Effetti Sulla Salivazione a Seguito Della Somministrazione di un Integratore Alimentare (Aqualief®) a Base di Carnosina ed Hibiscus Nei Soggetti Xerostomici: Studio Multicentrico, Randomizzato, in Doppio Cieco, Controllato Verso Placebo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Effect of Aqualief on salivation
研究概览
简要总结
Xerostomia is defined as the subjective complaint of dry mouth. Symptoms of dry mouth may range from mild oral discomfort to significant oral disease that can compromise patients' health, dietary intake and quality of life. Xerostomia is accompanied by numerous signs and symptoms mainly in the mucous membranes, lips, tongue, salivary glands and teeth.
This study was designed to verify efficacy and safety of a novel dietary supplement (Aqualief),designed with the aim of stabilizing the saliva flux and pH at a neutral level and to improve the acid buffering capacity of saliva.
详细描述
Sixty patients with xerostomia (grade 1-2 according to RTOG/EORTC) from different etiologies were recruited at the Clinica Odontoiatrica dell'Università degli studi dell'Insubria (Varese, Italy). Exclusion criteria were subjects under treatment using drugs to treat hyposalivation (e.g. pilocarpine) and xerostomia grade ≥ 3. Patients with severe hyposalivation were excluded (saliva flow rate at baseline <0.1 ml min-1) due to their inability to dissolve the tablet formulation.
Written informed consent was received from all patients before study initiation. The study was conducted in accordance with the principles laid out by the Declaration of Helsinki 1964 and its subsequent amendments and with the International Committee on Harmonization Guidelines for Good Clinical Practice and in compliance with local ethical and legal requirements. The study was approved by the ethics committee at the participating site.
The study was a prospective, randomized, double-blind, placebo-controlled trial undertaken at the Clinica Odontoiatrica dell'Università degli Studi dell'Insubria (Varese, Italy). Eligible patients who had developed xerostomia RTOG/EORTC grade 1-2 were randomized in a 1:1 ratio, with one group receiving three Aqualief tablets (after meals: breakfast, lunch, dinner) daily for 6 days. The second group received a placebo tablet given with the same regimen. The primary objective of the study was to assess the safety and efficacy of Aqualief in stabilizing the saliva pH at a neutral level compared with placebo. The secondary objective was to determine whether Aqualief induced an increase of unstimulated or stimulated saliva and in ameliorating the symptoms related to oral dryness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomization code
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both sex
- •Age ≥ a 18 years
- •Able to understand and sign the Informed Consent, and fill in the patient's diary
- •Subjects suffering from Xerosotmia Grade 1-2 (according to RTOG/EORTC scale)
- •Sjögren Sindrome
- •Lambert-Eaton Sindrome
- •Diabetes mellitus and low metabolic control
- •Alcool abuse
- •Salivary glands trauma
- •Radio and Chemotherapy for head & neck cancer
- •Methamphetamine, cannabis, heroin abuse
- •Xerostomia caused by (single and concomitant, i.e. Anti-depressive and anxyolitic drugs; Antihistaminic drugs; Decongestive drugs; Antihypertensive drugs; Muscle relaxants; Urinary incontinence drugs; Drugs for Parkinson treatment)
- •Subjects affected by paradental pathology diagnosed according to AAOP criteria, PSR 2-3
排除标准
- •Contraindication and/or Hypersensitivity to product's components, and in particular carnosine and Hibiscus
- •Subjects that are under treatment with products or drugs ( ie pilocarpin) for hypofunctionality of salivary glands
- •Subjects with total ablation of salivary glands caused by chemo or radiotherapy
- •Use of experimental drugs during 30 days before the enrolment or during the study
- •Conditions that can interfere with the study
- •Xerostomia grade 3 or higher
研究组 & 干预措施
Aqualief® tablets
400 mg mucoadhesive tablets; three times per day just
干预措施: Aqualief (Dietary Supplement)
Placebo tablets
400 mg mucoadhesive placebo tablets, three times per day just
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Effect of Aqualief on salivation
时间窗: Change from baseline to 6 days of treatment
Changes in saliva production is measured (ml)
次要结局
- Effect of Aqualief on the pH of saliva(Change from baseline to 6 days of treatment)
- Effect of Aqualief on dry mouth symptoms(Change from baseline to 6 days of treatment)
- Safety of Aqualief(Occurrence of Adverse Events over the 6 days of treatment)
研究者
Prof. Luca Levrini
Director of the Department of Surgery and Medicine, Dental Hygiene School, Research Centre Cranio Facial Disease and Medicine, University of Insubria, Varese Italy
Università degli Studi dell'Insubria