Comparative Efficacy and Safety of Clonazepam versus Nortrptilline on Menopausal Symptom among Forty Plus Women: A Prospective, Open-Label Randomized Study.

Aims And Objectives: The aim of this study is to compare the effect of clonazepam and nortryptiline on menopausal symptoms in above 40 years women.

Materials And Methods: A prospective, randomized, open-label comparative study was conducted in a tertiary care teaching hospital for 1 year. Patients were randomized into two groups.

Comparative Efficacy and Safety of Clonazepam versus Nortriptyline in Restless Leg Syndrome among Forty Plus Women: A Prospective, Open-Label Randomized Study.

Aims And Objectives: The aim of this study is to compare the effect of clonazepam and nortriptyline on rate, frequency, and severity of restless leg syndrome (RLS) in above 40 years women suffering from RLS.

Materials And Methods: A prospective, randomized, open-label comparative study was conducted at a tertiary care teaching hospital for 1 year. Restless legs syndrome (RLS) diagnosis was based on four essential clinical criteria established by the International RLS Study Group in 2003.

A Prospective, Randomized, Open-Label Study Comparing the Efficacy and Safety of Clonazepam versus Nortriptyline on Quality of Life in 40+ Years old Women Presenting with Restless Leg Syndrome.

Introduction: Restless legs syndrome (RLS) is a neurological disorder characterized by an urge to move the legs usually accompanied by unpleasant leg sensations. RLS also impacts health related quality of life (QOL) in patients suffering from it. Further, it affects women more than men.

Zidovudine-induced nail hyper-pigmentation in 45-year-old women prescribed for HIV/tuberculosis co-infection.

Zidovudine is an important component of first-line antiretroviral treatment regimens used to manage HIV and tuberculosis (TB) co-infection. Nail pigmentation is documented both in adult as well as pediatric HIV patients, but to the best of our knowledge, it has not been reported in 45-year-old women of HIV/TB co-infection. Such an adverse drugs reactions (ADR), although is harmless and reversible, psychological aspects of such ADR may be immense to the extent that it can negatively affect the compliance and result in therapeutic failure.

Bleomycin Containing Chemotherapeutic Regimen Induced Acquired Partial Lipodystrophy.

Bleomycin toxicity predominantly affects the skin and lungs. Cutaneous toxicity classically known to present with bleomycin are flagellate erythema and drug rash. We hereby report an isolated case of (bleomyicn)-induced acquired partial (lipodytrophy) having potential cosmetic implications in a young women prescribed postoperatively following a case of germ cell carcinoma of ovary (endodermal sinus tumor).

Adverse Drug Reaction Profile in Patients on Anti-tubercular Treatment Alone and in Combination with Highly Active Antiretroviral Therapy.

Background And Objectives: Adverse drug reactions are very common among patients on anti-tubercular treatment alone or in combination with highly active antiretroviral therapy but comparatively studied very less. Hence, the current study was done to evalaute the adverse drug reaction (ADR) profile in patients receiving anti-tubercular treatment (ATT) and ATT with highly active antiretroviral therapy (HAART).

Materials And Methods: A one year prospective, cross-sectional observational study was undertaken using suspected adverse drug data collection form available under Pharmacovigilance Programme of India.

Upper gastrointestinal bleed in a post menopausal woman due to combination of high first dose aspirin and clopidogrel prescribed for acute coronary syndrome.

Combination of aspirin, clopidogrel and enoxaparin remains the standard treatment for acute coronary syndrome (ACS) but is known to increase the incidence of upper gastrointestinal bleed (UGIB). We hereby report an unusual case of gastrointestinal bleed (GIB) as it resulted inspite of proton pump inhibitor (PPI) prophylaxis within the second day of treatment in a post-menopausal woman (PMW) with high first dose of aspirin clopidogrel dual combination in a patient of ACS.

Drug-induced diseases (DIDs): An experience of a tertiary care teaching hospital from India.

