Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413550
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-19
Brief Title:
The Efficacy of Hibiscus Sabdariffa in Xerostomia
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
The Efficacy of Hibiscus Sabdariffa L Mouth Rinse in Head and Neck Cancer Patients With Xerostomia A Randomized Placebo-Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None