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Black seed cream for reduction of patients burning sensation and white patches in mouth

â??Comparative evaluation of the efficacy of Nigella sativa (75%) (w/v) cream and Clobetasol propionate (0.05%) ointment for the management of Oral Lichen Planus- a double blinded randomized control trialâ??

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026745
Enrollment
72
Registered
2020-07-23
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: L438- Other lichen planus

Interventions

Intervention1: Nigella sativa(Black seed) 75% (w/v) cream: Topical application of the cream on the oral mucosa twice daily after breakfast and dinner for 60 days will be advised. Sufficient quantity o

Sponsors

DR LOKESH KUMAR S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients clinically diagnosed with Oral Lichen planus (according to Andreason criteria) with fine white radiating striae bilaterally along with burning sensation. 2. Patients above 18 years. 3. Patients who are willing to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Patients with any other potentially malignant disorders other than Oral Lichen Planus and under treatment for the same. 2. Patients who are allergic to Clobetasol propionate and Nigella sativa (Black seed) topical preparation. 3. Patients with any other systemic disease. 4. Pregnant and lactating females. 5. Patients who have already undergone treatment for Oral Lichen planus (within 3 months)

Design outcomes

Primary

MeasureTime frame
Reduction in the intenstity of burning sensation and reduction in the size of the lesion.Timepoint: 15 days, 30 days, 45 days, 60 days

Secondary

MeasureTime frame
Whether Nigella sativa 75% (w/v) cream can or cannot be used as an alternative treatment modality for the management of Oral Lichen Planus and whether it has comparable effects of Clobetasol propionate will be knownTimepoint: 15 days, 30 days, 45 days, 60 days

Countries

India

Contacts

Public ContactDr Lokesh Kumar S

KLE VISHWANATH KATTI INSTITUTE OF DENTAL SCIENCES, KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH

drznaik@gmail.com9448854710

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 12, 2026