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CTRI Number  CTRI/2025/08/092406 [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   Dentistry
Other (Specify) [Emblica officinalis (Amla) in comparison with Combination of antioxidants and steroids ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Amla and Standard treatment along with mouth opening exercise in the treatment of Oral Submucous Fibrosis 
Scientific Title of Study   Comparative Efficacy of Emblica officinalis (Amla) and combination of (Antioxidants and Topical Steroids) along with Physiotherapy in the Management of Oral Submucous Fibrosis: A Clinical 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  Dr Pallavi Harshad Joshi  
Designation  Post Graduate Student 
Affiliation  Bharati Vidyapeeth Deemed to be University Dental College And Hospital, Pune. 
Address  Bharati Vidyapeeth Deemed to be University Dental College And Hospital, Pune Dhanakawadi- Katraj. Department of Oral Medicine And Radiology. Room No.14

Pune
MAHARASHTRA
411043
India 
Phone  7558607614  
Fax    
Email  joshipallu24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manjula Hebbale 
Designation  Associate Professor of Department of Oral Medicine And Radiology. 
Affiliation  Bharati Vidyapeeth Deemed to be University Dental College And Hospital, Pune. 
Address  Bharati Vidyapeeth Deemed to be University Dental College And Hospital, Pune Dhanakawadi- Katraj. Department of Oral Medicine And Radiology. Room No.14

Pune
MAHARASHTRA
411043
India 
Phone  9890178089  
Fax    
Email  manjula.hebbale@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Pallavi Harshad Joshi  
Designation  Post Graduate Student 
Affiliation  Bharati Vidyapeeth Deemed to be University Dental College And Hospital, Pune. 
Address  Bharati Vidyapeeth Deemed to be University Dental College And Hospital, Pune Dhanakawadi- Katraj. Department of Oral Medicine And Radiology. Room No.14

Pune
MAHARASHTRA
411043
India 
Phone  7558607614  
Fax    
Email  joshipallu24@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth Deemed to be University Dental College And Hospital, Pune. 
 
Primary Sponsor  
Name  Dr Pallavi Joshi 
Address  Bharati Vidyapeeth Deemed to be University Dental College And Hospital, Pune 
Type of Sponsor  Other [Self-Funding (Not Sponsored)] 
 
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 Pallavi Harshad Joshi  Bharati Vidyapeeth Deemed to be University Dental College And Hospital, Pune.  Bharati Vidyapeeth Deemed to be University Dental College And Hospital, Pune Dhanakawadi- Katraj, Pune 411043 Department of Oral Medicine And Radiology. Room No.14
Pune
MAHARASHTRA 
7558607614

joshipallu24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee of Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Pune.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K135||Oral submucous fibrosis. Ayurveda Condition: SARVASARA MUKHAROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Capsule SM Fibro and Topical 0.1% triamcinolone acetonide oral base.Patient will be instructed to take 1 capsule (Capsule SM Fibro) daily for a period of 3 months. Instructions will be given to the patient regarding the application of Topical 0.1% triamcinolone acetonide oral base. The patient will be asked to wipe the buccal mucosa with the help of sterilize cotton then take pea size of Topical 0.1% triamcinolone acetonide paste on clean finger and apply over the buccal mucosa and massage for 2 minutes thrice daily for a period of 3 months.
2Intervention ArmDrugClassical(1) Medicine Name: Tablet Amla 500mg, Reference: Jiva Ayurveda, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Patient will be instructed to take 1 tablet (Tablet Amla 500mg by Jiva Ayurveda) daily for a period of 3 months.
3Intervention ArmDrugOther than Classical(1) Medicine Name: Topical 8% Amla Gel , Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Instructions will be given to the patient regarding the application of Topical 8% Amla Gel. The patient will be asked to wipe the buccal mucosa with the help of sterilize cotton then take pea size of Topical 8% Amla Gel on clean finger and apply over the buccal mucosa and massage for 2 minutes thrice daily for a period of 3 months.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Patients aged between 20-40 years of either gender, with clinically diagnosed Oral Submucous Fibrosis
2. Patients with mouth opening greater than 30mm (Group A and Group B) according to Lai DR 1995
3. Patients who have not taken any treatment earlier for Oral Submucous Fibrosis
4. Patients who are ready to quit the associated habits and willing to participate in the study with regular follow up visits 
 
