Health Condition 1: R196- Halitosis
Conditions
Interventions
Intervention1: Hariras Ayurvedic Pills: One Hariras Ayurvedic pills 08 to 10 times per day for seven days.
Control Intervention1: NIL: NIL
Sponsors
Sushrutkrupa Ayurvedic Pharmacy Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 55 years (both inclusive) at the time of consent. 2. Sex: Healthy male and non-pregnant/non-lactating females. 3. Females of childbearing potential must have a negative urine pregnancy test performed on screening. 4. Subjects are in good general health as determined by the Investigator based on medical history. 5. Subjects having clinically relevant mouth malodor evident by Halimeter. 6. Subjects should be willing and able to follow the study directions to participate in the study. 7. Subject willing to come to study site without brushing and can stay for 6 hrs. for assessment of oral malodor.
Exclusion criteria
Exclusion criteria: 1. Subjects with orthodontic bands. 2. Subjects with plaque index of 0, 1 and 5 3. Subjects with partial removable dentures. 4. Subjects having tumor(s) of the soft or hard tissues of the oral cavity. 5. Subjects with advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone) 6. Subjects with ongoing antibiotic treatment at the time of screening. 7. Subjects having participated in any other dental clinical study within the last six months prior to entry into the study. 8. Subjects with dental prophylaxis during the past two weeks prior to baseline examinations. 9. Subjects with a history of allergies to any oral care/personal care consumer products or their ingredients. 10. Subjects on any prescription medicines that might interfere with the study outcome. 11. Pregnant and lactating women. 12. Subjects habitual to consumption of any medicated sweets, chewing gum, breath fresheners, etc. containing antimicrobial agents. 13. Subjects with diseases or having a history that potentially can contribute to oral malodor (e.g. diabetes mellitus, bronchitis, tonsillitis, sinusitis etc.) 14. Subjects habitual consumption of alcohol, tobacco, and smoking cigarettes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the effect of the test product on malodor control using a Halimeter from screening to end of the study. 2.Changes in subject-reported freshness score on 5-point scale from screening to end of the study. Timepoint: At Screening, Baseline, Day 1, Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactMr Manish Jayatilal Bhardwaj
Sushrutkrupa Ayurvedic Pharmacy Pvt. Ltd.
Outcome results
None listed