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CTRI Number  CTRI/2025/12/098415 [Registered on: 03/12/2025] Trial Registered Prospectively
Last Modified On: 02/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to find out whether Nimbamrutham herbal mouthwash can prevent and reduce mouth sores in head and neck cancer patients receiving chemo-radiotherapy 
Scientific Title of Study   Efficacy of ‘Nimbamrutham’ Herbal Mouthwash in Prevention and Management of Concurrent Chemo-Radiotherapy Induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled 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 Rejnish Kumar R 
Designation  Additional Professor  
Affiliation  Regional cancer centre Thiruvananthapuram 
Address  Department of Radiation Oncology Regional cancer centre Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9447072333  
Fax    
Email  rejnish@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Indulekha V C 
Designation  Associate Professor 
Affiliation  Govt Ayurveda College Thiruvananthapuram 
Address  Department of Dravyagunavigyan Govt Ayurveda College Thiruvananthapuram Pin 695001

Thiruvananthapuram
KERALA
695001
India 
Phone  9446553068  
Fax    
Email  drindulekha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anchu T M 
Designation  MD Scholar 
Affiliation  Govt Ayurveda College Thiruvananthapuram 
Address  Department of Dravyagunavigyan Govt Ayurveda College Thiruvananthapuram Pin 695001

Thiruvananthapuram
KERALA
695001
India 
Phone  9020880990  
Fax    
Email  anchutm@gmail.com  
 
Source of Monetary or Material Support  
Dept of Dravyagunavigyan Govt Ayurveda College Thiruvananthapuram kerala India pin 695001 
Dept of Radiation Oncology Regional cancer centre Thiruvananthapuram kerala India pin 695011 
 
Primary Sponsor  
Name  Dr Anchu T M 
Address  DR Anchu T M MD Scholer Dept of Dravyagunavigyan Govt Ayurveda College Thiruvananthapuram pin 695001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rejnish Kumar R  Regional Cancer Centre Thiruvananthapuram  OP Number 3 Radiation and Oncology Regional Cancer Centre Medical College Campus Thiruvananthapuram Kerala India Pin 695011
Thiruvananthapuram
KERALA 		 9447072333

rejnish@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HUMEN ETHICS COMMITTEE REGIONAL CANCER CENTRE THIRUVANANTHAPURAM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L599||Disorder of the skin and subcutaneous tissue related to radiation, unspecified. Ayurveda Condition: MUKHAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Sodium bicarbonate-salt solution gargleSodium bicarbonate–salt solution mouth rinse (½ tsp sodium bicarbonate add ½ tsp salt in 250 ml warm water, freshly prepared). Dose 50 ml rinse gargle each time. Frequency four times daily. Route Topical oral rinse.
2Intervention ArmDrugClassical(1) Medicine Name: Nimbamritha Mouthwashes, Reference: ASHTANGA SANGRAHA UTTARASTANA 26 /60, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: qid, Bhaishajya Kal: Antarabhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: -External use as mouth wash
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All head and neck cancer patients receiving radical radiotherapy /chemoradiotherapy to the oral cavity and oropharynx.
Patients between the age group of 18 to 70 years.
Patients willing to participate, after signing informed consent.
 
 
ExclusionCriteria 
Details  Palliative radiotherapy.
Patients receiving radiation to sites other than oral mucosa.
Patients with associated complications such as chronic renal failure, hepatic disorders, and mental confusion

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Radiation Therapy Oncology Group (RTOG) scoring system  Week 1
Week 2
Week 3
Week 4
Week 5
Week 6  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
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 3 
Date of First Enrollment (India)   15/12/2025 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  On Personal contact via google drive

  6. For how long will this data be available start date provided 20-12-2025 and end date provided 20-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Head and neck cancer patients who receive concurrent chemo radiotherapy often develop oral mucositis. This is a painful inflammation and ulceration of the mouth that affects eating, swallowing, sleep, nutrition, and overall quality of life. Severe mucositis may lead to treatment breaks, infections, increased hospital stay and higher treatment costs. At present, commonly used management methods such as soda saline mouthwash and symptomatic medicines provide only limited relief.

Ayurveda describes a similar condition called mukhapaka and recommends local treatments such as herbal gargling. Nimbamrutham is a traditional Ayurvedic preparation made from neem and guduchi. These herbs are known for their antimicrobial, anti inflammatory and healing properties. This study aims to evaluate the effect of Nimbamrutham mouthwash in patients undergoing chemo radiotherapy.

In this randomized study, patients will be divided into two groups. One group will use the routine soda saline mouthwash and the other group will use Nimbamrutham mouthwash. Both groups will perform gargling four to six times daily from the first day of radiation. The severity of oral mucositis will be assessed every week using the RTOG grading system. The study aims to find out whether Nimbamrutham can reduce the severity of mucositis and improve patient comfort during treatment.

 
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