Comparative evaluation of anti- microbial efficacy of calcium hydroxide, triple antibiotic paste, bromelain extract and Triticum aestivum extract (Wheat grass) as an intracanal medicament against Enterococcus faecalis in single rooted teeth: an in vivo study - NIL

开始日期2023-09-28

申办/合作机构-

NCT05885828 / RecruitingN/AIIT

The PRECISION-T2D Study: Precision Nutrition Study for Type 2 Diabetes

Food plays a crucial role in determining blood glucose levels, especially in people with type 2 diabetes. Precision nutrition, which involves individually tailored dietary interventions, can be a powerful tool in managing blood glucose levels in people with type 2 diabetes. Previous studies found that changes in gut microbiota resulted from the dietary intervention, such as plant-based diet, might subsequently lead to different glycemic responses, and then different health outcomes.
In this study, the investigators will characterize the blood glucose dynamics and gut microbiota of individuals with type 2 diabetes. They aim to assess the influence of plant-based diet on gut microbiota; they will also investigate the influence of gut microbiota on glycemic responses. Additionally, a series of individual N-of-1 trails will be integrated to compare the effects of a white bread breakfast and a whole wheat bread breakfast on glucose metabolism at the individual level.

开始日期2023-07-17

申办/合作机构

西湖大学

NCT05661474 / Completed临床4期IIT

The Effects of Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Patients With Diabetic Foot Ulcers: a Monocentric, Two-arm, Open-label, Randomized, Controlled Trial.

Diabetes Mellitus (DM) is one of the most widespread metabolic diseases and the alarming rise in its prevalence worldwide poses enormous challenges. The microvascular and macrovascular complications of DM heavy impact on longevity and quality of life, and in particular diabetic foot ulcers (DFUs) are among the ten top causes of worldwide disease burden and disability Essential components of the standard care, management, and treatment of DFUs are represented by health education, strict control of blood glucose and cardiovascular risk factors, offloading, local debridement, and adequate dressing. A wide variety of dressing is available, and these include basic contact dressings (low adherence dressings such as saline gauze, paraffin gauze or simple absorbent dressings) and advanced dressings (alginate, hydrogel, films, hydrocolloid, foam).
It is important underline that due to lack of evidence from head-to-head randomized controlled trials (RCTs), the relative effects of any of these dressings in DFUs remain unclear. Consequently, so far clinical evidence supporting the choice for either hydrogel or saline gauze dressing, has been related mostly on clinician perception rather than high quality evidence. Here we evaluated the efficacy and safety of Fitostimoline® hydrogel dressing versus saline gauze dressing in patients with DFUs in a monocentric, two-arm, open-label, randomized, controlled trial.

开始日期2021-02-01

申办/合作机构

Università degli Studi di Napoli Federico II

100 项与普通小麦提取物相关的临床结果

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100 项与普通小麦提取物相关的专利（医药）

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项与普通小麦提取物相关的文献（医药）

2023-05-22·Journal of clinical medicine

Triticum vulgare Extract and Polyhexanide (Fitostimoline^® Hydrogel/Fitostimoline^® Plus Gauze) versus Saline Gauze Dressing in Patients with Diabetic Foot Ulcers: Results of a Randomized Controlled Trial.

Article

作者: Giuseppe Della Pepa ; Gianluca Lombardi ; Salvatore Gianfrancesco ; Roberto Piccolo ; Giovanni Chirico ; Micaela Pellegrino ; Luigi Santella ; Nicola Tecce ; Anastasia Volpicelli ; Elena Sollo ; Lutgarda Bozzetto ; Maria Masulli ; Gabriele Riccardi ; Angela Albarosa Rivellese ; Gennaro Saldalamacchia

BACKGROUND:

The use of dressings is an essential component of the standard of care for diabetic foot ulcers (DFUs); however, despite the wide variety of dressings available, there is a lack of evidence from head-to-head randomized controlled trials. We evaluated the efficacy and safety of Triticum vulgare extract and polyhexanide (Fitostimoline^® hydrogel/Fitostimoline^® Plus gauze) versus saline gauze dressings in patients with DFUs.

METHODS:

This study involved a monocentric, two-arm, open-label, controlled trial in patients with DFUs (Grades I or II, Stage A or C, based on the Texas classification) randomized to 12 weeks of dressing with Fitostimoline^® hydrogel/Fitostimoline^® Plus gauze or saline gauze. The number of patients with complete healing, the reduction in DFU size, and the presence of local signs and symptoms of the wound and perilesional skin were evaluated every two weeks and at the end of treatment.

RESULTS:

A total of 40 adult patients were recruited (20 patients in each treatment group). The proportion of patients with complete healing was similar between the two groups (61% vs. 74%, p = 0.495, Fitostimoline^® hydrogel/Fitostimoline^® Plus gauze vs. saline gauze, respectively), without significant differences, as well as the reduction in DFU size. A significant improvement in local signs and symptoms of the wound and signs of perilesional skin in the Fitostimoline^® hydrogel/Fitostimoline^® Plus gauze compared with the saline gauze group was observed.

