuclear morphometry of the liver.

Effect of bavistin on in vitro plant conversion from encapsulated uninodal microcuttings of micropropagated Bacopa monnieri (L.)--an Ayurvedic herb.

A reliable and reproducible protocol for contamination free plant recovery system from alginated encapsulated uninodal microcuttings of micropropagated Bacopa monnieri L. have been developed after storage at 18 degrees C for 45 days. Node segments excised from freshly micropropagated plants were encapsulated as single explant beads with 3.0% sodium alginate and 80 mM CaCl2 2 H2O. To find out the optimal concentration of fungicide bavistin for efficient plant recovery different concentrations of bavistin (1.0 - 15 mg l(-1)) were incorporated in to the encapsulation medium. 3.0mg l(-1) bavistin showed no reduction in plant conversion and generated maximum number of shoots (45.6 +/- 1.69) at high frequency with out any contamination after storage up to 45 days at 18 degrees C. At high concentrations (13 and 15 mg l(-1)), rupturing of calcium alginate coats after 8 - 9 days and gradual decline in the number of shoots indicates the toxic effect of bavistin on plant conversion. Encapsulated node cuttings stored up to 45 days regenerated shoots (5.2) and multiple shoots (45.6) in MS basal and hormone medium respectively. Maximum shoot length (8.2 +/- 0.37 cm) was observed from encapsulsted node cuttings incorporated with 3.0 mg l(-1) bavistin on MS basal medium. 90% of the recovered plantlets were hardened off and successfully established in soil.