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CTRI Number  CTRI/2024/10/075470 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 16/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Aged Garlic extract on minor RecurrentAphthous Stomatitis 
Scientific Title of Study   Comparative Evaluation of Aged Garlic extract and Triamcinolone Acetonide in minor Recurrent Aphthous Stomatitis. 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  Rutuja Kadam 
Designation  PG Student 
Affiliation  Government Dental College And Hospital Nagpur 
Address  Room No. 22, Department of Oral Medicine and Radiology, Government Dental College and Hospital, Nagpur, Maharashtra 440003, India.

Nagpur
MAHARASHTRA
440003
India 
Phone  9004733059  
Fax    
Email  dr.rutujakdam23@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR.ASHITA KALASKAR 
Designation  Professor 
Affiliation  Government Dental College And Hospital Nagpur 
Address  Room No. 22, Department of Oral Medicine and Radiology, Government Dental College and Hospital, Nagpur, Maharashtra 440003, India.

Nagpur
MAHARASHTRA
440003
India 
Phone  8550928585  
Fax    
Email  kalaskarashita@gmail.com  
 
Details of Contact Person
Public Query  
Name  RUTUJA KADAM 
Designation  PG STUDENT 
Affiliation  Government Dental College And Hospital Nagpur 
Address  Room No. 22, Department of Oral Medicine and Radiology, Government Dental College and Hospital, Nagpur, Maharashtra 440003, India.

Nagpur
MAHARASHTRA
440003
India 
Phone  9004733059  
Fax    
Email  dr.rutujakdam23@gmail.com  
 
Source of Monetary or Material Support  
Govt Dental College And Hospital, Nagpur Maharashtra 440003 India  
 
Primary Sponsor  
Name  DrRutuja Kadam 
Address  dept. of Oral medicine, radiology and diagnosis Government Dental College & Hospital Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur MAHARASHTRA 440003 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 Rutuja Kadam  Government Dental College and Hospital Nagpur  Room No 22, Department Of Oral Medicine And Radiology, Govt Dental College And Hospital, Nagpur Maharashtra 440003 India
Nagpur
MAHARASHTRA 		 9004733059

dr.rutujakadam23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Government Dental College Nagpur  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 
Intervention  Aged Garlic Extract   GROUP A Four capsule each containing Aged garlic extract of 600mg. Take two capsules with a meal two times a day. (BD) (Total Dose-2,400mg,per day) For 2 weeks.  
Intervention  combination therapy of Aged garlic extract capsule And triamcinolone acetonide 0.1 % buccal paste.   GROUP C Take two capsules with a meal two times a day. (BD) (Total Dose-2,400mg,per day) For 2 weeks. Triamcinolone acetonide 0.1 % buccal paste Apply three times a day on each ulcer after meals and not to consume food or water for half an hour after application For 2 weeks. 
Comparator Agent  Triamcinolone acetonide 0.1 % buccal paste  GROUP B Triamcinolone acetonide 0.1 % buccal paste Apply three times a day on each ulcer after meals and not to consume food or water for half an hour after application For 2 weeks.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with minor recurrent aphthous stomatitis, Presenting with single or multiple minor aphthous ulcers of more than 48 hours duration,
Ulcers must be in locations easily accessible for evaluation and treatment, such as the buccal mucosa, labial mucosa, floor of
the mouth, or tongue.
Diagnosed with RAS according to the original
criteria of Lehner (1968). 
 
ExclusionCriteria 
Details  History of allergies to garlic and triamcinolone acetonide,
Patients with recurrent aphthous ulcer major and recurrent herpetiform ulcer,
Patient already undergoing treatment for recurrent aphthous Stomatitis,
Pregnant and lactating females,
Patients on medication for any reason (oral problems, systemic Problems),
Patients with any systemic problem or syndrome,
Ulcers as a manifestation of systemic diseases. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
USS ulcerative severity score, (OHIS) Oral
health impact score 		 Patient will be recalled at the end of 4 th day, 7 th day,14 th day
• Post treatment follow up will be done on
monthly basis for three months (30 th day, 60 th day, 90 th day)
• Evaluation of the following parameters
will be done on each visit
1.Ulcer Severity Score(USS)
2.Oral health impact score(OHIS)
3.Adverse effects if any
- If Recurrence occurs, standard treatment (Triamcinolone Acetonide
0.1% buccal paste) will be provided. 
 
Secondary Outcome  
Outcome  TimePoints 
Side effects of intervention, if any  Patient will be recalled at the end of 4th day, 7th
day,14th day.
Post treatment follow up will be done on monthly
basis for three months (30th day, 60th day, 90th
day).
Evaluation of the following parameters will be
done on each visit
1.Ulcer Severity Score(USS)
2.Oral health impact score(OHIS)
3.Adverse effects if any
- If Recurrence occurs, standard treatment
(Triamcinolone Acetonide 0.1% buccal paste)
will be provided 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   30/10/2024 
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="6"
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   This study is randomized, parallel arm, open label clinical trial study considering the benefits of anti-inflammatory, anti-bacterial and immune modulatory properties of aged garlic extract, Aged garlic extract (AGE) capsules could be tried to evaluate its effect in Recurrent Aphthous Stomatitis(RAS). Also comparing it with first line therapy that is topical steroid would further help in exploring its effectiveness. Therefore this study is planned to evaluate the effectiveness of Aged garlic extract capsules in Recurrent Apthous stoamtatitis as compared to topical triamcenolone acetonide buccal paste (considered as the first line therapy in RAS) alone and dual therapy of AGE capsules and triamcenolone acetonide buccal paste. 
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