Background & Objectives: Drug-induced diseases (DIDs) are well known but least studied. Data on DIDs from India are not available. Hence, this retrospective cross-sectional study was undertaken using suspected adverse drug reaction (ADR) data collected form Pharmacovigilance Programme of India (PvPI) to evaluate profile of DIDs over two years, in a tertiary care teaching hospital from north India.

Comparative evaluation of efficacy and safety of combination of metformin-vidagliptin versus metfromin-glimepiride in most frequently used doses in patients of type 2 diabetes mellitus with inadequately controlled metformin monotherapy-A randomised open label study.

Aim And Objective: The aim was to evaluate and compare the efficacy and safety of combinations of metformin-vidagliptin (MF-VG) and metfromin-glimepiride (MF-GP) in type 2 diabetes mellitus (T2DM) patients.

Materials And Methods: A comparative randomized open-label trial was conducted on patients with uncomplicated T2DM, on treatment with MF for 4 months out of which on maximum tolerated dose of MF (1000-2500 mg/day) for 4 weeks, glycosylated Haemoglobin [HbA1c]) ≥6.5%, fasting blood glucose (FBG) ≥126 mg/dl and post prandial glucose (PPG) ≥200 mg/dl were included in the study.

Cycloserine induced psychosis with hepatic dysfunction.

With the increase in the cases of multidrug resistance tuberculosis, second line anti-tubercular drugs like the cycloserine are being prescribed frequently. Isoniazid and ethambutol are reported to cause psychosis like state; however, few reports of cycloserine induced psychosis are available. To the best of our knowledge, this is the first case of cycloserine induced psychosis with hepatic dysfunction.

Under-reporting of adverse drug reactions: a challenge for pharmacovigilance in India.

Aim: The aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India.

Materials And Methods: A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR of ADRs in pharmacovigilance.

Results: At the time, this report was prepared, 90 ADR Monitoring Centers (AMC) were operational in India.

To evaluate efficacy and safety of Caralluma fimbriata in overweight and obese patients: A randomized, single blinded, placebo control trial.

Aim: The aim of the following study is to evaluate the efficacy and safety of Caralluma fimbriata extract (CFE) in overweight and obese individuals in a prospective, randomized, placebo controlled trial.

Materials And Methods: Commercially available CFE was assessed in overweight and obese individuals. A total of 89 patients were randomized into a treatment group (n = 47) and placebo group (n = 42) to receive either CFE in the form capsules/oral 500 mg b.

First Indian study evaluating role of biochemical investigations and diagnostic tools in detection of adverse drug reactions.

Aim Of Study: To evaluate the role of biochemical investigations (BI) and diagnostic tools (DT) in ADR detection.

Materials And Methods: An observational prospective cross-sectional study was done using suspected ADR data collection form.

Results: A total of 2381 ADR related events were recorded in two years.

Prevalence of vitamin d deficiency among Indian menopausal women and its correlation with diabetes: A first Indian cross sectional data.

Aim And Objective: To evaluate prevalence of Vitamin D deficiency and establish any correlation between diabetes and vitamin D deficiency among postmenopausal women.

Materials And Methods: The 25-hydroxy vitamin D [25 (OH) D] concentrations were measured by competitive in-vitro quantitative immunoassay. The subjects were classified as vitamin D-deficient, insufficient or sufficient on the basis of 25 (OH) D concentrations of < 20 ng/mL, 20-30 ng/mL or > 30 ng/mL respectively.

Comparative efficacy and safety of triple therapy (ramipril, telmisartan, hydrochlorothiazide) vs dual anti hypertensive therapy (ramipril or telmisartan, hydrochlorothiazide) in stage 2 hypertensive patients.

Aim: To evaluate the comparative efficacy and safety of ramipril 5mg plus hydrochlorothiazide 12.5mg (R + HCTZ), telmisartan 40mg plus hydrochlorothiazide12.5mg (T + HCTZ) and ramipril 2.

Gastrointestinal bleed induced by a fixed dose combination of rabeprazole and diclofenac sodium.

