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Use of curcumin and lycopene in the treatment for oral submucous fibrosis

Efficacy of curcumin and lycopene in the treatment for oral submucous fibrosis - A double blinded randomized clinical trial - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055584
Enrollment
102
Registered
2023-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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

Intervention1: Curcumin: 300mg of curcumin is given thrice daily for 3 months and the patient is followed up at 15 days regular intervals. Control Intervention1: Lycopene: 20000mcg of lycopene is give

Sponsors

Sardar Patel Post Graduate Institute of Dental and Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1- Clinically diagnose case of OSMF 2- Patients who are willing for participation 3- Patients between the age group of 18 to 80 years of age

Exclusion criteria

Exclusion criteria: 1- Patients below 18 years of age. 2- Any development anamolies like bifid uvula, cleft palate. 3- Any syndromic cases. 4- Trismus due to other causes like abscess, space infections. 5- Restricted mouth opening due to trauma, impacted teeth, TMJ pathologies. 6- Patients who have undergone any surgical treatment like surgeries for carcinoma or any other surgery. 7- Patient with history of radiotherapy. 8- Pregnant females. 9- Patient who are not willing to participate. 10- Patient with known allergy to curcumin & lycopene

Design outcomes

Primary

MeasureTime frame
Lycopene and curcumin could be considered be a safe and effective therapeutic modality for patients with a chronic condition like OSMF. The primary outcome is to see which is more effective.Timepoint: Baseline 1 months 3 months 6 months

Secondary

MeasureTime frame
To observe any efficacy of these drugs among genders & at different age groups Timepoint: Baseline 2 weeks 4 weeks 8 weeks 6 months

Countries

India

Contacts

Public ContactAnjali yadav

Sardar patel post graduate institute of dental and medical sciences

dr.abhisheksinha.mds@gmail.com8948116600

Outcome results

None listed

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