NCT04252209

the Effect of Mixture of Natural Products As Salivary Substitutes in Treatment Of Xerostomia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 The medication will be withdrawn if any allergic reaction occurs.

Conditions

• Sjogren's Syndrome
• Xerostomia

Interventions

Type	Name	Description
OTHER	natural herbs of coconut, aloe vera, and pepperint	mixture of herbal oils of coconut, peppermint, aloe vera
OTHER	carboxy methyl cellulose	a moisturizing gel contained 3%carboxy methyl cellulose, 3% peppermint essential oil, 10% propylene glycol, 0.1% potassium sorbate, and water up to 100%.

Timeline

• Start date: 2021-03-22
• Primary completion: 2022-11-23
• Completion: 2023-03-15
• First posted: 2020-02-05
• Last updated: 2023-08-09

Locations

1 site across 1 country: Egypt