Non-steroidal anti-inflammatory drugs (NSAIDs) are known to cause gastrointestinal (GI) bleed. Co-administration of proton pump inhibitors (PPIs) has been widely suggested as one of the strategies to prevent these GI complications among NSAIDs users. Herein, we present a case of severe GI bleeding in a patient taking fixed dose combination (FDC) of rabeprazole (20 mg) and diclofenac sodium (100 SR).

Comparative evaluation of aliskiren, ramipril, and losartan on psychomotor performance in healthy volunteers: A preliminary report.

Aim: To compare the effects of aliskiren, ramipril, and losartan on the psychomotor performance in healthy volunteers.

Materials And Methods: In this preliminary, single-dose, open-label, cross-over study conducted in 12 healthy volunteers, psychomotor assessment was carried out by four tests: Simple reaction time (SRT), multiple choice reaction time test (MCRT), critical flicker fusion frequency threshold test (CFFT), and tracking performance test (TPT). Each volunteer received a single dose of each of the three test drugs with a washout period of 10 days between different test sessions and then evaluated for post-drug scores at 2-h intervals up to 12 h and then at 24 h.

Angioedema due to fixed dose combination of telmisartan plus ramipril.

The risk for angioedema has been suggested lower with angiotensin receptor blockers (ARBs) than with angiotensin-converting enzyme inhibitors (ACEIs) or aliskiren. Many isolated reports do exist, reporting angioedema with ARBs such as olmesartan, valsartan, losartan and telmisartan. To the best of our knowledge this is the first case report of telmisartan plus ramipril fixed dose combination leading to angioedema from India questioning the rationality of ARBs plus ACEIs combination in the treatment of hypertension.

Cilnidipine induced ankle edema.

Cilnidipine is a 4(th) generation dihydropyridine calcium channel blocker approved recently for the treatment of essential hypertension. It is not known to present with ankle edema like amlodipine. Moreover, it has been proposed as an alternative anti-hypertensive for patients with amlodipine-induced edema.

Antihypertensive drug prescription patterns, rationality, and adherence to Joint National Committee-7 hypertension treatment guidelines among Indian postmenopausal women.

Aim Of Study: The aim of this study is to evaluate antihypertensive drug prescription patterns, rationality and adherence to Joint National Committee (JNC-7) hypertension (HT) treatment recommendations among Indian postmenopausal women (PMW).

Materials And Methods: An observational and cross-sectional prospective prescription audit study was carried over a period of 1 year. A total of 500 prescriptions prescribed to PMW for diagnosed HT, were identified for one point analysis.

Fatal adverse drug reactions: Experience of adverse drug reactions in a tertiary care teaching hospital of North India - A case series.

Medical burden of fatal adverse drug reactions (FADRs) is significant. The epidemiological data on FADR do exist from the western world, but there is scanty from India. We hereby report a case series of FADRs recorded in a 2 years period.

Effect of Carum carvi, a herbal bioenhancer on pharmacokinetics of antitubercular drugs: A study in healthy human volunteers.

Aim And Objectives: The present study was undertaken in 20 healthy human volunteers to evaluate the effect of a herbal bioenhancer, Carum carvi on pharmacokinetics of rifampicin, isoniazid, and pyrazinamide in fixed dose combination (FDC).

Materials And Methods: It was a prospective, two-period, open-label, cross-over experiment on 20 healthy human male volunteers. The volunteers were administered a single dose of FDC containing rifampicin (450 mg), isoniazid (300 mg), and pyrazinamide (1000 mg) and after 10 days washout period the same FDC along with C.

First Indian prospective randomized comparative study evaluating adherence and compliance of postmenopausal osteoporotic patients for daily alendronate, weekly risedronate and monthly ibandronate regimens of bisphosphonates.

Aim: The aim of the following study is to evaluate adherence and compliance of postmenopausal osteoporotic patients for different regimens of bisphosphonates (BP).

Materials And Methods: A prospective observational randomized comparative 1 year study was undertaken to evaluate the adherence/compliance rates of most commonly prescribed daily alendronate (ALN), weekly risedronate (RIS) and monthly ibandronate (IBN) BP regimens.

Results: Nearly 40% was the 1 year adherence rate with BP and 41.