Evaluation of the effect a herbal lozenge tablet containing ginger, green tea, hollyhock, and mallow and on saliva secretion in healthy volunteers.

Phase 2

Recruiting

• Conditions: Xerostomia.; Disturbances of salivary secretion; K11.7

• Registration Number: IRCT20221229056981N1
• Lead Sponsor: Alborz University Of Medical Science

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Participants should be 18 years old or older. And people over 60 years old or older should not participate in the study.
2. Candidates should not be patient, especially diseases which are regarded to salivary glands and oral mucosa.
3. Participants should not have dry mouth or dry eyes.
4. Participants must be able to read, complete and sign the consent form. They should also be able to understand and answer the questionnaire.

Exclusion Criteria

1. Intolerance to taking pills during the test and unwillingness to continue working.
2. People who answer yes to the questions about dryness. These people are considered positive for dry mouth and cannot participate in the study.
3. Lactating women and pregnant women.
4. Participants who complain of dry mouth or dry eyes.
5. Patients with oral lesions or other contact sensitivities.
6. Patients suffering from autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus or progressive systemic sclerosis, because people with these autoimmune inflammatory diseases show persistent dry mouth.
7. People with acute or chronic use of drugs that cause dry mouth. Which includes drugs such as antihistamines, antipsychotics, antidepressants and etc.
8. Patients undergoing radiotherapy (mainly for the treatment of head and neck cancer).
9. People with chronic disease, if it is not well controlled.
10. People with HIV, hepatitis B or hepatitis C infection.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The amount of saliva secretion. Timepoint: Before and after taking the lozenge. Method of measurement: By cotton weighing. In this way, before taking the lozenge, cotton it is placed in the volunteer's mouth and then it is weighed. The same process is repeated after taking the lozenge. Then, the difference in the weight of the cottons, which shows the increase in saliva secretion, is calculated.;Organoleptic characteristics. Timepoint: Immediately after taking the pill. Method of measurement: Statistical analysis is done based on scoring the questionnaire regarding organoleptic characteristics. The questionnaire is evaluated in the form of scoring. Scores are analyzed statistically by Anova method.