RecruitingNot ApplicableNCT06413550

The Efficacy of Hibiscus Sabdariffa in Xerostomia

The Efficacy of Hibiscus Sabdariffa L. Mouth Rinse in Head and Neck Cancer Patients With Xerostomia: A Randomized, Placebo-Controlled Clinical Trial

Sponsor

Ain Shams University

Enrollment

40 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Radiation-induced Xerostomia

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.

Eligibility

Min Age: 20 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether Hibiscus sabdariffa (a herbal plant extract commonly used in teas) can help relieve dry mouth (xerostomia) — a condition where the mouth does not produce enough saliva, making it difficult to eat, speak, and swallow. **You may be eligible if...** - You are over 20 years old (any gender) - You experience significant dry mouth symptoms - Your dry mouth is confirmed by both a score on a clinical scale and a subjective symptom score - You are able to make informed decisions and communicate your experience **You may NOT be eligible if...** - You smoke or drink alcohol - You have or had cancer - You have an autoimmune disease - You are pregnant - You have a known allergy to the study treatment - You are in a vulnerable group (prisoners, people with serious physical or intellectual disabilities) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHibiscus Sabdariffa

The fresh red Roselle plant was obtained; the red calyxes of Hibiscus Sabdariffa were separated from the plant and dried for a week at 25°C. The dried calyxes were ground to powder, kept in a sealed container, and stored in a refrigerator (4°C) until used. Aqueous Roselle calyx extract was prepared by adding 10 gm of the previously prepared powder to 100 ml of boiling water and then heated on a hot stirrer plate for 30 min. To remove the remnants, the mixture was filtered via Whatman No 1 filter paper (Whatman products, Springfield Paper Mill, Maidstone, UK). The water content of the filtered solution was evaporated using an air recirculation oven and then kept at 4°C in the dark until used to determine antibacterial effectiveness \[20\].

Locations(1)

Ahmed Maher Teaching Hosipital

Cairo, Egypt

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NCT06413550

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