Clinical trial
The Efficacy of Hibiscus Sabdariffa L. Mouth Rinse in Head and Neck Cancer Patients With Xerostomia: A Randomized, Placebo-Controlled Clinical Trial
Name
Xerostomia & Hibiscus
Description
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.
Trial arms
Trial start
2024-04-01
Estimated PCD
2025-01-01
Trial end
2025-03-01
Status
Recruiting
Treatment
Hibiscus 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 \[20\].
Arms:
Control group, Intervention group
Size
40
Primary endpoint
Subjective symptoms of oral dryness
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
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.
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-05-14
1 organization
1 product
1 indication
Organization
Ain Shams UniversityProduct
Hibiscus SabdariffaIndication
Xerostomia