The Efficacy of Hibiscus Sabdariffa in Xerostomia

Trial Title: The Efficacy of Hibiscus Sabdariffa in Xerostomia

NCT ID: NCT06413550

Condition: Radiation-induced Xerostomia

Conditions: Official terms:
Xerostomia

Conditions: Keywords:
xerostomia
Hibiscus Sabdariffa
Radiation

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Biological
Intervention name: Hibiscus Sabdariffa
Description: 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].
Arm group label: Control group
Arm group label: Intervention group

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.

Detailed description: Xerostomia, defined as the subjective complaint of dry mouth, is one of the most prevalent and challenging adverse effects for head and neck cancer (HNC) patients treated with radiotherapy (RT) in definitive or adjuvant setting with or without concomitant chemotherapy (CHT). It represents a toxicity that can resolve over time, but often translates into a permanent condition that seriously affects swallowing, speaking and oral health, impairing several domains of patients' quality of life (QoL). Symptomatically, xerostomia may range from mild discomfort to severe oral disease accompanied by signs and symptoms affecting the oral cavity, including mucous membranes, lips, tongue, salivary glands and teeth. In the most severe cases it can cause severe depression. Although radiation-induced xerostomia (RIX) is multifactorial, it is primarily the consequence of damage to the major and minor salivary glands that are usually included in the radiation fields or are in their close proximity. Thus, the severity of glandular injury and potential for recovery depends on the irradiated gland volume, the cumulative radiation dose and the capability of surviving cells to repopulate. Such injury causes diminution in function of the salivary glands and the consequences are reduction in saliva volume, consistency, pH, immunoglobulins and antimicrobial proteins. The efficacy of Aqualief in treating xerostomia, or dry mouth, in patients contacting a randomized, placebo-controlled, double-blind trial was evaluated by a previous study. Aqualief contains two key ingredients, carnosine and karkadé (Hibiscus sabdariffa), which were selected and mixed with normalizing saliva pH and increasing saliva buffering activity. These parameters are often impaired in xerostomia patients, leading to acid-induced enamel and dental erosion and promoting the growth of aciduric bacteria. Aqualief was found to normalize saliva pH to a neutral value and significantly increase the saliva flow rate in xerostomic patients. After six days of treatment, saliva pH was increased toward a neutral value, and the saliva flow rate was increased by almost 60%, compared to the basal value. This improvement was more than three times greater than that achieved with a placebo, which only increased resting salivation by 19%.

Criteria for eligibility:
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.

Gender: All

Minimum age: 20 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Ahmed Maher Teaching Hosipital

Address:
City: Cairo
Zip: 11565
Country: Egypt

Status: Recruiting

Contact:
Last name: Fatma E.Sayed A Hassanein

Phone: +201000093885
Email: fatmahassanein@dent.asu.edu.eg

Start date: April 1, 2024

Completion date: March 2025

Lead sponsor:
Agency: Ain Shams University
Agency class: Other

Source: Ain Shams University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06413550