The Efficacy of Hibiscus Sabdariffa in Xerostomia

NCT06413550 | Recruiting DMC

• 1 other identifier: Xerostomia & Hibiscus
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation-induced Xerostomia

Keywords

xerostomia; Hibiscus Sabdariffa; Radiation

Outcome Measures

Primary Outcomes (2)

• Subjective symptoms of oral dryness

  • Using a questionnaire will be recorded according to the following: Q1. Does your mouth feel dry? Q2. Do you sip liquids to aid in swallowing dry food? Q3. Does your mouth feel dry when eating a meal? Q4. Does the amount of saliva in your mouth seem to be too little? Subject who answered affirmatively to at least one of the questions related to oral dryness will be considered as positive for subjective complaints of oral dryness and take score from 1-4 according to the number of positive answers.

  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

  * The patients will be examined for their signs of dry mouth including: 1. loss of pooled saliva 2. Mouth mirror stickiness 3. Stringy or foamy appearance 4. Labial dehydration 5. Irresponsiveness to parotid stimulation * Objective dry mouth scores will be calculated as the number of observed dry mouth signs (0-5), and patients with a score less than 2 will be excluded.

  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.

Secondary Outcomes (1)

• Salivary flow rate

  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.

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Biological: Hibiscus Sabdariffa

Control group

PLACEBO COMPARATOR

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.

Biological: Hibiscus Sabdariffa

Interventions

Hibiscus Sabdariffa BIOLOGICAL

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 \[20\].

Control group; Intervention group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ahmed Maher Teaching Hosipital

Cairo, 11565, Egypt

RECRUITING

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• dalia Ghalwash

  professor

  STUDY DIRECTOR

Central Study Contacts

Fatma E.Sayed A Hassanein, PHD

CONTACT

+201000093885; fatmahassanein@dent.asu.edu.eg

Asma A. Abou Bakr

CONTACT

Asmaa.Aboubakr@bue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 14, 2024
• Study Start: April 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)