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Effect of Triphadi Chewing Gum in Oral Submucous Fibrosis(Sarvasara Mukha Roga)

An Open Labelled Randomized Controlled Clinical Study To Evaluate The Efficacy Of Triphaldi Chewing Gum In The Management Of Oral Submucous Fibrosis With Special Reference To Sarvasar Mukharoga - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101687
Enrollment
30
Registered
2026-01-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

None listed

Sponsors

Parul Institute of Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age group between 16 and 55 years 2. The patients having clinical signs and symptoms of OSMF. 3. The patients having normal premolar and molar teeth. 4. Patients presenting with the history of chewing gutkha, paan masala, areca nut for 1 or more than 1 year.

Exclusion criteria

Exclusion criteria: 1.Extensive fibrosis with severe trismus with an Inter Incisal Distance (IID) less than 15 mm 2. Disease is most advanced with premalignant and malignant changes 3. Generalized fibromatosis 4. Oral manifestation of scleroderma 5. Oral lichen planus 6. Pale oral mucosa of anaemia mimicking blanching 7. Chronic debilitating conditions such as DM, HT, HIV, etc. 8. Patients not willing to give up addiction habits of Gutka, Pan-Masala, tobacco, etc 9. Patients who do not have premolars and molars teeth

Design outcomes

Primary

MeasureTime frame
Relief from Trismus, burning sensation, intolerance to spicy foodTimepoint: 16th and 30th day

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDrSMd Nihaluddin

Parul Institute of Ayurveda

niddulahin@gmail.com9677049566

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026