the Effect of Mixture of Natural Products As Salivary Substitutes in Treatment Of Xerostomia
Condition: Sjogren's Syndrome; Xerostomia
MeSH terms: Sjogren's Syndrome; Xerostomia; Syndrome
Study type: Interventional
Phase: Phase 3

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 The medication will be withdrawn if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.
    

Intervention name(s): natural herbs of coconut, aloe vera, and pepperint; carboxy methyl cellulose
Intervention type(s): Other; Other
Intervention description(s): mixture of herbal oils of coconut, peppermint, aloe vera; a moisturizing gel contained 3%carboxy methyl cellulose, 3% peppermint essential oil, 10% propylene glycol, 0.1% potassium sorbate, and water up to 100%.
Other intervention name(s): natural products; CMC
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 50% of patients will start with intervention (A) for 2 weeks then wash out periods for 7 days then control for 2 weeks and the other 50% will start with control for 2 weeks then wash out periods for 7 days then intervention (B) for 2 weeks.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: xerostomia; oral dryness; dry mouth