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Comparison of the effectiveness of chewing gum with and without Ginger officale on dry mouth condition in patients under hemodialysis

Double blinded parallel randomized clinical trial to determine the effect of chewing gum containing Zingiber officale on dry mouth condition in patients under hemodialysis in comparison with chewing gum without Zingibr officale

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201201049550N1
Enrollment
28
Registered
2021-01-03
Start date
2020-12-30
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Xerostomia. Disturbances of salivary secretion

Interventions

Intervention 1: Intervention group: In this study, 60 gums containing ginger formulated by a pharmacist, weighing 1.5 g containing 0.15 g of ginger, are given to the intervention group. The duration o

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: People of both sexes over 18 years old Confirmation of dry mouth, regardless of the cause, by the standard dry mouth questionnaire, which includes questions related to the amount of saliva in the mouth, swallowing difficulty, a feeling of dryness while eating, the need to drink water while eating, will be examined.

Exclusion criteria

Exclusion criteria: Patients who are unable to chew gum due to oral conditions History of allergic reaction to chewing gum and its contents , including ginger Severe cognitive deterioration Effective conditions on salivary flow rate : salivary gland aplasia , severe dehydration , chemotherapy , radiation to the head and neck and medications includes : ( Tricyclics Anti Deppressants - Tranquiliser - Sedative - Anticoagulants - Antihistamines - Antihypertensive drugs - Antispasmodic and diuretics ) - Sjogren's syndrome - Diabetes Mellitus - Sarcoidosis - Human immuno deficiency virus - Hepatitis C - Graft versus Host Disease (GvHD) - Mental Disorders - Primary biliary Cirrhosis - Systemic lupus erythematosus - Rheumatoid arthritis

Design outcomes

Primary

MeasureTime frame
Stimulated saliva level. Timepoint: Measurement of stimulated saliva and non-stimulating saliva before the intervention and 14 days after chewing gum. Method of measurement: Measurement of stimulated saliva in milliliters in a plastic vial.

Secondary

MeasureTime frame
Unstimulated saliva. Timepoint: Measurement of non-stimulating saliva before the intervention and 14 days after begining the intervention. Method of measurement: Measurement of non-stimulating saliva in milliliters in a plastic vial.;Oral health related quality of life. Timepoint: Before the intervention and 14 days after the intervention. Method of measurement: Oral Health Impact Profile-14 ( OHIP-Per14 ) questionnaire.;Severity of dry mouth. Timepoint: Before the intervention and 14 days after the intervention. Method of measurement: Xerostomia Inventory (XI) questionnaire (11 questions).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Dadashi

Tehran University of Medical Sciences

lida.dadshi1996@yahoo.com+98 41 3776 4273

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026