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Background: For preventing preterm labor, the recommended duration of atosiban infusion is 48 hours and the patient has to be hospitalized during the course of treatment. The treatment consists of administering one vial of 0.9 ml as a bolus and then an infusion at a rate of 300 mcg/min for 3 hours followed by 100 mcg/min for the next 45 hours, utilizing nine vials of 5 ml. The objective of the study was to evaluate an alternative brief duration (14-hour) of atosiban treatment involving a bolus dose of 0.9 ml followed by an infusion of 300 mcg/min for 2 hours and 100 mcg/min for the next 12 hours utilizing 3 vials of 5 ml. The advantage being that the treatment could be completed in an outpatient setup and be convenient for the patient as well as for the healthcare staff. This would also reduce the overall cost of the treatment. This prospective single-center study was conducted to evaluate the efficacy and safety of an atosiban brief duration (14-hour) treatment regimen to prevent preterm labor. Methods: A total of 50 patients with symptoms of preterm labor were enrolled in the study. The efficacy of tocolysis was determined by the percentage of patients who remained undelivered up to 48 hours after atosiban therapy initiation and the follow-up of the patients was done up to delivery. Safety was assessed in terms of the number of maternal and fetal adverse events reported. Results: The mean gestational age at the enrolment was 32.1±2.6 weeks and the delivery were delayed by a mean of 18.13±17.97 days (range 1-62 days). Thirty-five (70%) patients remained undelivered at 48 hours and 29 (58%) at 7 days. No maternal or fetal adverse events were reported during the study. Conclusions: A favourable safety and efficacy profile of a brief duration atosiban regimen was observed resulting in ease of administration and a shorter stay in the healthcare facility providing convenience to both patient and hospital staff. The overall cost of the therapy was also reduced. Further clinical trials with larger sample size are required to confirm the findings.

Aim: The aim of this study was to evaluate the anti-hypertensive efficacy of a fixed-dose combination (FDC) of Efonidipine 40 mg and Telmisartan 40 mg in Stage II hypertensive patients. Study Design: Multicentric, randomized, double-blind, parallel, comparative Phase III clinical trial. Methodology: This clinical trial was conducted at six geographically distributed sites across India and enrolled 240 Stage II hypertensive patients. They were randomized into two groups in a ratio of 1:1 using computer-generated block randomization to receive E+T (FDC of Efonidipine 40 mg + Telmisartan 40mg) or C+T (FDC of Cilnidipine 10 mg + Telmisartan 40 mg) group intervention once daily for a period of 90 days. The study site staff, investigator and patients were blinded to the treatment allocation. The primary endpoint of the study evaluated the mean reduction in sitting systolic BP (SBP) and diastolic BP (DBP) from baseline to day 90 whereas the secondary endpoints assessed were mean reduction in BP from baseline to day 30 & 60, patients achieving target BP (

Aim: To evaluate the antihypertensive efficacy and safety of the fixed-dose combination (FDC) of Efonidipine and S (-) Metoprolol in adult patients with hypertension. Study Design: Multicentric, double-blind, randomized, parallel, comparative Phase III trial. Methodology: This clinical trial was conducted at five geographically distributed sites across India and enrolled 240 hypertensive patients. They were randomized (1:1) to receive either FDC of Efonidipine 40 mg + S (-) Metoprolol 25 mg tablet (E+S(-)M group) or FDC of Cilnidipine 10 mg + Metoprolol 50 mg tablet (C+M group) once daily for 90 days. Patients were evaluated for changes in their blood pressure (BP) from baseline to Day 30, 60 and 90. The study site staff, investigator and patients were blinded to the treatment allocation. Blood pressure was recorded as the mean of 3 consecutive measurements taken in a sitting position. Patients achieving target BP (

Aim: This study is aimed at evaluating the efficacy and safety of Intravenous Glutathione in moderate COVID-19 patients with respiratory distress. Study Design: A randomized, multicentric, double-blind, placebo-controlled, comparative Phase III clinical trial. Place and Duration of Study: This clinical trial was conducted at 7 geographically distributed sites across India between February 2021 to September 2021. Participants: The study enrolled 240 participants who were tested and confirmed cases of moderate COVID-19 with respiratory distress. Interventions: Intravenous glutathione (GSH) at a loading dose of 2400 mg on the first day, followed by a dose of 1200 mg every 12 hours for seven days. Methodology: Patients were randomized into two groups in a ratio of 1:1, to receive either glutathione or placebo. Both the study drugs were given as an addition to the standard of care (SOC). The study site staff, investigator and patients were blinded to the treatment allocation. The primary endpoint of the study was two or more points of improvement on the WHO 7-point ordinal scale whereas the secondary endpoints were the proportion of patients not requiring oxygen supplementation after treatment. Other secondary endpoints included the proportion of patients who changed from a higher to a lower score on the WHO 7-Point ordinal scale, the proportion of patients remaining hospitalized, the need of non-invasive ventilation or new requirement of high flow oxygen use, and incidences of adverse events. Results: A significant clinical improvement in the GSH group (p