CONCLUSIONS:

In a clinical setting, the use of Fitostimoline^® hydrogel/Fitostimoline^® Plus gauze dressing in patients with DFUs significantly improves signs and symptoms of the wound and signs of perilesional skin compared with saline gauze dressing with a similar efficacy in terms of wound healing.

2023-04-12·Cutaneous and ocular toxicology

The effects of cream based Triticum vulgare with and without therapeutic ultrasound on excisional wound healing in diabetic rats.

Article

作者: Ayşe Gölgeli Bedir ; Latif Emrah Yanmaz

The purpose of the current study was to evaluate the effect of Triticum vulgare (TVE) alone, or combined with therapeutic ultrasound (TUS) on wound healing in a diabetic rat model. A total of 72 male Wistar rats were randomly divided into four groups: Group Control, wounded rats without treatment; Group TUS, wounded rats with TUS application; Group TVE, wounded rats treated with TVE; and Group TVE + TUS, wounded rats treated with TVE + TUS. Wound healing was assessed using wound area calculation and thermographic, biochemical, histopathologic, immunohistochemical, and immunofluorescence analyses on post-wounding days 7, 14, and 21. On day 21, the wound surface area was significantly decreased in Group TVE + TUS (0.18 ± 0.07 cm²) compared to the other groups (p < 0.001). A significant increase in wound area temperature was recorded on days 7, 14, and 21 in all groups compared to day 0 (p < 0.001). On day 21, Group TVE + TUS (35.4 ± 0.2 °C) had the most significantly highest wound area temperature compared to the other groups (p < 0.001). The highest histopathological scores were recorded in Group TVE + TUS on days 7, 14, and 21 (p = 0.04). The highest vascular endothelial growth factor expression was observed in Group TVE + TUS (82.53 ± 1.98) on day 7 (p = 0.03). In conclusion, treatment with a combination of TVE and TUS effectively enhanced wound healing in diabetic rats compared with other treatment groups.

2022-04-29·Journal of clinical medicine3区 · 医学

Clinical Evaluation of the Efficacy and Tolerability of Rigenase^® and Polyhexanide (Fitostimoline^® Plus) vs. Hyaluronic Acid and Silver Sulfadiazine (Connettivina^® Bio Plus) for the Treatment of Acute Skin Wounds: A Randomized Trial.

3区 · 医学

ArticleOA

作者: Raffaele Russo ; Albino Carrizzo ; Alfonso Barbato ; Barbara Rosa Rasile ; Paola Pentangelo ; Alessandra Ceccaroni ; Caterina Marra ; Carmine Alfano ; Luigi Losco

OBJECTIVES:

Compare the efficacy and tolerability of Connettivina^® Bio Plus (Group A) gauze and cream, and Fitostimoline^® Plus (Group B) gauze and cream for the treatment of acute superficial skin lesions.

DESIGN:

Single-center, parallel, randomized trial. A block randomization method was used.

SETTING:

University of Salerno-AOU San Giovanni di Dio e Ruggi d'Aragona.

PARTICIPANTS:

Sixty patients were enrolled. All patients fulfilled the study requirements.

INTERVENTION:

One application of the study drugs every 24 h, and a six-week observation period.

MAIN OUTCOME MEASURES:

Efficacy and tolerability of the study drugs.

RESULTS:

In total, 60 patients (Group A, n = 30; Group B, n = 30) were randomized; mean age was 58.5 ± 15.8 years. All patients were included in the outcome analysis. Total wound healing was achieved in 17 patients undergoing treatment with Connettivina^® Bio Plus and 28 patients undergoing treatment with Fitostimoline^® Plus. The greater effectiveness of the latter was significant (p = 0.00104). In Group B, a significantly greater degree of effectiveness was observed in reducing the fibrin in the wound bed (p = 0.04746). Complications or unexpected events were not observed.

CONCLUSIONS:

Both Connettivina^® Bio Plus and Fitostimoline^® Plus are secure and effective for treating acute superficial skin lesions. Fitostimoline^® Plus was more effective than Connettivina^® Bio Plus in wound healing of acute superficial skin lesions, especially if fibrin had been observed in the wound bed.

100 项与普通小麦提取物相关的药物交易

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适应症	最高研发状态	国家/地区	公司
溃疡	批准上市	意大利更多	Farmaceutici Damor SpA 更多
烧伤	批准上市	意大利更多	Farmaceutici Damor SpA 更多

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ONCOLGroup (ASCO2009) AI 标引	N/A	口腔炎	-	Triticum vulgare mouthwashes (TVM)	(鏇鬱衊衊範獵鹹夢範鑰) = 觸鑰繭艱鹹鹽鹽餘範簾夢積醖獵壓糧網選壓餘 (選糧顧範壓淵選構築鏇 )	-	2009-05-20
				Triticum vulgare mouthwashes (TVM)	(鏇鬱衊衊範獵鹹夢範鑰) = 鹽築製齋衊醖艱夢膚獵夢積醖獵壓糧網選壓餘 (選糧顧範壓淵選構築鏇 )