UnknownNot Applicable

The Efficacy of Hibiscus Sabdariffa in Xerostomia

Egypt40 participantsStarted 2024-04-01

Plain-language summary

The goal of this \[ type of study: Clinical trial\] is to test effectiveness of Hibiscus Sabdariffa L. mouth rinse using the subjective dry mouth score as a primary objective and to assess the effect of that mix on the salivary flow rate and objective dry mouth score as a secondary objective.

Who can participate

Age range20 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Both genders, aged above 20 years. * All patients must have complaint of xerostomia. * Objective dry mouth score from ( 2-5). * Subjective dry mouth score from (1-4). * Patients must be able to make reliable decision or communications. Exclusion Criteria: * \- Smoking, Alcohol. * Patient with history of any serious illness as malignancy. * Patients with any autoimmune disease. * Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals. * Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.

What they're measuring

Subjective symptoms of oral dryness

Timeframe: Three points: -"baseline which is at the fourth week of radiotherapy", -"the second point is at seventh week of the radiotherapy, while the end point is after three months of radiotherapy.

Objective dry mouth score

Timeframe: Three points: -"baseline which is at the fourth week of radiotherapy", -"the second point is at seventh week of the radiotherapy, while the end point is after three months of radiotherapy.

Trial details

NCT IDNCT06413550

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01

Contact for this trial

Fatma E.Sayed A Hassanein, PHD

+201000093885 fatmahassanein@dent.asu.edu.eg

View on ClinicalTrials.gov More Radiation-induced Xerostomia trials

Who can participate

Age range20 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Subjective symptoms of oral dryness

Timeframe: Three points: -"baseline which is at the fourth week of radiotherapy", -"the second point is at seventh week of the radiotherapy, while the end point is after three months of radiotherapy.

Objective dry mouth score

Timeframe: Three points: -"baseline which is at the fourth week of radiotherapy", -"the second point is at seventh week of the radiotherapy, while the end point is after three months of radiotherapy.