Evaluation of Hilo® Versus Daflon® in Patients Suffering from Hemorrhoids: A Randomized, Controlled, Open-labelled, Multicentric Study

Aims: To evaluate and compare the efficacy of Hilo® and Daflon® 500 mg, in the treatment of hemorrhoids.Study Design:It is a multicentric, randomized, comparative clinical trial conducted for the period of 15 days.Place and Duration of Study:Janta Hospital and Maternity Centre, Varanasi; King George Memorial Hospital, Lucknow; Vijan Hospital and Research Centre, Nasik and Santosh Hospital, Bangalorebetween May 2018 and December 2019.Methodology:201 patients were screened and 200 patients with hemorrhoids (proctoscopy proven Grade I to III) were randomly assigned to receive either Hilo® capsules (n = 99) or Daflon® 500 mg tablets (n = 101). Assessment of hemorrhoidal symptoms was carried out in all patients on Day 7 and Day 15. Proctoscopic examination was carried out before the start of treatment i.e. on day 0 and at the end of treatment duration i.e. on day 15.Results:The patients treated with Hilo® showed a statistically significant improvement in the clinical symptoms of bleeding, pain, itching, soiling, tenesmus, irritation after defecation and constipation on day 7 and day 15 as compared to baseline. The “mean total symptom score” reduced by 4.55 ± 2.07 vs 3.44 ± 2.00; P < .0001 on day 7and 7.56 ± 2.40 vs 6.22 ± 2.55;P < .0001 on day 15 in thepatients treated with Hilo® and Daflon® respectively. In Hilo® Group, 82.83% of patients assessed that the treatment with Hilo® made them ‘A lot better’ as compared to only 48.51% in Daflon® group. In the Hilo® group 20.2% of patients’ treatment outcome was assessed as ‘Excellent’ by the investigators as compared to only 0.99% of patients in Daflon® group. No major adverse events were reported in the study with the use of either product.Conclusion:Hilo® is found to provide better reduction in clinical symptoms of patients suffering from hemorrhoids as compared to Daflon®

The Clinical Experience of Atosiban in Preterm Labour.

Aims: To evaluate the efficacy, safety and tolerability of atosiban in delaying preterm labour. Study Design: A prospective, open label, non comparative study. Place of Study: Lokmanya Tilak Municipal Medical College Mumbai, India. Methodology: Pregnant women (N=110) between the gestational age of 24 to 34 weeks, presenting with signs of preterm labour were enrolled in the study. Efficacy, safety and tolerability of Atosiban were assessed for a period of 72 hrs. Results: Ninety Eight patients (89.09%) remained undelivered up to 72 hrs after completion of treatment phase and ninety seven patients (88.18%) till the end of their hospital stay (upto 7 days). There were six patients with twin and one with quadruplet pregnancy; atosiban therapy was successful in delaying labour upto discharge from hospital in all the seven patients. The study medication was well tolerated as no adverse events were observed throughout the study duration. Conclusion: Atosiban, an oxytocin receptor antagonist, has proven to be an effective and well tolerated tocolytic drug and because of its favourable safety profile, it may be the best choice as a tocolytic therapy to delay the preterm labour.

Efficacy of Seratrodast, a Thromboxane A2 Receptor Inhibitor in a Double Blind Comparative Clinical Trial with Monteluklast.

Aims: To assess the comparative efficacy, safety and tolerability of seratrodast versus montelukast in controlling mild to moderate asthma in adult patients. Study Design: Randomized, comparative, double blind, double dummy, multi-center, parallel group, non inferiority study. Methods: Patients (n=205) with mild to moderate asthma continuing on the lowest dose of inhaled corticosteroid were recruited from 3 different centers across India. Patients were randomly assigned to receive either seratrodast 80 mg (n=103) or montelukast 10 mg (n=102) once daily for 28 days. The treatments were compared for improvement from the baseline values, as per the changes in asthma symptom score (wheezing, shortness of breath, expectoration, cough and chest tightness), lung function parameters (PEF, FVC and FEV1), sputum and mucociliary parameters [fucose, eosinophil cationic protein (ECP) and albumin]. Results: Seratrodast and montelukast showed improvement in the clinical parameters of asthma as well as in the lung function tests and sputum parameters from baseline. Both the treatments significantly increased mean values of PEF, FVC and FEV1 from the baseline after a 4 week treatment but seratrodast produced significantly greater improvement in PEF (0.416 L/s, P=.01). Moreover, there was significantly more reduction in expectoration score (P=.01), sputum concentrations of ECP (P<.001) and albumin (P<.001) in seratrodast group, signifying improvement in asthma condition. The two treatment groups had similar tolerability profiles. Mild increase in hepatic enzymes was seen in both the groups with no clinical significance. No serious adverse events were observed during the study. Conclusions: Seratrodast, a Thromboxane A2 receptor antagonist, was found to be better in the improvement of PEF, reduction in expectoration, ECP and albumin levels as compared to montelukast. Seratrodast can be recommended as a controller medication in mild to moderate asthma.

