Journal of Pharmaceutical Research International

Efficacy and Safety of Roflumilast in Patients with Non-Alcoholic Steatohepatitis: A Randomized Controlled Study

Tarek Mohamed Mostafa — 2026-01-06

Background: Non-alcoholic fatty liver disease is the most prevalent chronic liver disease globally. There is no defined therapy for non-alcoholic steatohepatitis (NASH).

Aim: This study aimed at evaluating the efficacy and safety of Roflumilast in patients with non-alcoholic NASH.

Methods: This randomized controlled parallel study involved 55 patients with NASH who were randomized into vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily and roflumilast group (n=31) which received roflumilast 500 μg once daily for three months. Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor –alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed.

Results: Compared to the control group, after 3 months of roflumilast treatment resulted in a non-significant reduction in body weight and body mass index (P=0.126), (P=0.713) respectively, significant improvement in liver enzymes, blood glucose, HOMA-IR, triglyceride, TNF-α, MDA, TGF-ß1 levels and significant improvement in liver stiffness (all P<0.001). In addition, oral roflumilast proved safety in patients with NASH since it doesn't provoke any serious adverse reaction.

Conclusion: Roflumilast may be a promising therapy for NASH as it may decrease hepatic steatosis and fibrosis through its anti-inflammatory and anti-oxidative effect.

Wound Healing Property of Saponins of Herbal Drugs

Iram Rais — 2026-01-09

A combined study was conducted on five important medicinal plants: Centella asiatica (L.) Urban (1), Calotropis procera (Br.) (2), Mentha piperita L. (3), one of the most economically important aromatic and medicinal crop worldwide; Sida cordifolia (Linn). (4), and Euphorbia neriifolia L. (5), a species of spurge found in West Bengal and other regions of India. On the basis of their importance in traditional systems of medicine, we have chosen these plants for screening in excision and incision wound studies. The phytochemical analysis of the aerial parts yielded five types of crude saponin extracts. After performing preliminary tests to confirm the presence of saponins in the crude extracts, we conducted experiments to analyse the effects of crude saponins 1, 2, 3, 4, and 5 on biochemical and pathological changes in Wistar rats. Fractions 1, 2, and 3 were found to enhance cellular proliferation and collagen synthesis at the wound site, as indicated by increased DNA synthesis and protein content. The post-wound tissues were removed on the fourth, eighth, twelfth, and fourteenth days and subsequently analysed for specific assays. We found that all five crude extract fractions (1, 2, 4, and crude saponin) were more effective than the other fractions. Treatments with fractions 1, 2, and 4 significantly decreased the levels of lipid peroxides (LPs), while the activities of the enzymes superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPx) were significantly increased compared to the control. The results further support the authenticity and beneficial effects of fractions 1, 2, and 4, all of which are responsible for augmented wound healing and potential antioxidant activity. These triterpenoid saponin fractions enhanced the wound healing, possibly due to their effect on cellular mechanism level, thereby creating a microenvironment conducive to tissue repair and remodelling as compared to the fraction 3 and 5.

A Review of the Anticancer Effects of Vitamin C on Some Selected Cancers

Imtiyaz Alam — 2026-01-03

Vitamin C (ascorbic acid) has long been recognised for its antioxidant properties and contributions to human health, but only recently has it been seriously reconsidered as a therapeutic agent in oncology. This article aims to provide a comprehensive synthesis of recent peer-reviewed literature on the anticancer roles of vitamin C. Recent mechanistic, preclinical, and clinical studies have converged to reveal that vitamin C can exert selective pro-oxidative cytotoxicity in cancer cells, modulate epigenetic regulators, enhance immune surveillance, and interact synergistically with conventional chemotherapeutic agents and radiation therapy. High-dose intravenous vitamin C, in particular, achieves plasma levels unattainable via oral administration and generates cytotoxic hydrogen peroxide concentrations within the tumour microenvironment, selectively eliminating malignant cells while sparing normal tissues. Experimental findings illustrate that vitamin C can arrest cancer cell proliferation, induce apoptosis, and inhibit metastasis in a broad range of tumour types—including breast, colorectal, pancreatic, and lung cancers—especially in those with underlying Kirsten rat sarcoma viral oncogene homolog (KRAS) or BRAF mutations or epigenetic aberrations.

