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

NCT04252209 | Completed Phase 3 DMC

• 1 other identifier: OMD3-7-2 CairoU
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Sjogren's Syndrome; Xerostomia

Keywords

xerostomia; oral dryness; dry mouth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• objective oral dryness

  14 days

Study Arms (2)

patients with sjogren's received natural mixture

EXPERIMENTAL

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

patients with sjogren's recievrd CMC

ACTIVE COMPARATOR

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

Interventions

natural herbs of coconut, aloe vera, and pepperint OTHER

mixture of herbal oils of coconut, peppermint, aloe vera

Also known as: natural products

patients with sjogren's received natural mixture

carboxy methyl cellulose 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%.

Also known as: CMC

patients with sjogren's recievrd CMC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo Univeristy

Cairo, 020, Egypt

Location

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

  PMID: 30050964 RESULT

MeSH Terms

Conditions

Sjogren's Syndrome; Xerostomia

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2020
• First Posted: February 5, 2020
• Study Start: March 22, 2021
• Primary Completion: November 23, 2022
• Study Completion: March 15, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2 years

Locations

EG (1)