Comparing The Effect Of Herbal Extract With Gold Standard Drug For Treatment Of Homogenous Leukoplakia
Phase 2
Completed
- Conditions
- Health Condition 1: null- HOMOGENOUS LEUKOPLAKIAHealth Condition 2: K132- Leukoplakia and other disturbancesof oral epithelium, including tongue
- Registration Number
- CTRI/2021/04/032895
- Lead Sponsor
- Manisha Singh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
Inclusion Criteria
Tobacco induced, clinically diagnosed, histopathologically confirmed cases of homogeneous leukoplakia measuring not less than 1.5 cm in area bidimensionally.
Age group 20 to 60 years.
Patients willing to participate in the study.
Exclusion Criteria
Patients with potentially malignant disorders other than homogeneous leukoplakia.
Past history of major illness within a period of 6 months.
Patients with known allergy to Asterceae family
Patients with known allergy to lycopene
Pregnant and Lactating females.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Increase/decrease in the size of the lesionTimepoint: 1 and half year
- Secondary Outcome Measures
Name Time Method o change in the size of lesionTimepoint: 1 and half year
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Calendula officinalis extract's efficacy in treating tobacco-induced Homogenous Leukoplakia compared to Lycopene gel?
How does CTRI/2021/04/032895's Calendula officinalis extract compare to Lycopene gel in clinical endpoints for K132 oral epithelial disturbances?
Which biomarkers correlate with treatment response to Calendula officinalis or Lycopene in tobacco-associated leukoplakia management?
What adverse events were reported in Phase II trials of Calendula officinalis extract versus Lycopene gel for Homogenous Leukoplakia?
Are there alternative herbal compounds or combination therapies targeting oral leukoplakia with mechanisms similar to Lycopene or Calendula officinalis?