The Efficacy of Hibiscus Sabdariffa in Xerostomia

Ain Shams University

Status: Enrolling

Conditions: Radiation-induced Xerostomia

Treatments: Biological: Hibiscus Sabdariffa

Study type: Interventional

Funder types: Other

Identifiers

NCT06413550

Xerostomia & Hibiscus

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

patients in test group will topically apply 20 mL of Hibiscus Sabdariffa L. to the oral mucosa as oral rinse 3 times per day. Patients were advised to rinse 20 mL of Hibiscus Sabdariffa L. from the fourth week of radiotherapy to three months after radiotherapy.

Treatment:

Biological: Hibiscus Sabdariffa

Control group

Placebo Comparator group

Description:

Patients in the control arm will topically apply 20 mL of 0.9% of normal saline rinses 3 times per day. Patients were advised to rinse with 20 mL normal saline from the fourth week of radiotherapy to three months after radiotherapy.

Treatment:

Biological: Hibiscus Sabdariffa