Testing Hibiscus Sabdariffa for Dry Mouth Relief
The Efficacy of Hibiscus Sabdariffa L. Mouth Rinse in Head and Neck Cancer Patients With Xerostomia: A Randomized, Placebo-Controlled Clinical Trial
This study is testing if a mouth rinse made from Hibiscus Sabdariffa can help people with dry mouth, especially those who have had radiation treatment for head and neck cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06413550 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Hibiscus Sabdariffa L. mouth rinse in alleviating xerostomia, particularly in patients who have undergone radiotherapy for head and neck cancer. The primary objective is to measure subjective dry mouth scores, while secondary objectives include assessing changes in salivary flow rates and objective dry mouth scores. The study will involve patients who report dry mouth symptoms and will exclude those with certain health conditions or sensitivities. The trial is conducted at Ahmed Maher Teaching Hospital in Cairo.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old who experience xerostomia with specific dry mouth scores.
Not a fit: Patients with serious illnesses, autoimmune diseases, or those who are pregnant or vulnerable may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from radiation-induced dry mouth.
How similar studies have performed: While there have been studies on various treatments for xerostomia, the specific use of Hibiscus Sabdariffa for this condition is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cairo
- Ahmed Maher Teaching Hosipital — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Fatma E.Sayed A Hassanein, PHD
- Email: fatmahassanein@dent.asu.edu.eg
- Phone: +201000093885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.