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Clinical Trials/CTRI/2016/04/006827
CTRI/2016/04/006827
Active, not recruiting
Phase 4

â??Evaluation of short term treatment outcome after systemic lycopene therapy versus cryotherapy in management of oral leukoplakia: - a randomized parallel group trial.

All India Institute of Medical Sciences0 sites100 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- Patient with biopsy proven cases of oral leukoplakia
Sponsor
All India Institute of Medical Sciences
Enrollment
100
Status
Active, not recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • All healthy male and female between 15\-60 years having oral leukoplakia (biopsy proven) reporting to department of oral and maxillofacial surgery , CDER AIIMS
  • 2\. Patients having size of primary lesion more than 1 cm.
  • 3\. Patient having history of tobacco chewing/smoking.

Exclusion Criteria

  • 1\.Patient having white lesion with negative history of tobacco use.
  • 2\.Patients with lesion of size less than 1 cm.
  • 3\.Patients with lesion associated with ulcero\-proliferative growth or suspicious of squamous cell carcinoma.
  • 4\.Patients who are nursing or pregnant.
  • 5\.Patients with uncontrolled systemic disease.
  • 6\.Patient who are allergic to tomato and food products containing tomato extracts.
  • 7\.Patient not willing to quit the adverse habit.
  • 8\.Patient refuses to give consent.

Outcomes

Primary Outcomes

Not specified

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