| CTRI Number |
CTRI/2026/02/102971 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Mucoheal Rinse and Chocolate in Preventing and Reducing Mouth Ulcers During Exposure to Chemo-Radiation in Cancer Patients |
|
Scientific Title of Study
|
Evaluation of Mucoheal Rinse and Mucoheal Chocolate in the Management of Chemo-Radiation Induced Mucocitis: An Exploratory Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swapnali bandu naik |
| Designation |
MD SCHOLAR DRAVYAGUNA |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
Depatment of Dravyaguna Dr.D.Y.Patil College Road, Sant
Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9702275632 |
| Fax |
|
| Email |
swapnali.b.naik11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swagata D tavhare |
| Designation |
Associate professor |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
Depatment of Dravyaguna Dr.D.Y.Patil College Road, Sant
Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7984956017 |
| Fax |
|
| Email |
drswagata32@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swapnali bandu naik |
| Designation |
MD SCHOLAR DRAVYAGUNA |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
Depatment of Dravyaguna Dr.D.Y.Patil College Road, Sant
Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9702275632 |
| Fax |
|
| Email |
swapnali.b.naik11@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr.swapnali bandu naik |
| Address |
Department of Dravyaguna Dr. D. Y. Patil College of Ayurved and Research Centre, Sant
Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 |
| Type of Sponsor |
Other [Self] |
|
|
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 Swapnali Bandu Naik |
Dr. D. Y. Patil College of Ayurved and Research Centre |
Department of Dravyaguna Dr. D. Y. Patil College of Ayurved and Research centre, pimpri, pune 411018
Pune
MAHARASHTRA |
9702275632
swapnali.b.naik11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K137||Other and unspecified lesions of oral mucosa. Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Mucoheal rinse, Reference: NA, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Mucoheal chocolate, Reference: NA, Route: Oral, Dosage Form: Lozenges, Dose: 9(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Known case of any type of cancer receiving chemotherapy or radiation therapy irrespective of duration, aged 18 to 75 years, of any gender, and presenting with oral mucositis, assessed using standardized and validated grading systems, including
World Health Organization Oral Toxicity Scale
RTOG/EORTC Oral Toxicity Scale
Oral Mucositis Assessment Scale
NCI–CTCAE National Cancer Institute – Common Terminology Criteria for Adverse Events Scale |
|
| ExclusionCriteria |
| Details |
Patients with pre-existing oral lesions or infections example oral candidiasis, herpes simplex, leukoplakia prior to initiation of chemotherapy or radiotherapy.
Patients with active systemic infections or febrile illness at the time of enrollment.
Patients with autoimmune or inflammatory oral conditions example oral lichen planus, pemphigus vulgaris.
Patients not willing to continue ongoing topical or systemic medications for oral mucosal conditions during the trial period. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical improvement in chemo-radiation induced oral mucositis following intervention with Muco-heal chocolate and Muco-heal rinse , measured through change in mucositis grade from baseline to end of treatment. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain reduction associated with oral mucositis |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/05/2026 |
| 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 Yet Recruiting |
| 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
|
This prospective, single-arm interventional study evaluates the efficacy and safety of Mucoheal chocolate and Mucoheal rinse in the management of chemo-radiation induced oral mucositis in cancer patients. A total of 12 patients will receive Mucoheal chocolate twice daily and Mucoheal oral rinse three times daily for 4 weeks, with follow-up assessments on the 7th, 14th, 21st, and 28th day.Outcomes will be assessed using standardized mucositis grading scales including WHO Oral Toxicity Scale, NCI-CTCAE , RTOG/EORTC scale, OMAS, and Modified Oral Mucositis Index , along with evaluation of pain, healing time, treatment compliance, tolerability, and patient-reported outcomes. |