Health Condition 1: L439- Lichen planus, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes. 2. Patients above 18 years of age. 3. Patients diagnosed to be suffering from OLP on the basis of clinical and histopathological examination. 4. Patients who are willing to give informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Patients who are suffering from another acute or chronic diseases of the oral mucosa. 2. Patients who are taking any kind of Allopathic, Ayurvedic or Unani medical treatment or patients who had therapy for OLP within last 4 weeks will be excluded. 3. Patients who are immune-compromised and/or suffering from critical illness like hepatic diseases, renal diseases, HIV etc. and who have any congenital defect. 4. Patients who are suffering from any cancer specially oral cancer. 5. Pregnant or nursing women will be excluded from the study. 6. Patients who are unwilling to give informed consent to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ï?¶ The outcome of main interest or the primary outcome is change in severity of OLP. ï?¶ Metric/method of measurement: VAS for pain intensity and Escudier Disease Severity Score ï?¶ Participant level Analysis Metric: The outcome value at one year from the baseline will be used for statistical analysis. ï?¶ Time point of primary interest: The scale measurement will be taken at baseline and at every follow up. The subject if be lost to follow up then the last available value will be considered Timepoint: ï?¶ Outcome will be assessed/estimated at baseline and at every one month for the period of 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| ï?¶ The secondary outcome measure is general outcome of the patient after treatment and change in oral health related QoL of the patient. ï?¶ Metric/method of measurement: OHIP- 14, relevant laboratory investigations, progress of the case as per signs and symptoms, ORIDL score by the investigator and MYMOP2 score by the patient. ï?¶ Time point of primary interest: Relevant investigations will be done at the baseline and at the end of treatment or as when required. Timepoint: 20 months | — |
Countries
India
Contacts
Central Council for Research in Homoeopathy