| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K135||Oral submucous fibrosis. Ayurveda Condition: SARVASARA MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator 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. | | 2 | Intervention Arm | Drug | Classical | | (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. | | 3 | Intervention Arm | Drug | Other 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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