| CTRI Number |
CTRI/2026/01/100292 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare a new anti-oxidant medicine Astaxanthin with standard Anti-oxidant medicine (Capsule SM Fibro)in the treatment of Oral Submucous Fibrosis in adults. |
|
Scientific Title of Study
|
Prospective assessment of the efficacy of Astaxanthin-a novel carotenoid anti-oxidant drug as compared to standard anti-oxidant drug(Capsule SM Fibro-lycopene,beta carotene) in the management of Grade I,II and III Oral Submucous Fibrosis patients aged 18 to 60 years: A Double Blind Randomised 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 |
Dr Janice John |
| Designation |
Ph.D. Scholar at Nair Hospital Dental College |
| Affiliation |
Nair Hospital Dental College ,Mumbai. |
| Address |
Nair Hospital Dental College,
Dr. A. L Nair Road, Opp.Maratha Mandir, Mumbai.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7875987109 |
| Fax |
|
| Email |
drjanicejohn1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Janice John |
| Designation |
Assistant Professor |
| Affiliation |
ACPM Dental College, Dhule |
| Address |
Flat no.10, second floor,ACPM Dental College,Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
7875987109 |
| Fax |
|
| Email |
drjanicejohn1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Janice John |
| Designation |
Assistant Professor |
| Affiliation |
ACPM Dental College, Dhule |
| Address |
Flat no.10, second floor,ACPM Dental College,Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
7875987109 |
| Fax |
|
| Email |
drjanicejohn1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no.2, First Floor, Dept of Oral and Maxillofacial Surgery ,
JMFs Annasaheb Chudaman Patil Memorial Dental College,
Post Box No.145, Sakri Road, Dhule, Maharashtra
Pin Code: 424001.
India |
|
|
Primary Sponsor
|
| Name |
Dr Janice John |
| Address |
Flat no.10, Second floor,JMFs Annasaheb Chudaman Patil Memorial Dental College Staff Quarters, Sakri Road, Dhule,
MAHARASHTRA-
424001.
India |
| Type of Sponsor |
Other [Self 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 |
| DrJanice John |
JMFs ACPM Dental College, Dhule |
Room no.2, First floor, Dept of Oral and Maxillofacial Surgery.
Post box No.145,
Sakri Road.
Dhule
MAHARASHTRA |
7875987109
drjanicejohn1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee Nair Hospital Dental College and IEC ACPM Dental College, Dhule |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Astaxanthin 4 mg BD for 3 months in the study group. |
Patients selected will be treated with antioxidant Astaxanthin 4 mg BD for 3 months along with oral physiotherapy and habit cessation.
Various parameters will be evaluated at baseline and at regular intervals like trismus, improvement in tongue protrusion, cheek flexibility, etc.Follow -up of all pts will be continued for 6 months after completion of drug therapy. |
| Comparator Agent |
Standard antioxidant drug Capsule SM Fibro(lycopene, beta-carotene,selenium, zinc,etc) BD for 3 months in the control group. |
The patients selected will be treated with Capsule SM Fibro BD for 3 months along with oral physiotherapy and habit cessation in the control group.Various parameters will be evaluated at baseline and at regular intervals like trismus,improvement in tongue protrusion,cheek flexibility,etc.Follow -up of all patients will be continued till 6 months after completion of drug therapy |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged 18-60 years diagnosed with Grade I,II and III OSMF planned for medicinal management alone.
2)Patient willing to quit betel nut (betel nut and tobacco )quid chewing habit.
3)Patients willing to report for routine follow-up and also to undergo histo-pathological evaluation, blood investigations and continued oral physiotherapy as per the study protocol.
|
|
| ExclusionCriteria |
| Details |
1)Patients with Grade IV OSMF indicated for surgery
2)Prior H/O treatment for OSMF, Trauma,burns/sleroderma
3)Pregnant ladies, lactating mothers or those planning to conceive in the next 2 years.
4)Edentulous patients
5)Patients with h/o allergy to sea-food/ astaxanthin, lycopene, beta-carotene, selenium ,minerals,etc.