An Open-Label, Multicenter Post Marketing Study to Assess the Symptomatic Efficacy and Safety of Troxipide [TroxipTM] in the Management of Acid Peptic Disorders in Indian Patients.

Aims: A post marketing study to assess the symptomatic efficacy and safety of Troxipide (TROXIPTM) 100mg in the management of acid peptic disorders (APDs) in Indian population. Study Design: An observational, prospective, uncontrolled, open-label, multicenter post marketing study. Place and Duration of Study: Patients were enrolled from 62 centers across 11 states of India, between October 2010 and March 2012. Methodology: Out of 1500 APD patients, 1486 (850 men, 636 women; age range 16-85 years) were prescribed Troxipide 100mg tablet orally thrice daily. The efficacy and safety assessments were performed on day 14 and day 28 after beginning the treatment and recorded in the case report forms. The efficacy of Troxipide was estimated based on the changes from the baseline in the symptom score on a 100 point visual analogue scale (VAS) for individual symptoms. Safety was assessed by adverse events reported with usage of Troxipide on day 14 and day 28 after start of the treatment. Results: Troxipide monotherapy (n=1427) significantly reduced the mean VAS score from baseline for all major symptoms, viz. nausea, vomiting, belching, heart burn, epigastric pain, acid regurgitation, abdominal bloating & loss of appetite at the end of the study. The global mean VAS score (a sum of individual symptom VAS score) of these patients decreased from 134.26 ± 75.31 to 21.88 ± 39.52 at the end of the study (P < .001). All the patients who were previously treated but uncontrolled, with acid inhibitors like proton pump inhibitors (PPIs), histamine 2 receptor antagonists (H2RAs) etc. had a significant reduction in the VAS score from 164.38 ± 64.54 to 35.56 ± 54.24 on day 28 (P<.001). Troxipide was well tolerated with overall incidence of adverse events being 1.05% (n=15) and all the events were resolved without any sequel. Conclusion: The present study demonstrates that Troxipide symptomatically controls APDs like gastritis, dyspepsia, gastro-esophageal reflux disease (GERD) and ulcers with good tolerability.

A Comparative Evaluation of Lafutidine and Rabeprazole in the Treatment of Gastritis and Peptic Ulcer: A Double-blind, Randomized Study in Indian Patients.

Aims: To assess the efficacy of lafutidine therapy versus rabeprazole in Indian patients with endoscopically and histologically proven gastritis and peptic ulcer. Study Design: A double blind, double dummy, randomized, comparative study. Place and Duration of Study: Global Liver and Gastroenterology Centre, Bhopal, India, between March 2010 and October 2010. Methodology: A total of 100 patients were enrolled, including 50 with endoscopically and histologically proven gastritis and other 50 with peptic ulcer (over 5 mm in diameter). Each group was randomized to receive either lafutidine or rabeprazole tablet and their corresponding competitor placebo dummy tablet, for a period of 4 weeks. Cure rate was confirmed endoscopically at the end of week 4 as compared to the baseline evaluation. Symptom response and Helicobacter pylori (H. Pylori) eradication were also compared among the two drugs at the end of the treatment period. Results: Complete cure of gastritis was observed in all the patients (100%) treated with lafutidine and 95.24% [20/21; 95% CI: 76.18 to 99.88%] patients treated with rabeprazole. Complete cure of ulcer was observed in 72.0 (18/25, 95% CI = 50.61 to 87.93%) and 79.16% (19/24, 95% CI = 57.85 to 92.87%) patients treated with lafutidine and rabeprazole respectively. There was no significant difference in gastritis/ulcer cure rate and symptom response rate between the two treatment groups at the end of the study. H pylori eradication rates was 82.61% (19/23) in lafutidine group vs 47.37% (9 /19) in rabeprazole group (Δ=35.2%, 95% CI = 3.2 to 67.3%; P= .023). Both, lafutidine and rabeprazole were well tolerated during the entire study. Conclusion: Endoscopically proven cure rate in patients suffering from gastritis and peptic ulcers is found to be comparable after 4 weeks treatment with Lafutidine and rabeprazole, but lafutidine showed better H. pylori eradication rate as compared to rabeprazole.

A Study to Evaluate the Symptomatic Efficacy and Safety of LafaxidTM (Lafutidine 10mg) in Patients with Acid Peptic Disorders in India.

