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

Evaluation of the effect a herbal lozenge tablet containing ginger, green tea, hollyhock, and mallow and on saliva secretion by measuring the difference in the weight of secreted saliva before and after taking the pill; in healthy volunteers.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221229056981N1
Enrollment
25
Registered
2023-04-15
Start date
2023-04-24
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Xerostomia. Disturbances of salivary secretion

Interventions

First intervention group: The lozenge used contains 500 mg of xylitol, 200 mg of green tea extract, 200 mg of ginger extract, 100 mg of marshmallow extract, and 100 mg of cheese extract. This lozenge

Sponsors

Alborz University Of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Mahdi Ahmadian-Attari

Alborz University of Medical Sciences

ahmadian.attari@gmail.com+98 26 3256 7175

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026