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CTRI Number  CTRI/2025/02/079909 [Registered on: 03/02/2025] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy
Radiation Therapy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Management of cancer treatment induced Oral mucositis with add on homoeopathy to standard care versus the standard care in patients with head and neck cancer 
Scientific Title of Study   Management of Chemotherapy and radiotherapy induced Oral mucositis with add on homoeopathy to standard care versus the standard care in patients with head and neck cancer - A Randomized Controlled 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  Chetna Deep Lamba 
Designation  Research Officer Homoeopathy Scientist3 
Affiliation  Central Council Research for Homoeopathy 
Address  Room 139 Homoeopathic Treatment Centre Safdarjung Hospital New Delhi

South
DELHI
110029
India 
Phone  9899396304  
Fax    
Email  drchetnalamba@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sunita Gupta 
Designation  Senior Professor and Head, Oral Medicine and Radiology  
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  Maulana Azad Institute of Dental Sciences, MAMC Delhi University , New Delhi

South
DELHI
110002
India 
Phone  9654700955  
Fax    
Email  drsunitagupta@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sunita Gupta 
Designation  Senior Professor and Head, Oral Medicine and Radiology  
Affiliation  Maulana Azad Institute of Dental Sciences 
Address  Maulana Azad Institute of Dental Sciences, MAMC Delhi University , New Delhi

South
DELHI
110002
India 
Phone  9654700955  
Fax    
Email  drsunitagupta@yahoo.com  
 
Source of Monetary or Material Support  
Central Council for Research in Homoeopathy 61-65 Institutional Area Janakpuri New Delhi - 110058 India 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy 
Address  61-65 Institutional Area Janak Puri New Delhi 110058 
Type of Sponsor  Research institution 
 
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 Sunita Gupta  Maulana Azad Institute of Dental Sciences  Room number 2 Ground Floor Department of Oral Medicine and Radiology Maulana Azad Institute of Dental Sciences New Delhi 110002
Central
DELHI 
96547 00955

drsunitagupta@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K123||Oral mucositis (ulcerative), (2) ICD-10 Condition: K123||Oral mucositis (ulcerative),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Add on homoeopathic treatment  Homoeopathic medicines in centesimal decimal LM potencies shall be given as an add to standard allopathic medicines Mother tinctures will be used as a local oral wash where indicated. Selection of the medicine will be done after case taking on the basis of presenting totality of symptoms. The prescription shall be justified from Materia Medica or Repertory. Potency and dosage shall be as indicated. For centesimal dilutions (6c, 30c, 200c or 1M potency) The medicine will be repeated depending on the potency and complaints of the patient in accordance with the principles of Homoeopathy. Each dose of indicated medicine shall consist of four globules (size no. 30) mixed in 100 ml of water. It can be administered in fractional or divided doses. Identical placebo in water doses shall be given where required. For LM potency The treatment of each patient should begin with 0/1 potency to be followed by next higher potency, serially, as per need of the case. Duration of intervention is 8 weeks.  
Comparator Agent  Placebo  Add on identical placebo shall be given to the control arm with standard allopathic medicines 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects 18 years and above with any stage of head and neck cancer undergoing chemotherapy and or radiotherapy

Subjects with Oral mucositis as per RTOG Scoring Criteria after initiation of chemotherapy and/ or radiotherapy 
 
ExclusionCriteria 
Details  Inability to comply with the study protocol

Subject under any other treatment such as Ayurveda or Unani for Oral Mucositis

Subjects not willing to participate after complete information
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the reduction resolution (Grade 0 whenever it is achieved during study period) or increase in grades/scores of Oral Mucositis Assessment Scale Score in add on homoeopathy and standard care   At baseline twice weekly for the initial 08 weeks and once weekly subsequent 08 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
• To compare the changes of Patient Reported Oral Mucositis symptom (PROMS) Questionnaire in add on homoeopathy and standard care   At baseline twice weekly for the initial 08 weeks and once weekly subsequent 08 weeks 
• To compare the compliance to prescribed Chemotherapy and/or Radiotherapy in add on homoeopathy and standard care group  Baseline and 16 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   12/03/2025 
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="2"
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  

Oral mucositis is a common, debilitating complication of cancer chemotherapy and radiotherapy, occurring in about 40 percent of patients. Patients treated with radiation therapy for head and neck cancer typically receive an approximately 200 centigray daily dose of radiation, five days per week, for 5 to 7 continuous weeks. Almost all such patients will develop oral mucositis. 

The development of Grade III mucositis warrants stoppage of radiotherapy as further injury to the mucosa causes permanent injury to the mucosa. Resolutions occurs 3 to 6weeks after completion of radiotherapy. In cases of severe oral morbidity, the patient may no longer be able to continue cancer therapy; treatment is then usually discontinued. These disruptions in dosing due to oral complications can directly affect patient survivorship.

A wide variety of validated scales have been used to record the extent and severity of oral mucositis in clinical practice and research including the Oral Mucositis Assessment Scale (OMAS) and Patient Reported Oral Mucositis Symptom (PROMS) will be used for the assessment and follow up of the cases. The Radiation Therapy Oncology Group (RTOG) has developed the Acute Radiation Morbidity Scoring Criteria for the evaluation of Radiotherapy treatments. The RTOG grading is reliant on a ability of clinician to judge the anatomical changes associated with oral mucositis (size and characteristics of ulceration) and shall be used for assessing the inclusion of cases in this study.

Research shows many agents have been tested for prevention and treatment of mucositis: oral glutamine supplementation, sucralfate, steroids, immunoglobulin, amifostine, antibiotic lozenges, chlorhexidine rinses, vitamin E, salt and soda mouthwash, but none of them showed optimal symptom relief and reduction in the intensity or duration of the lesions. Thus, there is a need for alternative therapeutic approaches. 

 

Thus, fundamental and clinical research studies in Homoeopathy suggest that homoeopathy treatment can influence the prognosis and quality of life in cancer patients and also help in managing the repercussions of conventional cancer treatment. However, systematic studies having statistical rigor are lacking. As individualised homoeopathy has not been evaluated for treatment induced mucositis, this exploratory study is proposed.


 
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