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Turmeric in oral submucous fibrosis.

Clinical efficacy of curcumin in the management of oral submucous fibrosis patients: A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009461
Enrollment
150
Registered
2017-08-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Oral submucous fibrosis

Interventions

Intervention1: Tablet Turmix (tablet containing curcumin 300 mg and piperine 5 mg, Sanat products limited) 3 times per day for 3 months along with turmix mouthwash (Sanat products limited) three times

Sponsors

Jamia Millia Islamia
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients satisfying all the inclusion criteria were enrolled which included current or previous use of any form of smokeless tobacco and/or areca nut (any duration and frequency); complains of burning sensation of mouth on having hot and spicy food and/or difficulty in swallowing and chewing; and presenting with clinical features like restricted mouth opening and/or changes in the oral mucous membrane including presence of vertical fibrous bands, stiffness, blanching and circum oral bands.

Exclusion criteria

Exclusion criteria: Patients with significant medical condition as defined by the investigator that interfered with the safety, treatment or compliance with the protocol; patients with known allergy or contra-indication to any of the ingredients of the antioxidants or turmeric; pregnant and lactating females; patients already undergoing treatment for OSMF and patients having concomitant pericoronitis or any other dental condition leading to trismus were excluded from the study.

Design outcomes

Primary

MeasureTime frame
The primary outcomes studied were inter-incisal mouth opening; tongue protrusion and burning sensation on having food was recorded using Visual Analogue Scale (VAS) from 1 to 10 (with 10 being the most severe).Timepoint: every 15 days for 3 months

Secondary

MeasureTime frame
The secondary outcomes studied were adverse reactions reported with the drugs used; habit cessation success rate and change in the color of mucosa (recorded as white, pale or pink).Timepoint: every 15 days for 3 months

Countries

India

Contacts

Public ContactArpita Rai

Jamia Millia Islamia

arai@jmi.ac.in

Outcome results

None listed

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