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CTRI Number  CTRI/2025/08/092376 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Probiotic
Other (Specify) [HONEY AND TURMERIC MIXTURE]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparisons Of Various Treatment Modalities For ORAL ULCERS 
Scientific Title of Study   EVALUATION OF VARIOUS TREATMENT MODALITIES FOR RECURRENT APHTHOUS ULCER A RANDOMIZED CLINICAL CONTROLLED STUDY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MRUGA JOSHI 
Designation  POST GRADUATE STUDENT 
Affiliation  GOVERNMENT DENTAL COLLEGE AND HOSPITAL AHEMDABAD 
Address  DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY GROUND FLOOR GOVERMENT DENTAL COLLEGE AND HOSPITAL AHEMDABAD

Ahmadabad
GUJARAT
380016
India 
Phone  9979545476  
Fax    
Email  mrugajoshi101@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SHIPLA PARIKH 
Designation  PROFFESOR 
Affiliation  GOVERNMENT DENTAL COLLEGE AND HOSPITAL AHEMDABAD 
Address  DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY GROUND FLOOR GOVERMENT DENTAL COLLEGE AND HOSPITAL AHEMDABAD

Ahmadabad
GUJARAT
380016
India 
Phone  9426247755  
Fax    
Email  drshilpaparikh@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SHIPLA PARIKH 
Designation  PROFFESOR 
Affiliation  GOVERNMENT DENTAL COLLEGE AND HOSPITAL AHEMDABAD 
Address  DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY GROUND FLOOR GOVERMENT DENTAL COLLEGE AND HOSPITAL AHEMDABAD

Ahmadabad
GUJARAT
380016
India 
Phone  9426247755  
Fax    
Email  drshilpaparikh@hotmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY GOVERNMENT DENTAL COOLEGE AND HOSPITAL AHEMDABAD 380016 GUJARAT INDIA 
 
Primary Sponsor  
Name  MRUGA JOSHI 
Address  DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY GOVERNMENT DENTAL COLLEGE AND HOSPITAL ASARWA AHEMDABAD 380016 GUJARAT INDIA 
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 Shilpa Parikh  GOVERNMENT DENTAL COLLEGE AND HOSPITAL AHMEDABAD  DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY GROUND FLOOR
Ahmadabad
GUJARAT 
9426247755

drshilpaparikh@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT DENTAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K120||Recurrent oral aphthae,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.1% triamcinolone acetonide TOPICAL APPLIOCATION 3 TIMES A DAY  Topical application of 0.1 PERCENTAGE triamcinolone acetonide Participants were advised to apply thrice daily over ANDaround 1 cm of each ulcer by cotton applicator tip AND advised not to eat OR drink for next 30 mins  
Intervention  A monotherapy of microbiome pre probiotic orally Bacillus mesentericus 15 Million Cells Clostridium butyricum 15 Million Cells Fructooligosaccharides FOS 100 MG Lactobacillus acidophilus 15 Million Cells Streptococcus thermophilus 15 Million Cells ORALLY  A monotherapy of microbiome pre probiotic orally Participants will be advised to take capsule thrice daily with food for a week  
Intervention  Topical application of mixture of turmeric powder and honey APPLY FOR 3 TIMES A DAY  Topical application of mixture of turmeric powder and honey Participants will be advised to freshly prepare at the time of every application mixture of ¼ tea spoon of turmeric powder AND ¼ tea spoon of honey apply thrice daily over and around 1 cm of each ulcer with cotton applicator tip and advised not to eat or drink or spit for next 30 mins Also instructed to use clean utensils while preparing mixture and apply mixture after gargling  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Subjects of both gender attending daily routine OPD
Subjects suffering from recurrent major & minor aphthous ulcer.
Subjects willing to participate & giving informed consent.
Patients not taking any other medications.
 
