To test the effect of Zinobliss gel for treating Oral Ulcers
- Conditions
- Health Condition 1: K123- Oral mucositis (ulcerative)
- Registration Number
- CTRI/2023/02/049982
- Lead Sponsor
- Puneet Laboratories Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
1. Male or female patients greater than 18 years of age diagnosed with oral mucositis, Stomatitis, Lichen Planus, Submucosal Fibrosis, Erythroleukoplakia, Mouth ulcer due to Nutritional deficiency or after radiotherapy
2. Negative pregnancy test within 2 weeks prior to registration for women of Childbearing potential.
3. Ability to understand and willingness to sign a written informed consent document with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
1. History or presence of significant:
- Cardiovascular, pulmonary, hepatic, renal, haematological,
gastrointestinal, endocrinal, immunologic, dermatologic, neurological or psychiatric disease.
2. Alcohol dependence, alcohol abuse or drug abuse within the past one
year
3. History of known allergic reactions attributed to compounds of similar chemical composition to Zinc or Lignocaine or triamcinolone or chlorhexidine or other chemotherapy drugs.
4. Known history of HIV infection, or active hepatitis B, or hepatitis C infection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Reduction of oral and pharyngeal pain before and 60 min. after administration of test drugs- measured on Visual Analogue Scale (VAS) . [time frame: 10 days] <br/ ><br>2.Healing of Mucositis/stomatitis (assessed by investigator- with photographs and measurement of the lesion) [time frame: 10 days] <br/ ><br>3.Incidence & duration of treatment-emergent xerostomia. [time frame: 10 days] <br/ ><br>4.Incidence & duration of Taste disturbance, Oral irritation / Burning sensation and teeth staining. [time frame: 10 days] <br/ ><br>5.Use of rescue medication (analgesics) for pain. [time frame: 10 days] <br/ ><br>6.Incidence of need for a modified diet (soft, liquid, TPN) [ Time Frame: 10 days ]Timepoint: Baseline and End of Study (10 days)
- Secondary Outcome Measures
Name Time Method Impact of the treatment on activities of daily living [ Time Frame: 10 days ] via a validated oral mucositis daily questionnaire (OMDQ) <br/ ><br>2.Proportion of patients having a confirmed Best response or Partial Response Or Complete response.(10 days duration). <br/ ><br>3.To assess the quality of life among the study participants using pre and post Study questionnaire (SF 12) <br/ ><br>Timepoint: Baseline and End of Study (10 days)