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

Sjogren's Syndrome Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04252209
• Other study ID #: OMD3-7-2 CairoU
• Status: Completed
• Phase: Phase 3
• Start date: March 22, 2021
• Est. completion date: March 15, 2023

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 15, 2023
• Est. primary completion date: November 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Sjogren's Syndrome
• Syndrome
• Xerostomia

Intervention

Other:
• natural herbs of coconut, aloe vera, and pepperint
mixture of herbal oils of coconut, peppermint, aloe vera
• 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%.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo Univeristy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Atashi V, Yazdannik A, Mahjobipoor H, Ghafari S, Bekhradi R, Yousefi H. The Effects of Aloe vera-Peppermint (Veramin) Moisturizing Gel on Mouth Dryness and Oral Health among Patients Hospitalized in Intensive Care Units: A Triple-Blind Randomized Placebo- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective oral dryness	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	14 days
Secondary	objective oral dryness	using the Challacombe Scale. It will be assessed by the investigator in the first visit (baseline assessments before the interventions) and in the end of two weeks (final assessments).as score 1 mean mild oral dryness and score 10 mean severe oral dryness	14 days