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

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04252209
• Collaborator: (none)
• Enrollment: 44
• Arms: 2
• Anticipated Duration (Months): 16

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sjogren's Syndrome; Xerostomia	Other: natural herbs of coconut, aloe vera, and pepperint; Other: carboxy methyl cellulose	Phase 3

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 The medication will be withdrawn if any allergic reaction occurs.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• 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.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)
• Masking Description: Trial participants will be blinded as the two interventions will have the same properties in the same container. The investigator will be blinded as he will not know the treatment assigned for the participants. Also the outcome assessor and the statistician will be blinded.
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Aug 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: natural herbs of coconut, aloe vera, and pepperint; mixture of herbal oils of coconut, peppermint, aloe vera; Other Names: natural products
Active Comparator: 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	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%.; Other Names: CMC

Outcome Measures

Primary Outcome Measures

1. subjective oral dryness [14 days]

   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

Secondary Outcome Measures

1. objective oral dryness [14 days]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alaa Mahmoud abd El kader, Principle investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT04252209
• Other Study ID Numbers: OMD3-7-2 CairoU
• First Posted: Feb 5, 2020
• Last Update Posted: Aug 19, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alaa Mahmoud abd El kader, Principle investigator, Cairo University: xerostomia; oral dryness; dry mouth
• Additional relevant MeSH terms: Sjogren's Syndrome; Xerostomia; Syndrome

Study Results

No Results Posted as of Aug 19, 2021