Emcure Pharmaceuticals Ltd.

Background One of the most significant postoperative challenges faced by patients is the occurrence of acute episodes of pain and inflammation, often accompanied by the development of edema, particularly in the case of large wounds. Consequently, any delay in the healing process of such wounds can exert a substantial impact on recovery. This delay can potentially be mitigated by addressing the moisture imbalance at the wound site using proteases, while concurrently minimizing pain and inflammation through the use of appropriate analgesic and anti-inflammatory preparations. The objective of this study was to evaluate the safety and efficacy of Tibrolin® D, a fixed-dose combination comprising trypsin, bromelain, rutoside, and diclofenac tablets, in alleviating pain intensity and enhancing wound healing in patients experiencing acute pain resulting from uncontaminated minor orthopedic surgical procedures or wounds. Method An open-label, multicenter, controlled, comparative Phase IV clinical study was conducted on 200 patients who underwent elective, clean, and uncontaminated minor orthopedic surgery. These patients were randomized (1:1) to receive either Tibrolin® D (a combination of trypsin 48 mg, bromelain 90 mg, rutoside 100 mg, and diclofenac 50 mg) or Voveran® 50 GE (diclofenac 50 mg) as one tablet orally, thrice a day postoperatively for seven days. The primary outcome was the proportion of patients reporting adverse events. Secondary outcomes included a total wound symptom score, evaluated based on symptoms after minor orthopedic surgery using a four-point Likert scale, and pain intensity assessed by the Numerical Pain Rating Scale. Results No adverse events were observed in this study. Both groups demonstrated statistically significant improvement (p < 0.001) in all assessed wound symptoms: erythema, edema, discharge, induration, local irritation, tenderness, and pain. By Day 7, total wound symptom scores significantly decreased in both the Tibrolin® D group (12.84 ± 2.89 to 2.24 ± 2.08) and the diclofenac group (12.86 ± 3.29 to 2.66 ± 2.28) (p < 0.001), with no significant difference between groups (p = 0.318). Pain intensity also decreased significantly in both groups by Day 7 (p < 0.001), with no significant difference in mean change between groups (p = 0.412). Notably, 91% of patients and 96% of investigators rated Tibrolin® D as good to excellent in relieving wound symptoms, comparable to ratings for diclofenac (88% and 96%, respectively). Conclusion Tibrolin® D was as well tolerated as diclofenac, indicating a favorable safety profile. The findings also suggest that Tibrolin® D improves wound healing symptoms and reduces pain intensity following minor orthopedic surgeries, demonstrating efficacy comparable to diclofenac.

Background Trelagliptin and vildagliptin are oral dipeptidyl peptidase-4 (DPP-4) inhibitors used in the treatment of type 2 diabetes mellitus. The administration of vildagliptin is twice daily, whereas trelagliptin provides the convenience of once-weekly dosing, which may enhance patient adherence. A phase 3 clinical trial was conducted to assess the non-inferiority of trelagliptin compared to vildagliptin. Methods This multicenter, randomized, open-label, parallel-group, active-controlled non-inferiority clinical trial was conducted at 10 geographically distinct sites across India. A total of 240 treatment-naive patients with type 2 diabetes mellitus were randomized in a 1:1 ratio to receive either trelagliptin (100 mg once weekly) or vildagliptin (50 mg twice daily) for 16 weeks. The primary endpoint was non-inferiority of trelagliptin to vildagliptin in reducing glycated hemoglobin (HbA1c) levels from baseline to week 16. Secondary efficacy measures included changes in fasting and postprandial blood glucose, fasting insulin, glucagon, C-peptide, and glucagon-like peptide-1 (GLP-1) levels. Safety was assessed based on the incidence of adverse events. Results At week 16, the mean HbA1c levels were 7.18 ± 1.47% and 7.21 ± 1.49% in trelagliptin and vildagliptin groups, respectively (Δ -0.89% vs. Δ -1.00%, p < 0.0001). The difference between groups was 0.11% (95% CI: -0.28 to 0.50; p = 0.5899), showing non-inferiority of trelagliptin. A total of 48.57% of patients in the trelagliptin group and 47.57% in the vildagliptin group achieved the target HbA1c level of <7% (p = 0.8850). No statistically significant differences were observed between the groups for glycemic parameters, including fasting blood glucose (Δ 1.11; 95% CI: -16.79 to 19.02; p = 0.9025), 2-hr postprandial glucose (Δ 3.33; 95% CI: -30.55 to 23.88; p = 0.8093), fasting serum insulin (Δ 5.22; 95% CI: -15.01 to 25.45; p = 0.6113), fasting glucagon (Δ 0.72; 95% CI: -96.34 to 94.90; p = 0.9882), C-peptide (Δ 0.36; 95% CI: -0.31 to 1.03; p = 0.2912), and GLP-1 levels (Δ -0.02; 95% CI: -0.06 to 0.02; p = 0.3995). All reported adverse events were mild in nature and resolved without any lasting effects. Adverse events occurred in 6.67% (8/120) of patients in the trelagliptin group and 9.17% (11/120) in the vildagliptin group. Conclusions Trelagliptin showed a significant reduction in HbA1c, fasting, and postprandial glucose levels, indicating effective glycemic control in patients with type 2 diabetes mellitus. The study drug exhibited a favorable safety profile, with no major adverse events reported. Overall, trelagliptin proved to be both efficacious and well-tolerated, demonstrating non-inferiority to vildagliptin.

Menopause affects 1.5 million women annually, with perimenopause lasting 2-8 years and causing symptoms like hot flashes, sleep disturbances, mood changes, and joint pain. While hormone replacement therapy (HRT) is effective, safety concerns limit its use, leading many women to seek nonhormonal alternatives. Nutraceuticals such as ashwagandha, vitex, and black cohosh offer potential benefits, with 80% of women using supplements. This study evaluates the efficacy and safety of Arth perimenopause multisymptom capsules, providing evidence for nutraceuticals as an alternative to HRT.

The Effectiveness of Multisymptom Support for Better Relief and Alleviation of Common Effects in Perimenopause (EMBRACE PERIMENOPAUSE) study was a prospective, observational trial conducted at Redkar Hospital and Research Center, Goa. Thirty perimenopausal women aged 40-48 years with irregular menstrual cycles and at least two menopausal symptoms received one Arth capsule daily for 60 days. Using standardized case report forms, data were collected at screening, baseline, and days 7, 15, 30, and 60. Primary outcomes included changes in menopausal symptoms (Menopause Rating Scale (MRS)), reduction in daily hot flashes, and improvement in breast tenderness. Secondary outcomes assessed the quality of life (QoL), changes in hair and skin texture, patient and physician global assessments, and intervention tolerability. Statistical analyses included Chi-square tests and analysis of variance (ANOVA) (p < 0.05).

At baseline, 100% of patients reported hot flashes, followed by irritability (90%) and night sweating (83%). The mean MRS score decreased from 39 at baseline to 2.74 by day 60 (-92.97%, p < 0.01). By day 60, 93% of patients achieved complete resolution of hot flashes, 88% for sweating, 91% for anxiety, and 90% for depressive mood (p < 0.05). Overall, treatment significantly improved menopausal symptoms, QoL, and patient satisfaction.

Arth Perimenopause Multisymptom Support capsules demonstrated significant efficacy in alleviating perimenopausal symptoms while improving QoL. This nonhormonal, well-tolerated nutraceutical represents a promising alternative for managing perimenopause-related discomfort.