ExclusionCriteria 
Details  1.Patients with any other associated disease such as Oral Lichen Planus and Oral leukoplakia
2. Patient with any systemic/chronic debilitating diseases and who are on long term medications
3. Pregnant and lactating mothers 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Burning sensation, Interincisal mouth opening and Cheek flexibility  Day 0 (baseline), Day 15, Day 30, Day 45, Day 60,
Day 75, Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/09/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   The aim of the study is to determine the efficacy of Emblica officinalis in management of Oral Submucous Fibrosis by comparing it with combination of (Antioxidants and Topical Corticosteroids) along with physiotherapy.
Patients visiting the OPD with chief complaint of burning sensation, restricted mouth opening and reduced cheek flexibility will be selected for the study.
A detailed case history of these patients will be recorded and patients which are clinically diagnosed with Oral Submucous Fibrosis will be included in the present study.
Detailed information of the study will be given to all the individuals.
Patients fulfilling the Inclusion and Exclusion criteria and ready to willingly participate in the study will be enrolled in the study.
A written informed consent would be obtained.
After obtaining the consent, patients will be assigned to the groups.
The study will consist of 40 patients
The study group will be divided into two groups where Group A - 20 patients will be the control group and Group B- 20 patients will be the experimental group.

Group A patients would be treated with antioxidants and topical steroid Capsule SM Fibro (OD for 3 months) and Topical 0.1% triamcinolone acetonide oral base (Kenacort TM 0.1% Abbott, India) (apply 3 times for 3 months) For each participant initial assessment (baseline) and periodic assessment will be recorded. In initial assessment (Day 0) detailed information will be obtained through personal interview and clinical examination, after obtaining informed consent and entering all the data in case proforma. Intervention will be started immediately from a Day 0 after noting down all the clinical parameters. Patient will be instructed to take 1 capsule (Capsule SM Fibro) daily for a period of 3 months. Instructions will be given to the patient regarding the application of Topical 0.1% triamcinolone acetonide oral base. The patient will be asked to wipe the buccal mucosa with the help of sterilize cotton then take pea size of Topical 0.1% triamcinolone acetonide paste on clean finger and apply over the buccal mucosa and massage for 2 minutes thrice daily for a period of 3 months. The patient will be advised not to eat or drink anything for half an hour and then will be asked to rinse their mouth with water. Patients will be advised physiotherapy exercise using ice-cream stick four times in a day for 3 months. Patients will be recalled twice in a month for 3 months i.e. Day 0 (baseline), Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 to assess for Burning sensation, Interincisal mouth opening and Cheek flexibility. Data gathered at each visit baseline as well as periodic visits will be entered in the case proforma. The photographic records for Interincisal mouth opening will be obtained at the baseline as well as the periodic visits.

Group B patients would be treated with Emblica officinalis (Amla) (systemic and 8% topical gel) Tablet Amla 500mg (Jiva Ayurveda) (OD for 3 months) and Topical 8% Amla Gel (apply 3 times for 3 months) For each participant initial assessment (baseline) and periodic assessment will be recorded. In initial assessment (Day 0) detailed information will be obtained through personal interview and clinical examination, after obtaining informed consent and entering all the data in case proforma. Intervention will be started immediately from a Day 0 after noting down all the clinical parameters. Patient will be instructed to take 1 tablet (Tablet Amla 500mg by Jiva Ayurveda) daily for a period of 3 months. Instructions will be given to the patient regarding the application of Topical 8% Amla Gel. The patient will be asked to wipe the buccal mucosa with the help of sterilize cotton then take pea size of Topical 8% Amla Gel on clean finger and apply over the buccal mucosa and massage for 2 minutes thrice daily for a period of 3 months. The patient will be advised not to eat or drink anything for half an hour and then will be asked to rinse their mouth with water. Patients will be advised physiotherapy exercise using ice-cream stick four times in a day for 3 months. Patients will be recalled twice in a month for 3 months i.e. Day 0 (baseline), Day 15, Day 30, Day 45, Day 60, Day 75, Day 90 to assess for Burning sensation, Interincisal mouth opening and Cheek flexibility. Data gathered at each visit baseline as well as periodic visits will be entered in the case proforma. The photographic records for Interincisal mouth opening will be obtained at the baseline as well as the periodic visits.
Both the groups will be advised physiotherapy exercise using ice-cream stick four times in a day for 3 months.

Clinical significance for this study includes, it can be used as a non invasive treatment modality with no side effects in the management of oral submucous fibrosis. Also self applicable topical therapy which tends to be preferred by the patients, thus reducing the number of hospital visits.


 
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