| CTRI Number |
CTRI/2023/02/049982 [Registered on: 22/02/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To test the effect of Zinobliss gel for treating Oral Ulcers |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZINO/11/22 Version:1.0 , 05-11-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vidhyalakshmi |
| Designation |
Professor |
| Affiliation |
MGMC&RI |
| Address |
Room no. 1, Department of Dentistry, Mahatma Gandhi medical College and Research Institute, Pondicherry
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9442503635 |
| Fax |
|
| Email |
ravanthika2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidhyalakshmi |
| Designation |
Professor |
| Affiliation |
MGMC&RI |
| Address |
Room no. 1, Department of Dentistry, Mahatma Gandhi medical College and Research Institute, Pondicherry
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9442503635 |
| Fax |
|
| Email |
ravanthika2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGayathri |
| Designation |
VP Operations |
| Affiliation |
Kai3 |
| Address |
Regus Office Centre Services (Chennai) Pvt Ltd.
Olympia Technology Park, Level - 2, Altius Block,
No -1, SIDCO Industrial Estate, Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
|
| Fax |
|
| Email |
Venkat_ani2007@yahoo.Co.in |
|
|
Source of Monetary or Material Support
|
| Puneet Laboratories Pvt. Ltd.
605, Raheja Plaza, B- Wing, LBS Marg, Ghatkopar West,
Mumbai, Maharashtra 400086 |
|
|
Primary Sponsor
|
| Name |
Puneet Laboratories Pvt. Ltd. |
| Address |
E-209. Neptune Eastern Business District, Lal Bahadur Shastri Rd, Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vidyalakshmi |
Mahatma Gandhi Medical College and Research Institute |
Room no. 1, Department of Dentistry, MGMC&RI, Pillayarkuppam, Pondicherry
Pondicherry
PONDICHERRY |
7667273635
ravanthika2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K123||Oral mucositis (ulcerative), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hexigel (Chlorhexidine) and Zytee |
Use Topically thrice daily for 10 days or until healing |
| Intervention |
Zinobliss (Zinc Carnosine 2% and lignocaine 2%) |
use topically thrice daily for 10 days or until healing |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 ] |
Baseline and End of Study (10 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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)
|
Baseline and End of Study (10 days) |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/02/2023 |
| Date of Study Completion (India) |
01/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The subjects who fulfilled the
inclusion and exclusion criteria will be enrolled in the study.
45 Participants will be randomized
into 3 groups with 15 in each group.
Arm 1 - Participants with Oral Mucositis and stomatitis will
use topical administration of Zinobliss thrice daily for 10 days or until
healing.
Arm 2- Participants
with Oral Mucositis and stomatitis will use topical administration of Hexigel (Chlorhexidine) thrice daily for 10
days or until healing.
Arm 3- Participants with Oral
Mucositis and stomatitis will use topical administration of
Zytee (Choline
salicylate+ Lignocaine) thrice daily for 10 days or until healing. Evaluation of the subjects
will be done at baseline and the end of the study |