Global Journal of Clinical Trials

Abstract: This study is part of ongoing research into natural alternatives for thetreatment of hypertension, a major public health problem.The objective is to evaluate the effects of the aqueous extract of Gynura procumbens (Lour.) Merr. leaves on L-NAME-induced HTA in Wistar rats. The methodology involved inducing hypertension in rats with L-NAME (20mg/kg, oral) for 7 days. The rats were then randomly divided into 5 groups. The first group was sacrificed, and the other 4 were treated with distilled water (1 ml/100 g), aqueous extract of G. procumbens (250 and 500 mg/kg), captopril (50mg/kg) orally once daily for 7 days. In addition, one group was used as a control. At the end of the 14th day, body weight was measured, and DBP, SBP, and HR were measured using the invasive method. The results showed that administration of L-NAME led to a significant increase of 37.19% in SBP and 63.88% in DBP compared to the control group. In contrast, treatment with G. procumbens extract at doses of 250 and 500 mg/kg, resulted in significant reductions in SBP (28.62% and 30.68%, respectively) and DBP (35% and 45.98%). Furthermore, administration of this extract also reduced heart rate, demonstrating a cardiosuppressive effect. The aqueous extract of G. procumbens appears to have an antihypertensive effect comparable to that of captopril. This study supports its traditional use and calls for further research to explore its mechanisms of action and clinical application.

Abstract: Objective: To determine the effects of exer-game balance training on dementia level, quality of life, and self- efficacy in older adults with mild cognitive impairment (MCI), comparing wobble board and stable-surface training.  Design: Randomized controlled trial.  Setting: Physiotherapy Department, Railway General Hospital, Rawalpindi, Pakistan.  Participants: Thirty-two patients with MCI (18 experimental, 14 control) were randomly allocated using sealed envelopes.  Interventions: The experimental group performed exer-game balance training on a modified wobble board, while controls trained on a Nintendo Wii Fit platform. Both groups completed 24-minute sessions, three times weekly for eight weeks.  Measures: Outcomes included dementia-related quality of life (DEMQOL), cognition (MoCA), dementia level (CDR), and self-efficacy (General Self-Efficacy Scale), assessed at baseline and eight weeks.  Results: Both groups showed significant within-group improvements (p≤0.05). Between-group differences were significant for MoCA (p=0.02) and CDR (p=0.05), but not DEMQOL (p=0.46) or self-efficacy (p=0.74).  Conclusion: Both training modalities effectively improved cognition, dementia level, quality of life, and self- efficacy in older adults with MCI.

Abstract: Aim of this work is to analyse come condition that can affect the urinary flux form the bladder neck and the uretra with inflamatory or not inflamatory pathogenetic movens.All this condition are reponsible of an inefficient urinary flux with all it is involved. The role payed by pelvic floor muscle is analyzed as well as the infective -inflamatory role played by pr ostatic chronic infection.  Are also reported literature about the reverse action played by some antibiotic and antinflamatory therapy to reverse the deposition of collagen and fibrotic process in the interconnection bladder neck and urethra.  This work can have relevance both in benign patology but also in oncological setting.