Aims: To evaluate the symptomatic efficacy and safety of Lafaxid™ (lafutidine 10 mg) in Indian patients with Acid Peptic disorder (APD). Study Design: An observational, prospective, uncontrolled, open-label multi-centric study. Place and Duration of Study: Patients were recruited from 12 cities across India by 61 investigators, between October 2010 and December 2011. Methodology: We included 1500 patients (973 men, 527 women; age range 15-85 years) with Acid Peptic disorder. Lafutidine (10 mg tablets) was prescribed by the physicians as once daily dose (OD) for 28 days. The efficacy was analysed based on the change in the symptom baseline score on the 100 point Visual Analogue Scale (VAS) for individual symptoms, and the safety was determined based on adverse events reported during the study with the prescribed usage of lafutidine on day 14 and day 28 after start of the treatment. Results: Lafutidine monotherapy was given to 1378 patients. A very high reduction in the mean VAS score was observed from baseline for individual symptoms, viz. nausea, vomiting, belching, heart burn, epigastric pain, acid regurgitation, abdominal bloating & loss of appetite at the end of the study. The global mean VAS score (a sum of individual symptom VAS score) of these patients decreased from 120.34 ± 67.58 to 14.18 ± 26.97 at the end of the study (P < .001). There were 124 APD patients, previously treated but uncontrolled, with acid inhibitors like PPIs, H2RAs etc., also showed a significant reduction (157.42 ± 83.88 to 26.47 ± 46.34) in the VAS score on day 28 (P<.001). During the entire study, adverse events of mild and moderate nature were observed in 0.4% (6 patients) of the total patient population. Conclusion: The present study demonstrates that therapy with Lafaxid™ is symptomatically effective and well tolerated in patients with APDs.

Post Marketing Assessment of the Efficacy and Safety of Netromax (Netilmicin) in the Indian Pediatric Population.

Objective: A post-marketing study of Netilmicin (Netromax™) in Indian pediatric patients to assess the safety and efficacy of the drug in various susceptible infections. Method: The study was carried out by 129 pediatricians from across India in 10 states (Maharashtra, Delhi, Uttar Pradesh, Andhra Pradesh, Odisha, Chhattisgarh, Karnataka, Madhya Pradesh, West Bengal, and Bihar) from November 2011 to February 2012. A total number of 542 case report forms were collected and considered eligible for further analysis based upon the completeness of data. The disease profile of patients included bacteremia, septicemia (including neonatal sepsis), severe respiratory tract infections (RTI), intra-abdominal infections (including peritonitis), kidney and genitourinary tract infections, skin and soft tissue infections, burns, bone and joint infections, wounds and perioperative infections. Result: Demographic analysis showed the median age of patients to be 13 months and median duration of therapy was 5 days. Intravenous route (IV) (n= 340) was preferred over intramuscular route (IM) (n=202) by the physicians. Netilmicin was administered in the therapeutic dose range depending upon the age and severity of the condition. The results revealed a favorable clinical efficacy and safety profile of Netilmicin. Clinical Improvement was observed in 98% (n=532) of patients among whom, clinical resolution (Defined as the absence of the infection) was achieved in 63% (n=343) patients. Whereas, partial improvement (defined as partial disappearance of original symptoms and no further requirement of antibiotics) was observed in 35% (n=189) of patients. Adverse events were reported in 11% of the entire study population and were mild in nature. There was no serious adverse event reported during the study period. Conclusion: The present post-marketing study confirmed that at the given doses and duration of therapy, NetromaxTM exhibited remarkable antibacterial efficacy with no serious incidences of toxicity. Thereby giving evidence that NetromaxTM treatment is safe and effective among the Indian pediatric population.

Comparison between Ferrous Ascorbate and Colloidal Iron in the Treatment of Iron Deficiency Anemia in Children from Kolkata India.

Aim: To compare the efficacy and safety of ferrous ascorbate and colloidal iron in children with iron deficiency anemia. Study Design: An open, randomized, comparative, parallel-group study. Place and Duration of Study: Department of Pediatric Medicine of ‘Nilratan Sircar Medical College and Hospital’, Kolkata, India, between January 2009 and February 2010. Methodology: Children between the age group of 6 months to 12 years were included if they had anemia defined as hemoglobin <10 gm%. Children received treatment with either ferrous ascorbate or colloidal iron for 12 weeks. Each child received elemental iron 3 mg/kg body weight/day. Follow-up assessments were performed at the end of week 4, week 8 and week 12. Results: Out of the 137 children screened, 80 were included in the analysis. The mean rise in hemoglobin at the end of the 12 weeks was significantly higher in ferrous ascorbate group than colloidal iron group [3.24 ± 1.66 gm% vs. 1.42 ± 2.04 gm%; p <0.01]. Responder rate (hemoglobin ≥11.5 gm%) after 12 weeks of therapy was 53.57% in ferrous ascorbate group versus 10.34% in colloidal iron group; p<0.01. Conclusion: The study provides evidence for the role of ferrous ascorbate as an efficient oral iron supplement in the treatment of iron deficiency anemia in children.