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A study to compare the effects of Triphaladi Kashaya in gel form versus Triphaladi Kashaya used as a gargle in patients with mouth ulcers.

A Comparative clinical trial on the ulcer healing effect of Triphaladi kashaya in gel form against its Kashaya gandusha in Minor recurrent aphthous stomatitis. - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083172
Enrollment
38
Registered
2025-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: K120- Recurrent oral aphthae

Interventions

None listed

Sponsors

Afiya M Shoukkath
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Participants with history of Recurrent Aphthous Stomatitis occurring at least thrice a year. 2.Diagnosed cases of hematinic deficiencies which are resistant to standard systemic treatment modalities. 3.Participants with clinical features of Minor Recurrent Aphthous Stomatitis diagnosed with the help of a Dentist in Government Ayurveda Medical College Hospital Tripunithura.

Exclusion criteria

Exclusion criteria: 1.Participants taking systemic antibiotics, non-steroidal anti-inflammatory drugs, or local medications within 1 month before the study. 2.Ulcers measuring more than 10mm in diameter. 3.Traumatic stomatitis. 4.Diagnosed non healing ulcers associated with other systemic diseases.

Design outcomes

Primary

MeasureTime frame
Ulcer severity score: 1.Number of ulcers. 2.Size of ulcers. 3.Pain. 4.Average duration of ulcers. 5.Ulcer-free period. 6.Mucosal site.Timepoint: Ulcer severity score will be assessed using a grading method on the 0th,5th,10th,15th,45th days of the study.

Secondary

MeasureTime frame
Composite index for oral ulcer: 1.Oral ulcer activity. 2.Pain status. 3.Functional status. a)Unpleasant taste. b)Difficulty in speaking. c)Difficulty in eating/chewing/swallowing.Timepoint: Composite index for oral ulcers will be assessed on the 0th day and 45th day of the study.

Countries

India

Contacts

Public ContactDr Noble T M

Government Ayurveda Medical College, Tripunithura.

drnobletm@gmail.com9400829878

Outcome results

None listed

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