To test the effect of Zinobliss gel for treating Oral Ulcers

Phase 3

Completed

Brief Summary: The subjects who fulfilled theinclusion and exclusion criteria will be enrolled in the study.

45 Participants will be randomizedinto 3 groups with 15 in each group.

Arm 1 - Participants with Oral Mucositis and stomatitis willuse topical administration of Zinobliss thrice daily for 10 days or untilhealing.

Arm 2- Participantswith Oral Mucositis and stomatitis will use topical administration of Hexigel (Chlorhexidine) thrice daily for 10days or until healing.

Arm 3- Participants with OralMucositis and stomatitis will use topical administration of Zytee (Cholinesalicylate+ Lignocaine) thrice daily for 10 days or until healing.

Evaluation of the subjectswill be done at baseline and the end of the study

Recruitment & Eligibility

Inclusion Criteria

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.
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to understand and willingness to sign a written informed consent document with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria

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.

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]	Baseline and End of Study (10 days)
2.Healing of Mucositis/stomatitis (assessed by investigator- with photographs and measurement of the lesion) [time frame: 10 days]	Baseline and End of Study (10 days)
3.Incidence & duration of treatment-emergent xerostomia. [time frame: 10 days]	Baseline and End of Study (10 days)
4.Incidence & duration of Taste disturbance, Oral irritation / Burning sensation and teeth staining. [time frame: 10 days]	Baseline and End of Study (10 days)
5.Use of rescue medication (analgesics) for pain. [time frame: 10 days]	Baseline and End of Study (10 days)
6.Incidence of need for a modified diet (soft, liquid, TPN) [ Time Frame: 10 days ]	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)	2.Proportion of patients having a confirmed Best response or Partial Response Or Complete response.(10 days duration).

Locations (1): Mahatma Gandhi Medical College and Research Institute
🇮🇳
Pondicherry, PONDICHERRY, India
Mahatma Gandhi Medical College and Research Institute
🇮🇳Pondicherry, PONDICHERRY, India
Dr Vidyalakshmi
Principal investigator
7667273635
ravanthika2007@gmail.com