Furthermore, vitamin C serves as a cofactor for TET enzymes and histone demethylases, reactivating silenced tumour suppressor genes and thereby promoting genomic stability. It also remodels the tumour microenvironment by strengthening extracellular matrix components and fostering anti-tumour immunity through enhanced infiltration and activity of cytotoxic lymphocytes. Epidemiological data suggest a consistent inverse relationship between dietary vitamin C intake and cancer incidence, notably for gastrointestinal and breast malignancies. Early-phase clinical trials demonstrate improved patient-reported outcomes, tolerable safety profiles, and potential enhancements in overall survival when vitamin C is administered as part of multimodal therapeutic regimens.

Despite these advances, significant controversies persist. The bioavailability of oral versus intravenous vitamin C, patient selection criteria, the optimal timing and dosing protocols, and the interaction between vitamin C and cytotoxic therapies remain unresolved. Some studies report antagonistic interactions or negligible effects in randomised control settings, highlighting the heterogeneity in trial designs and patient populations. This review systematically integrates recent advances spanning molecular mechanisms, animal models, epidemiological studies, and clinical trials to provide a nuanced appraisal of vitamin C’s anticancer potential. It also outlines controversies, limitations, and the translational challenges of incorporating vitamin C into standard oncology practice, while offering recommendations for future research directions, including biomarker-driven patient stratification, combination therapies, and nanotechnology-based delivery systems. The growing evidence base warrants larger-scale clinical investigations, with the hope of establishing vitamin C as a safe, effective, and accessible adjunct in the treatment and prevention of cancer. In sum, the synthesis of current experimental, clinical, and epidemiological data underscores vitamin C’s diverse anticancer effects and its potential for integration into comprehensive, multimodal cancer therapies.

Melatonin: A Comprehensive Review of Pharmacological Uses and Recent Advances

Imtiyaz Alam — 2026-01-06

Melatonin (N-acetyl-5-methoxytryptamine) is an indoleamine primarily secreted by the pineal gland in response to the dark-light cycle. It plays a pivotal role in the regulation of circadian rhythms and sleep-wake cycles. In recent decades, extensive research has revealed melatonin’s multifaceted physiological and therapeutic effects extending far beyond sleep regulation. It exhibits potent antioxidant and anti-inflammatory properties, modulates immune responses, and supports mitochondrial function, making it a promising candidate for managing a broad spectrum of health conditions. This review provides a comprehensive examination of recent advances in understanding melatonin’s mechanisms of action and its clinical relevance. The hormone influences cellular pathways through both receptor-dependent (MT1 and MT2 receptors) and receptor-independent mechanisms, affecting neuroendocrine signalling, redox balance, and cellular homeostasis. Emerging evidence supports melatonin’s role in the prevention and adjunctive treatment of neurodegenerative diseases such as Alzheimer’s and Parkinson’s, cardiovascular disorders including hypertension and ischemia-reperfusion injury, metabolic diseases like obesity and type 2 diabetes, and various cancers where it exhibits antiproliferative, antiangiogenic, and pro-apoptotic effects. Furthermore, the review explores pharmaceutical advancements in melatonin delivery systems, its safety profile, pharmacokinetics, and regulatory considerations across different countries. Given its low toxicity, wide therapeutic index, and synergistic potential with conventional therapies, melatonin is increasingly recognized as a valuable component in integrative medical strategies. Overall, the paper emphasizes the importance of continued research into melatonin’s diverse biological roles and its optimization as a therapeutic agent in clinical practice.