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Evaluating the usefulness of Stressnil oral spray in treating patients with oral lichen planus

Therapeutic evaluation of Stressnil oral spray in the management of oral lichen planus- A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076160
Enrollment
34
Registered
2024-11-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Health Condition 1: L439- Lichen planus, unspecified Health Condition 2: K137- Other and unspecified lesions of oral mucosa

Interventions

Intervention1: Stressnil Anti-Antistress Oral spray: Stressnil oral spray is sprayed 5-6 times sublingually equivalent to 1 ml of the spray. The ingredients of the spray include Indian valerian 30mg,

Sponsors

Dr Fathima Mohammed Abdul Majeed
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Biopsy confirmed Oral lichen planus cases. 2) Age > 18 years.

Exclusion criteria

Exclusion criteria: 1. Patient 2. Patients who are pregnant and lactating. 3. Medically compromised patients undergoing treatment for all systemic conditions except for blood pressure and diabetes (COPD patients, chronic kidney disease patients, liver disorder patients, etc will be excluded from the study) 4. Patients with lichenoid drug reactions(caused by drugs like ACE inhibitors, beta-blockers, diuretics, etc) and that arise due to heavy metal restorations or any drugs. 5. Histologic signs of dysplasia. (participants who have malignancy/cancer and are under treatment for the same will be excluded from the study).

Design outcomes

Primary

MeasureTime frame
Reduction in the size of oral lichen planus lesion by visual assessment and photographic documentation. Reduction in symptoms/ burning sensation using NRS(numeric rating scale)Timepoint: Baseline, 1 week, 2 weeks, 3 weeks, and 4 weeks.

Secondary

MeasureTime frame
Reduction in the progression of lesion.Timepoint: 2 weeks & 4 weeks.

Countries

India

Contacts

Public ContactDr Prashanth Shenoy

Yenepoya Dental College And Hospital

prashanthshenoy4@gmail.com9845082753

Outcome results

None listed

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