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"Turmeric as an additive agent to treat Fibrosis of cheeks"

"Evaluate the efficacy of Curcumin & Piperine as an antioxidant adjuvant to intralesional dexamethasone injections in the management of Oral Submucous Fibrosis"

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/07/006001
Enrollment
40
Registered
2015-07-15
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: L00-L99- Diseases of the skin and subcutaneous tissue Health Condition 2: null- Oral Submucous Fibrosis

Interventions

Intervention1: injection Dexamethasone and tablet Curcumin: Intralesional dexamethasone sodium phosphate 4mg/ml injection biweekly and tablet Turmix(Curcumin & Piperine tablet) 300mg thrice daily ora

Sponsors

Dr Nilima Sharma
Lead Sponsor
Sanat Products Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex above 20 years of age. A positive history of chewing arecanut or one of its commercial preparations. Diagnosis of OSMF was made on the basis of natural history and characteristic clinical features which included the presence of burning sensation in the mouth, intolerance to spicy food, blanching and loss of suppleness of oral mucosa, presence of palpable fibrous bands and decreased mouth opening.

Exclusion criteria

Exclusion criteria: Patients with chronic illnesses and systemic diseases(diabetes, hypertension, liver disorders, kidney disorders, autoimmune disorders), other mucosal lesions. Pregnant and lactating women. Patients with a known allergy or contraindication to the study drugs. Malignancy Temporomandibular joint arthrosis , Fracture mandible ramus

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of curcumin as an antioxidant adjuvant to corticosteroid injections in the management of oral submucous fibrosis.Timepoint: Every month

Secondary

MeasureTime frame
1. Resumption of normal eating, chewing and speech. 2. Change or improvement in maximal jaw opening, measuredas the interincisal distance. 3. Reduction in fibrosis evaluated by pre and post treatment ultrasonography. 4. Change in severity of oral/mucosal burning pain using Visual Analogue Scale validated pain scale. Timepoint: every 4 days for 3 months

Countries

India

Contacts

Public ContactDrNilima Sharma

Hamdard Institute of Medical Sciences and Research

nilimasharma@yahoo.com9873229685

Outcome results

None listed

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