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临床试验/NCT01564849
NCT01564849Unknown不适用

The Clinical Efficacy of Topical Nasal Pomegranate Fruit Extract (PFE) for Patients With Chronic Rhinitis, Chronic Sinusitis With or Without Nasal Polyps

Hillel Yaffe Medical Center1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
198
试验地点
1

研究概览

简要总结

An explosion of interest in the numerous therapeutic properties of Punica granatum over the last decade has led to numerous in vitro, animal, and clinical trials. Pomegranate is a potent antioxidant, superior to red wine and equal to or better than green tea. In addition, anticarcinogenic and anti-inflammatory properties suggest its possible use as a therapy or adjunct for prevention and treatment of several types of cancer and cardiovascular disease. Because of pomegranate's antimicrobial properties, it may aid in preventing infection by dental pathogens, pathogenic E. coli O157:H7, and antibiotic-resistant organisms such as methicillin-resistant Staphylococcus aureus (MRSA) Pomegranate's effect on bacterial pathogens has only been tested in vitro, however, necessitating human trials to refute or substantiate any clinical effect.

The possibility that pomegranate extracts may also have an effect on several other disease processes, such as Alzheimer's and obesity, underscores the need for more clinical research. Currently, numerous clinical trials are in progress exploring the therapeutic potential of pomegranate extracts.

Aim The investigators want to evaluate the effect of Punica granatum components on Chronic sinusitis, nasal polyps and chronic rhinitis.

详细描述

There are many publications indexed by Medline dealing with pomegranate and Punica granatum and there is interest in pomegranate as a medicinal and nutritional product.

The pomegranate tree, Punica granatum, especially its fruit, possesses a vast ethnomedical history and represents a phytochemical reservoir of heuristic medicinal value. The tree/fruit can be divided into several anatomical compartments: (1) seed,(2) juice, (3) peel, (4) leaf, (5) flower, (6) bark, and (7) roots, each of which has interesting pharmacologic activity. Juice and peels, for example,possess potent antioxidant properties, while juice, peel and oil are all weakly estrogenic and heuristically of interest for the treatment of menopausal symptoms and sequelae. The use of juice, peel and oil have also been shown to possess anticancer activities, including interference with tumor cell proliferation, cell cycle, invasion and angiogenesis. These may be associated with plant based anti-inflammatory effects. The phytochemistry and pharmacological actions of all Punica granatum components suggest a wide range of clinical applications for the treatment and prevention of chronic inflammation.

Pomegranate as few medical applications as gastrointestinal infections, oral wounds and others. There is a publication on the positive use of pomegranate, in reducing of trigeminal pain post Herpes Zoster infection (1). Another work described the synergistic effect of pomegranate extraction and antibiotics for Staphyloccocus Areus (2). Pomegranate extraction was used for viral delay of HIV I in AIDS patients (3).

It's antiviral effect was examined against HSV and RSV (6). There was a positive effect on H7 -E. COLI 0157(4). Pomegranate extraction was found to help as antibacterial effect as other Mexican extraction drugs, for Gastrointestinal infections (5). High concentrations of phenol substances was evaluated in wound healing and it was efficient (7). Methanolic substances from pomegranate extraction was evaluated and found efficient for all the bacteria that was examined (8). Recently pomegranate extraction was found active in antibacterial effect and in synergism with tetracyclin against staphyloccocus Areus with Methicillin resistance (MRSA).

Pomegranate polyphenol extract (PPE) has anti-influenza properties. Using real time PCR, plaque assay, and TCID 50% hemagglutination assay, the investigators have shown that PPE suppresses replication of influenza A virus in MDCK cells. PPE inhibits agglutination of chicken red blood cells (cRBC) by influenza virus and is virucidal. The single-cycle growth conditions indicated that independent of the virucidal effect PPE also inhibits viral RNA replication. PPE did not alter virus ribonucleoprotein (RNP) entry into nucleus or translocation of virus RNP from nucleus to cytoplasm in MDCK cells. The investigators evaluated four major Polyphenols in PPE (ellagic acid, caffeic acid, luteolin, and punicalagin) and demonstrated that punicalagin is the effective, anti-influenza component of PPE. Punicalagin blocked replication of the virus RNA, inhibited agglutination of chicken RBC's by the virus and had virucidal effects. Furthermore, the combination of PPE and oseltamivir synergistically increased the anti-influenza effect of oseltamivir. In conclusion, PPE inhibited the replication of human influenza A/Hong Kong (H3N2) in vitro. Pomegranate extracts should be further studied for therapeutic and prophylactic potential especially for influenza epidemics and pandemics.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • above age 18
  • under age 80
  • patients with chronic rhinitis, sinusitis and nasal polyps
  • patients candidates for surgery or medical therapy

排除标准

  • Patients that had nasal surgery before
  • Diabetes, chemotherapy or radiation therapy
  • Allergy to yeasts or pomegranate

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Itzhak Braverman

Head Otolarungology Head and Neck Surgery Unit

Hillel Yaffe Medical Center

研究点 (1)

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