 
ExclusionCriteria 
Details  Recurrent aphthous ulcer in an inaccessible area.
Pregnant or lactating women
Patient already undergoing treatment for ulcer.
Ulcer associated with other oro- mucosal lesion / ulcer.
Patients with systemic diseases like Bechet syndrome, Sweet syndrome, periodic fever adenitis pharyngitis aphthous ulcer (PFAPA), Reiter syndrome, Crohn’s disease, Gluten sensitive enteropathy etc.
Subjects hypersensitive to agents used in this trial.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
REDUCTION OF APHTHOUS ULCER SIZE MEASURED BY WILLIAM PROBE AND RELIEF IN SYMPTOMS   ON FIRST DAY AFTER 3 DAYS AFTER 7 DAYS  
 
Secondary Outcome  
Outcome  TimePoints 
REDUCTION OF APHTHOUS ULCER SIZE MEASURED BY WILLIAM PROBE AND RELIEF IN SYMPTOMS   AFTER 3 DAYS AND 7 DAYS OF INTERVENTION 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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 4 
Date of First Enrollment (India)   20/08/2025 
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 - NO
Brief Summary  

 Recurrent aphthous stomatitis are common painful oral ulcers  categorized as minor major herpetiform. Etiology involves stress immunologic hormonal hereditary environmental factors Treatment includes Honey-Turmeric mix cap. Pre-pro biotic Topical Triamcinolone

 

Study Aims & Objectives

 To compare efficacy of Oral probiotics Topical steroids Topical application of turmeric powder with honey in management of recurrent aphthous ulcer

The objectives are

    To assess the efficacy of 3 treatment modalities in pain, burning sensation and reduction in size

  To evaluate the most effective treatment plan for healing of  recurrent aphthous ulcer

 

Methodology

·         Study Location Department of Oral Medicine and Radiology Government Dental College and Hospital Ahmedabad

·         Probable estimated time to complete the study  2 years

·         Sample size with calculation formula Statistician Certificate is mandatory  Total 138  patients 46 in each group analysis done using A priori 

·         Inclusion and Exclusion Criteria

INCLUSION CRITERIA

    Subjects of both gender attending daily routine OPD

   Subjects suffering from recurrent major & minor aphthous ulcer

    Subjects willing to participate & giving informed consent

 Patients not taking any other medications

EXCLUSION CRITERIA

·         Recurrent aphthous ulcer in an inaccessible area

·         Pregnant or lactating women

·         Patient already undergoing treatment for ulcer

·         Ulcer associated with other oro mucosal lesion or ulcer

·         Patients with systemic diseases like Bechet syndrome Sweet syndrome periodic fever adenitis pharyngitis aphthous ulcer PFAPA Reiter syndrome Crohn’s disease Gluten sensitive enteropathy etc

·         Subjects hypersensitive to agents used in this trial

 

 

·         Armamentarium and Methodology

·         Armamentarium

Diagnostic instruments

Williams Graduated Probe

Informed consent the study is explained followed by which an informed consent is taken from the patient

 All patients were given dietary instructions to avoid spicy food & encouraging a bland diet

The patient would be assessed on various parameters like

1.      Pain  or Burning sensation

2.      Lesion size

3.      Number of lesion

4.      Difficulty in chewing or speaking

1.)    Pain The intensity of pain was determined by visual analogue scale VAS

          From 1to 10

0         Absent

1to 3 Mild

4to7 Moderate

8to10 Severe

1        Burning sensation: Burning sensation was recorded using VAS as follows

                                              0to3Mild Burning sensation

                                              4to7Moderate Burning sensation

                                              8to10 severe Burning sensation

     Size of ulcer The size of ulcer was measured using Williams graduated probe

     Number of ulcer

   Difficulty in chewing or speaking yes or  no

 

Group 1 A monotherapy of microbiome pre probiotic orally

Participants were advised to take capsule thrice daily with food for a week.

 

Group 2 Topical application of mixture of turmeric powder and honey

Participants were advised to freshly prepare (at the time of every application) mixture of ¼ tea spoon of turmeric powder & ¼ tea spoon of honey, apply thrice daily over and around 1 cm of each ulcer with cotton applicator tip & advised not to eat or drink or spit for next 30 mins.

Also instructed to use clean utensils while preparing mixture & apply mixture after gargling.

 

Group 3 Topical application of 0.1% triamcinolone acetonide

      Participants were advised to apply thrice daily over and around 1 cm of each ulcer by cotton applicator tip & advised not to eat or drink for next 30 mins

 

 

 

·         Observational Parameters VAS score for pain burning sensation and measuring size of ulcer on 0 4 & 7 day

·      

         Concluding Remarks or  expected outcomes

   The results will compare between the efficacy and  rapidity to response of all the three different treatment modalities resulting in reduction in size of ulcer pain and in burning sensation with reduction in frequency of recurrence.

 
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