6)Patients with prior h/o radiotherapy, corticosteroid treatment,cardiovascular,liver or renal disorders
7)Patients with h/o bleeding disorders,auto-immune,diabetics,hypertensives,individuals with low calcium levels,asthmatics,iron metabolic disorders,thyroid disorders
8)Patients with severe obesity, h/o carbamazepine/phenytoin treatment, immuno-supressant,inflammatory bowel disease(due to effect on serum Ig A levels.) |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Reduction in trismus (evaluated by measuring the maximum inter-incisal distance ) in Grade I, II and III Oral
Submucous Fibrosis patients treated with either astaxanthin / Capsule SM Fibro(standard antioxidant drug-lycopene,beta-carotene) along with habit cessation and oral physiotherapy. |
The difference in the maximum inter-incisal opening in millimeters will be evaluated at the start of study,1 month, 2 months ,3 months and 6 months after treatment in both the study group and control group. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The following secondary outcomes will be evaluated in both study and control groups
1)Improvement in tongue protrusion |
The following secondary outcomes will be evaluated in both study and control 1)Improvement in tongue protrusion-evaluated by the maximum tongue protrusion in millimeters measured at the start of the study, 1 month, 2 months , 3 months and 6 months after the completion of drug therapy. |
| 2)Reduction in burning sensation and oral ulcers |
2)Reduction in burning sensation and oral ulcers -by VAS Score will be evaluated at the start of study,1 month, 2 months ,3 months and 6 months after treatment |
| 3)Improvement in cheek flexibility. |
3)Improvement in cheek flexibility by measuring the difference in maximum cheek flexibility in millimeters at the start of study,1 month, 2 months ,3 months and 6 months after treatment . |
| 4)Reduction in the histopathological grading of OSMF |
4)Reduction in the histopathological grading of OSMF according to Khanna and Andrade classification (1995), at the start of study and 3 months after drug therapy. |
| 5)Change in the serum IgA levels in mg/ml. |
5)Change in the serum IgA levels in mg/ml will be evaluated at the start of the study and 3 months after treatment. |
| 6)Adverse effects seen in patients after astaxanthin /Standard anti-oxidant Capsule SM Fibro administration |
6)Adverse effects seen in patients after astaxanthin /Standard anti-oxidant Capsule SM Fibro administration will be noted from the time of administration upto 2 weeks, at the first , second ,third month visit as also 6 months after completion of treatment . |
| 7)The impact of OSMF on quality of life |
7)The impact of OSMF on quality of life will be evaluated before treatment and at the end of treatment period(3 months ) using EORTC QLQ-35 .(European Organization for Research Training in cancer-Quality of life questionnaire-35) |
| 8)The effect of the drug based on the existing severity of disease |
The effect of the drug based on the existing severity of disease will be evaluated based on the maximum inter-incisal opening and clinical grading of OSMF at the start of study, at 1 month, 2 months , 3 months and 6 months post drug treatment . |
| 9)Improvement in all above mentioned parameters |
9)Improvement in all above mentioned parameters will be evaluated 6 months post treatment except for histo-pathological grading,
Serum IgA levels and EORTC Quality of life questionnaire which will be evaluated after 3 months |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
16/01/2026 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drjanicejohn1@gmail.com].
- For how long will this data be available start date provided 31-12-2027 and end date provided 30-06-2028?
Response (Others) - 6 months following article publication
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Title : Prospective assessment of the efficacy of astaxanthin-a novel carotenoid anti-oxidant drug as compared to standard anti-oxidant drug (Capsule SM Fibro-lycopene,beta-carotene ) in the management of Grade I,II and III OSMF patients aged 18-60 years: A double- blind ramdomised controlled clinical trial.OSMF is a highly prevalent disease in the Indian sub-continent with an alarming malignant transformation rate of about 4.2% ,as studied by Kujan O , Mello FW et al in 2021. The etiology being multifactorial , a number of medicinal and surgical approaches have been implemented.The role of oxidative stress in the etio-pathogenesis of this pre-malignant condition has been highlighted in a number of studies with elevated levels of malondialdehyde and 8-hydroxy-20 de-oxyguanosine found in a significant majority of these patients. The promising results obtained with anti-oxidants like lycopene, aloe-vera, curcumin, spirulina and capsules like SM-Fibro, Oxitard, etc have encouraged us to explore the potential of newer carotenoids like H. pluvialis derived super-antioxidant astaxanthin in mitigating the symptoms and intercepting the progress and malignant transformation in OSMF patients. Astaxanthin is also widely regarded for its potent anti-inflammatory, immuno-modulatory role via the transformation growth factor-beta 1 pathway.There is no literature available on the role of astaxanthin in OSMF patients with the only available clinical trial having no follow-up data or histopathological/ biomarker co-relation. In the present study , our primary purpose is to evaluate the efficacy of astaxanthin versus standard anti-oxidant capsule SM Fibro(lycopene, beta-carotene) in the management of GradeI,II and III OSMF patients planned for medicinal management alone. Patients who fulfill the inclusion and exclusion criteria will randomly (based on odd/even OPD no.)be alloted to the study/ control group and various parameters will be evaluated at routine intervals as per the study protocol. Patients in the study group will be treated with astaxanthin 4 mg BD for 3 months while those in the control group will be treated with Capsule SM Fibro(lycopene ,beta-carotene) for 3 months.Both groups will be advised oral physiotherapy and habit cessation too.Both investigator and patients will be meticulously kept blind to the treatment assignment. The null hypothesis of our study is : There is no statistically significant difference in the efficacy of Astaxanthin as compared to standard antioxidant drug (Capsule SM Fibro-lycopene, beta-carotene) in the management of Grade I, II and III OSMF patients .
The alternate hypothesis is : There is statistically significant difference in the efficacy of Astaxanthin as compared to standard antioxidant Capsule SM Fibro(lycopene, beta-carotene) in the management of Grade I,II and III OSMF patients. Various parameters like improvement in trismus,improvement in tongue protrusion, reduction in burning sensation, improvement in cheek flexibility, change in the serum IgA levels, change in the histopathological grading, impact of treatment on quality of life ,etc will be evaluated at the start of study and also at definite intervals .All patients will be kept on 6 month follow-up after treatment completion. The results obtained in the study will be subjected to appropriate statistical tests and data interpretation will be done and research paper published. All ethical guidelines related to data collection, informed consent, confidentiality will be strictly adhered to.
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