| CTRI Number |
CTRI/2025/04/084509 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Desmostachya Bipinnata Platinum Patch for Oral Ulcers in Cancer Therapy |
|
Scientific Title of Study
|
Assessment Of Efficacy Of Anti-tumorigenic Potential Of Desmostachya bipinnata(Db) Conjugated Silver and Platinum Nanoparticles In Therapeutic Management Of Oral Squamous Cell Carcinoma
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nitya Krishnasamy |
| Designation |
Research Scientist |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospital
No 162
Poonamalle High Road Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
09962623510 |
| Fax |
|
| Email |
drknitya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramya Ramadoss |
| Designation |
Professor and Head |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospital
No 162
Poonamalle High Road Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
8825876700 |
| Fax |
|
| Email |
ramyar.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitya Krishnasamy |
| Designation |
Research Scientist |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospital
No 162
Poonamalle High Road Velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
09962623510 |
| Fax |
|
| Email |
drknitya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research,Department of Health Research
2nd Floor, IRCS Building,
1, Red Cross Road,
New Delhi - 110001. |
|
|
Primary Sponsor
|
| Name |
Department of Health Research |
| Address |
Department of Health Research
2nd Floor, IRCS Building,
1, Red Cross Road,
New Delhi - 110001. |
| Type of Sponsor |
Government funding agency |
|
|
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 Nitya Krishnasamy |
SAVEETHA DENTAL COLLEGE & HOPSITALS |
Dr.Nitya K, Department of Oral Biology , Clinic - 29, 5th Floor,PH Road, Velappanchavadi, Chennai -600077
Chennai
TAMIL NADU |
09962623510
drknitya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mucoplat |
Desmostachya bipinnata-derived platinum nanocomplex is integrated into a mucoadhesive patch to provide targeted therapy for chemotherapy-induced oral mucositis. This novel formulation combines the anti-inflammatory and wound-healing properties of Desmostachya bipinnata with the enhanced bioavailability of platinum nanoparticles. The patch adheres to the oral mucosa, ensuring prolonged drug retention and localized therapeutic action. It aims to reduce pain, inflammation, and ulceration while promoting faster tissue regeneration. This approach offers a promising plant-based alternative for managing oral mucositis in cancer patients(Time period of 6 months) |
| Comparator Agent |
Placebo Control |
Placebo Control |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 30 years and above, diagnosed with oral squamous cell carcinoma (OSCC) and operated for the same.
Undergoing chemotherapy post-surgery and at risk of developing oral mucositis.
Willing to participate and provide informed consent.
No known allergies to the Db platinum mucoadhesive patch components. |
|
| ExclusionCriteria |
| Details |
Patients with severe (Grade 4) oral mucositis at baseline.
History of severe allergic reactions to herbal or nanoparticle-based formulations.
Presence of active oral infections (bacterial, viral, or fungal).
Pregnant or lactating women or those with severe systemic illnesses.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Oral Mucositis Severity
Measured using the World Health Organization (WHO) Oral Mucositis Grading Scale or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
Assessed by the reduction in ulcer size, severity of pain, and ability to eat/drink |
The follow-up schedule includes assessments at Day 0 (baseline), Day 3 (early pain reduction and safety check), Day 7 (mucositis improvement and compliance check), Day 14 (final mucositis grading and microbial analysis), Day 21 (extended healing evaluation if needed), and Day 30 (long-term QoL assessment). These timepoints provide a comprehensive evaluation of the therapeutic efficacy, safety, and patient adherence to the Db platinum mucoadhesive patch |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain Reduction
Assessed using the Visual Analog Scale (VAS) (0 = no pain, 10 = worst pain).
Healing Rate of Oral Ulcers
Measured by lesion size reduction & complete resolution percentage.
Patient-Reported Quality of Life
Evaluated using Oral Mucositis Quality of Life (OMQoL) scale or other validated tools.
Time to Mucositis Resolution
Days taken for complete healing of oral lesions.
|
Time Points for Outcome Assessment
Baseline (Day 0): Before starting the intervention (Initial assessment).
Week 1: Early response to treatment.
Week 2: Mid-treatment evaluation.
Week 4: Primary outcome assessment to determine efficacy.
Week 6: Follow-up to assess sustained effects.
Week 8: Final evaluation for long-term healing & relapse prevention.. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We are conducting this study to develop an effective, plant-based nanomedicine for managing chemotherapy-induced oral mucositis, a painful and debilitating condition that significantly impacts cancer patients’ quality of life, nutrition, and treatment adherence. Current treatments provide limited relief and often have side effects, necessitating a safer, more effective alternative. The Db platinum mucoadhesive patch integrates Desmostachya bipinnata-derived phytochemicals with platinum nanoparticles, offering anti-inflammatory, wound-healing, and antimicrobial properties. This study aims to assess its efficacy in reducing mucositis severity, pain, and microbial load, while improving oral healing and patient comfort, ultimately enhancing clinical outcomes in cancer care. |