Health Condition 1: null- Halitosis
Conditions
Interventions
Intervention1: â??AHPL/AYTAB/1514â?? Tablet
: Contains Haridra (Curcuma longa), Pippali (Piper longum) and Putiha (Mentha arvensis)
Dosage and treatment duration: All study subjects will receive 2 t
Sponsors
Ari Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male and female subjects of age between 18-54 years 2.Subject willing to participate in clinical trial and who have read, understood and signed informed consent form 3.Subjects suffering from moderate to severe halitosis analyzed on Bad Breath Analyzer 4.Subjects not suffering from severe gingival diseases
Exclusion criteria
Exclusion criteria: 1.Subjects who had destructive periodontal disease or who had undergone a periodontal surgery in the past three months will be excluded from the study 2.Subjects with Loe and Silness gingival index score 3 3.Subjects with Turesky modification of Quiely Hein index score of more than 4 4.Subject who used antibiotic, antimicrobial, analgesic medications, mouthwash, mouth fresheners or desensitizing toothpaste during the previous 1 month 5.Subject having any history of dentine hypersensitivity treatment 6.Subject having any removable device such as a removable partial denture or orthodontic retainer 7.Subject having presence of any �xed appliance, large or defective restorations, cracked enamel 8.Subjects with any medically compromised conditions contraindicating the oral examination 9.Patients with preexisting systemic disease necessitating long-term medications, genetic and endocrinal disorders 10.Subjects with significant abnormal laboratory parameters 11.ECG demonstrating any signs of uncontrolled arrhythmia acute ischemia and X ray chest showing any active lesion of tuberculosis 12.Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate effect of AHPL/AYTAB/1514 tablet in halitosis using Bad breath analyzer and on organoleptic assessment scaleTimepoint: Screening visit, Day o, Day 15, Day 30, Day 45, Day 60 and Day 75 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment of Gingivitis 2.Assessment of dental plaque 3.Assessment of intensity of Sore throat 4.Assessment of intensity of Cough 5.Assessment of acceptability of trial drug 6.Assessment of incidence and severity of infections 7.Assessment of Quality of Life 8.Assessment of overall treatment satisfaction by patient and physician 9.Assessment of drug compliance 10.Assessment of adverse events 11.Assessment of changes in laboratory parametersTimepoint: Screening visit, Day o, Day 15, Day 30, Day 45, Day 60 and Day 75 | — |
Countries
India
Contacts
Public ContactDr Sanjay Nipanikar
Ari Healthcare Pvt. Ltd.
Outcome results
None listed