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A 4-week, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of HH-203M in reducing halitosis

A 4-week, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of HH-203M in reducing halitosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0012209
Enrollment
100
Registered
2026-07-01
Start date
2026-07-06
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

None listed

Interventions

Dietary Supplement : Participants will be randomly assigned to either the test group or the control group and will consume the test food or control food once daily for 4 weeks. One tablet will be take

Sponsors

Hecto Healthcare
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults aged 19 to 70 years at the time of screening. 2) Participants with a score of =2 on the organoleptic test for halitosis. 3) Participants with hydrogen sulfide (H2S) levels of =112 ppb and methyl mercaptan (CH3SH) levels of =26 ppb. 4) Participants who agree not to undergo periodontal treatment during the study period. 5) Participants who voluntarily provide written informed consent to participate in the study and are able to understand and comply with the study procedures.

Exclusion criteria

Exclusion criteria: 1) Participants who have undergone scaling within 3 months or periodontal treatment within 6 months prior to the screening visit, or who are expected to require dental treatment during the study period. 2) Participants who are currently receiving treatment for or have a history of the following conditions (however, participation may be permitted at the discretion of the Principal Investigator based on the participant's clinical condition): ?Uncontrolled systemic diseases that may affect halitosis ?Untreated severe dental diseases ?Uncontrolled hypertension ?Uncontrolled diabetes mellitus or current insulin therapy ?Active upper respiratory tract disease ?Active or symptomatic gastrointestinal disease ?Psychiatric disorders 3) Participants who have taken any of the following medications, health functional foods, or foods within 2 weeks prior to the screening visit: ?Medications that may affect the oral microbiota ?Medications that reduce salivary secretion ?Psychotropic medications ?Sodium-glucose cotransporter-2 (SGLT2) inhibitors ?Products containing the same or similar ingredients as the investigational product 4) Participants who have taken any of the following medications, health functional foods, or foods within 1 week prior to the screening visit: ?Systemic medications that may affect halitosis ?Products intended to alleviate halitosis 5) Participants currently using inhaled bronchodilators or inhaled corticosteroids. 6) Participants with known hypersensitivity, allergy, or adverse reactions to any ingredients contained in the investigational product or control product. 7) Participants who have participated in another clinical trial or human study within the previous 3 months, or who plan to participate in another study during the study period (participants in observational studies involving no administration of drugs or foods [e.g., injection, ingestion, or insertion] are eligible). 8) Participants who are pregnant or breastfeeding, or who plan to become pregnant during the study period. 9) Participants with a history of drug abuse or suspected drug dependence. 10) Participants who work night shifts or have irregular bedtime schedules due to occupational or other reasons. 11) Participants with excessive alcohol consumption. 12) Heavy smokers. 13) Participants whom the Principal Investigator considers unsuitable for participation based on clinical laboratory test results or any other reason.

Design outcomes

Primary

MeasureTime frame
Oral volatile sulfur compound (VSC) concentrations

Secondary

MeasureTime frame
Tongue coating index;Plaque index;Oral microbiota;Subjective improvement of halitosis;Halitosis-related discomfort questionnaire;Matrix metalloproteinases;Safety assessments

Countries

Korea, Republic of

Contacts

Public ContactYENA LEE

Hallym University Medical Center

gagaga1017@naver.com+82-31-380-1513

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jul 23, 2026