To test the effect of Zinobliss gel for treating Oral Ulcers

A Phase 3 Prospective Randomized Open label Multi centric Parallel Design study to evaluate the Efficacy and Safety of ZINOBLISS (Zinc Carnosine 2% and lignocaine 2%) for the Management of Oral Mucositis and stomatitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049982

Enrollment

Registered

2023-02-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K123- Oral mucositis (ulcerative)

Interventions

Intervention1: Zinobliss (Zinc Carnosine 2% and lignocaine 2%): use topically thrice daily for 10 days or until healing Control Intervention1: Hexigel (Chlorhexidine) and Zytee: Use Topically thrice d

Eligibility

Inclusion criteria

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to understand and willingness to sign a written informed consent document with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion criteria

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.

Design outcomes

Primary

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

Measure

Time frame

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

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Secondary

Measure	Time frame
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). 3. To assess the quality of life among the study participants using pre and post Study questionnaire (SF 12) Timepoint: Baseline and End of Study (10 days)	—

Measure

Time frame

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). 3. To assess the quality of life among the study participants using pre and post Study questionnaire (SF 12) Timepoint: Baseline and End of Study (10 days)

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Countries

India

Contacts

Public ContactDrGayathri

MGMC&RI

ravanthika2007@gmail.com9442503635

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026