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临床试验/NCT04252209
NCT04252209已完成3 期

the Effect of Mixture of Natural Products As Salivary Substitute In Comparison To Carboxy Methyl Cellulose In Treatment Of Xerostomia In Patients With Sjogren's Syndrome: Cross Over Randomized Clinical Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年3月22日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
24
试验地点
2
主要终点
subjective oral dryness

研究概览

简要总结

evaluate the efficacy of natural herbal mixture of aloe vera gel, coconut oil and peppermint in comparison to the carboxy methyl cellulose on xerostomia in a sample of patients with Sjogren's syndrome.

详细描述

The study will be held in the Rheumatology clinic at El Kasr Al-Ainy Cairo University Hospital in patients with Sjogren's syndrome. Population: A random sample of adult patients diagnosed with primary or secondary Sjogren's syndrome attending at the Rheumatology clinic in El Kasr Al-Ainy, Cairo University Hospital will be enrolled in the study in a consecutive order.

The interventions will be in the form of gel to be maintained for long period in the oral cavity. The intervention is a moisturizing gel containing 10% aloe vera jelly, 10% coconut oil, 3% peppermint essential oil, 3% carboxy methyl cellulose, 10% propylene glycol, and 0.1% potassium sorbate and water up to 100%. The control is also a moisturizing gel contained 3%carboxy methyl cellulose, 3% peppermint essential oil, 10% propylene glycol, 0.1% potassium sorbate, and water up to 100%.

Both gels had similar appearance, color, smell, and weight. They will be produced by professional pharmacist in faculty of pharmacy, Al Azher university, Cairo, Egypt.it was taken from previous study with modification in percentage of aloe vera and adding coconut oil. Both gels will be applied topically in all surfaces of oral mucosa 4 times daily after eating and before sleep . The same individuals will deliver the trial interventions in all study groups, both gels will be used for 2 weeks then washout period for 7 days then cross over them. Modification of life style will be promoted as daily tooth brushing, hydration with sufficient amounts of water, eating fibrous food as fruits and vegetables, avoid any alcohol mouth wash or any other topical oral products. The medication will be withdrawn if any allergic reaction occurs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Trial participants will be blinded as the two interventions will have the same properties in the same container. The investigator will be blinded as he will not know the treatment assigned for the participants. Also the outcome assessor and the statistician will be blinded.

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

  • Adult patients
  • Patients physically able to participate in the clinical trial.
  • Patients diagnosed with Sjogren's syndrome using 2016 ACR/EULAR classification criteria (Shiboski et al., 2017).
  • Secondary sjogren patients with rheumatoid arthritis.
  • Patients with clinical oral dryness positive scores.

排除标准

  • Patients with previous radiotherapy.
  • Patients not approved to participate in the clinical trial.
  • Patients didn't complain from xerostomia.
  • Patients with diabetes mellitus.
  • Patients taking drugs caused xerostomia as antidepressants, anticholinergics, antihistamines, and anxiolytics and antihypertensives (Campos et al., 2019).
  • Patients with symptomatic oral lesions

结局指标

主要结局

subjective oral dryness

时间窗: 14 days

subjective oral dryness measured by bother 1 scale. It is patient centered scale as the patient reported how much he suffer from oral dryness on scale from 1 - 10.as 1 mean mild dryness and 10 mean severe oral dryness

次要结局

  • objective oral dryness(14 days)

研究者

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

Alaa Mahmoud abd El kader

Principle investigator

Cairo University

研究点 (2)

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