Aims: To assess the efficacy and fetomaternal safety of atosiban among Indian pregnant women presenting with preterm labor. Study Design: Prospective, open-label, multicentric, non-comparative, phase-IV clinical study. Place and Duration of Study: Department of Obstetrics and Gynaecology at nine hospitals across India from October 2016 to December 2019. Methodology: A total of 212 pregnant women admitted with preterm labour between 24 and 36 weeks of gestation were administered intravenous atosiban up to 48 hours. Efficacy was defined as the successful delay of delivery without the need of an additional or alternative tocolytic agent for 72 hours. Safety was evaluated by recording the occurrence of adverse events in the mother, fetus and neonate. Results: Tocolytic efficacy of Atosiban was 84.88% at 48 hours and 74.15% at day 7 without additional tocolytic agent or retreatment after 48 hours. The mean number of days gained after the start of atosiban tocolysis were 29.15 ± 1.82 days with mean gestational age at delivery of 35.1 ± 3.33 weeks. Atosiban reduced the frequency of contractions from 4.3 ± 1.47 to 0.67 ± 1.13 contractions/30 min at 72 hours. The proportion of neonates with birth weights more than 2,500 gm was 41.67%. A total of 205 neonates out of 216 (94.95%) had APGAR score more than 7 after 5 minute. Atosiban successfully delayed the labour in 92.31% (n=13) of “Twin pregnancy” patients for 48 hours and beyond 7 days in 9 patients (69.2%). There were no serious adverse events reported. Conclusions: In patients with threatened preterm birth, 48 hour tocolysis with atosiban was found to be safe and effective in preventing imminent preterm birth even when it was a twin pregnancy or associated with co-morbidities. Atosiban showed favorable side effects profile and improved the perinatal outcomes. Clinical Trial Registry of India Number: CTRI/2017/03/008065

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, Bangalore between 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 7 and 7.56 ± 2.40 vs 6.22 ± 2.55; P < .0001 on day 15 in the patients 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®.

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

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.

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

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

To compare the efficacy of ferrous ascorbate and colloidal iron in the treatment of iron deficiency anemia in children.Eighty one children, aged 6 mo to 12 y, were screened for iron deficiency anemia (IDA) and those diagnosed with IDA were randomized to receive ferrous ascorbate or colloidal iron for a period of 12 wk, such that each child received elemental iron 3 mg/kg body weight/d. Increase in hemoglobin (Hb) level was the primary outcome measure. Assessment was performed at baseline, wk 4, wk 8 and wk 12.Of 81 children screened, 73 were included in the study. The mean rise in Hb at the end of the 12 wk was significantly higher in ferrous ascorbate group than the colloidal iron group [3.59 ± 1.67 g/dl vs. 2.43 ± 1.73 g/dl; P 0.01]. Significantly higher proportion of children receiving ferrous ascorbate (64.86 % vs. 31.03 %; P 0.01) became non-anemic in comparison to colloidal iron.Ferrous ascorbate provides a significantly higher rise in hemoglobin levels in comparison to colloidal iron. The study supports the use of ferrous ascorbate in the pediatric age group, providing evidence for its role as an efficient oral iron supplement in the treatment of iron deficiency anemia.

The present study was undertaken to assess the impact of intravenous iron sucrose (Feronia IV) in the treatment of iron deficiency anemia observed in gynecological and obstetrical practice.Seventy-seven practicing gynecologists and obstetricians throughout India collaborated in the recruitment of 145 women over a period of 1 year, of which 143 were analyzable cases.The overall mean rise in hemoglobin level was observed to be 2.43 gm % at the end of 4 weeks. The dose of iron sucrose administered ranged from 100 to 1,050 mg. In women who received 200 mg of the drug, and the mean Hb rise was found to be 2.21 ± 1.06 gm %. The highest observable rise in hemoglobin level was 5.5 gm % with 800 mg of iron sucrose. No serious adverse reactions were reported during the observation period.Intravenous Iron sucrose is a safe and effective treatment for the rapid reversal of iron deficiency anemia, in obstetric and gynecological settings.