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

NCT ID: NCT04252209

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2023-03-15

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 The medication will be withdrawn if any allergic reaction occurs.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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

patients with sjogren's received natural mixture

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

Group Type: EXPERIMENTAL

natural herbs of coconut, aloe vera, and pepperint

Intervention Type: OTHER

mixture of herbal oils of coconut, peppermint, aloe vera

patients with sjogren's recievrd CMC

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

Group Type: ACTIVE_COMPARATOR

carboxy methyl cellulose

Intervention Type: OTHER

a moisturizing gel contained 3%carboxy methyl cellulose, 3% peppermint essential oil, 10% propylene glycol, 0.1% potassium sorbate, and water up to 100%.

Interventions

natural herbs of coconut, aloe vera, and pepperint

mixture of herbal oils of coconut, peppermint, aloe vera

Intervention Type: 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%.

Intervention Type: OTHER

Other Intervention Names

natural products; CMC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mahmoud abd El kader

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry, Cairo Univeristy

Cairo, , Egypt

Countries

Egypt

References

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-Controlled Trial. J Res Pharm Pract. 2018 Apr-Jun;7(2):104-110. doi: 10.4103/jrpp.JRPP_18_21.

Reference Type: RESULT

PMID: 30050964 (View on PubMed)

Other Identifiers

OMD3-7-2 CairoU

Identifier Type: -

Identifier Source: org_study_id