Abstract: Background Burns represent one of the most prevalent traumatic injuries worldwide, with an estimated annual global incidence of approximately 11 million cases, predominantly affecting low- and middle-income countries. Despite advances in modern wound care, including advanced dressings, skin grafting, and negative pressure wound therapy, the management of partial-thickness burns remains challenging due to prolonged healing times, excessive scar formation, and substantial healthcare costs. Mongolian medicine horse oil rubbing therapy (MMHRT), an ethnomedical practice with over 800 years of documented clinical use in Inner Mongolia, China, has demonstrated promising wound healing outcomes in preliminary clinical observations. However, rigorous evidence supporting its efficacy and mechanistic basis has been lacking. Objective This study aimed to evaluate the clinical efficacy and explore the molecular mechanisms of MMHRT in promoting burn wound healing through a randomized, controlled, parallel-group clinical trial. Methods A total of 120 patients with superficial partial-thickness (IIa degree) burns, aged 18-65 years, with total body surface area (TBSA) involvement of 1-15% and post-injury time within 48 hours, were enrolled and randomly assigned (1:1) to the MMHRT group (n=60) or the standard silver sulfadiazine (SSD) cream group (n=60). Primary outcomes included complete wound healing time and healing rate at days 7, 14, and 21 post-treatment. Secondary outcomes encompassed pain assessment using a visual analog scale (VAS), Vancouver Scar Scale (VSS) scores at 1 and 3 months post-healing, serum inflammatory cytokine levels (TNF-alpha, IL-1beta, IL-6, IL-10), and wound tissue expression of NF-kappaB/TLR4 signaling pathway proteins. Adverse events were monitored throughout the study period. Data were analyzed using intention-to-treat (ITT) principles with appropriate statistical methods. Results The MMHRT group demonstrated significantly accelerated wound healing compared to the SSD group, with median healing time of 14.0 days (IQR: 12.0-16.0) versus 18.0 days (IQR: 16.0-21.0) in the SSD group (P<0.001). The cumulative healing rates at days 7, 14, and 21 were 18.3%, 78.3%, and 98.3% in the MMHRT group, compared with 6.7%, 43.3%, and 85.0% in the SSD group, respectively (all P<0.01). VAS pain scores were significantly lower in the MMHRT group from day 3 onward (P<0.001). VSS scores at 1 month and 3 months post-healing were significantly reduced in the MMHRT group (3.2+-1.4 vs 5.8+-2.1, P<0.001; 1.8+-0.9 vs 4.2+-1.6, P<0.001). Serum levels of pro-inflammatory cytokines (TNF-alpha, IL-1beta, IL-6) decreased more rapidly, while Glob J Clin Trials, 2026 Volume 1| Issue 1| 2 anti-inflammatory IL-10 increased more substantially in the MMHRT group. Western blot analysis revealed that MMHRT significantly suppressed TLR4/NF-kappaB pathway activation and upregulated PPARgamma expression in wound tissues. No serious adverse events were reported in either group. Conclusion MMHRT significantly accelerates burn wound healing, alleviates pain, and improves scar quality compared with standard SSD therapy. The underlying mechanisms involve modulation of the TLR4/NF-kappaB inflammatory signaling pathway, promotion of PPARgamma-mediated anti-inflammatory responses, and optimization of the local wound microenvironment. These findings provide rigorous clinical evidence supporting the traditional application of MMHRT and suggest its potential as a complementary therapeutic option for partial-thickness burn management.

Abstract: Complementary and alternative medicine (CAM) has experienced substantial global growth over recent decades, driven by increasing public interest in holistic healthcare, chronic disease management, patient empowerment, preventive medicine, and dissatisfaction with limitations of conventional biomedical approaches in certain chronic conditions. Despite widespread utilisation of interventions such as acupuncture, yoga, meditation, Ayurveda, herbal medicine, Tai Chi, chiropractic treatment, osteopathy, homeopathy, mindfulness-based therapies, naturopathy, and various mind-body interventions, scientific acceptance and integration into mainstream healthcare systems remain constrained by concerns regarding the quality, reproducibility, and methodological rigour of existing evidence. Conventional randomised controlled trial (RCT) methodologies were primarily developed for pharmaceutical interventions involving single active molecules delivered in standardised doses under highly controlled conditions. Many CAM interventions, however, are inherently complex, individualised, practitioner-dependent, multimodal, and context-sensitive, creating substantial methodological challenges when applying conventional biomedical research frameworks. Consequently, robust scientific evaluation of CAM requires methodological adaptation without compromising scientific validity or introducing bias. This article reviews the principles required for designing rigorous CAM trials, including study design, randomisation, control selection, blinding, outcome measures, placebo effects, standardisation, practitioner variability, statistical considerations, implementation science, health economics, systems biology approaches, pragmatic trial designs, real-world evidence generation, and emerging opportunities using artificial intelligence and digital health technologies. Adoption of these approaches may improve the quality of evidence available for CAM interventions and facilitate rational integration of evidence-based complementary therapies into modern healthcare systems.