Health Condition 1: K029- Dental caries, unspecified Health Condition 2: R196- Halitosis
Conditions
Interventions
None listed
Sponsors
Shrushti Pharma
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients aged 18 65 years. 2.Dental Caries. 3.Patient of Toothache. 4.Willingness to participate with signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Systemic disorders (uncontrolled diabetes, tuberculosis, HIV, malignancies). 2.Patients with malignant or premalignant oral conditions. 3.Drug allergy to any Khadiradi Gutika ingredient. 4.Pregnant or lactating women. 5.Long-term corticosteroid or immunosuppressive therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in toothache severity (VAS Score) from baseline to end of treatment. Timepoint: Day 1 (baseline), Day 5, Day 10, and Day 15 (final assessment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite score of symptoms such as:pain swelling sensitivity halitosisTimepoint: Day 1 (Baseline): Administration of Khadiradi Gutika; baseline assessment of toothache severity (VAS), clinical signs, and oral examination. Day 5 (Follow-up 1): Assessment of symptomatic relief using VAS score; evaluation of tenderness, swelling, halitosis and any adverse events. Day 10 (Follow-up 2): Assessment of persistence or further improvement of symptoms; clinical evaluation for healing and monitoring for adverse events. Day 15 (Follow-up 3 / Final Assessment): Final assessment of toothache severity (primary endpoint), clinical signs, recurrence of symptoms, compliance, and safety evaluation. | — |
Countries
India
Contacts
Public ContactDr Akash SToshniwal
Shrushti Pharma
Outcome results
None listed