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

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Completed
Phase 3

Conditions

Xerostomia
Sjogren's Syndrome

Treatments

Other: natural herbs of coconut, aloe vera, and pepperint
Other: carboxy methyl cellulose

Study type

Interventional

Funder types

Other

Identifiers

NCT04252209
OMD3-7-2 CairoU

Details and patient eligibility

About

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.

Full 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 The medication will be withdrawn if any allergic reaction occurs.

Enrollment

24 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

24 participants in 2 patient groups

patients with sjogren's received natural mixture
Experimental group
Description:
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%. applied topically in all surfaces of oral mucosa 4 times daily after eating and before sleep
Treatment:
Other: natural herbs of coconut, aloe vera, and pepperint
patients with sjogren's recievrd CMC
Active Comparator group
Description:
the control is a moisturizing gel containing 3% peppermint essential oil, 3% carboxy methyl cellulose, 10% propylene glycol, and 0.1% potassium sorbate and water up to 100%. applied topically in all surfaces of oral mucosa 4 times daily after eating and before sleep
Treatment:
Other: carboxy methyl cellulose

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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