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.

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. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100292

Enrollment

114

Registered

2026-01-05

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: 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 cessati

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.)

Design outcomes

Primary

Measure	Time frame
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.Timepoint: 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.	—

Measure

Time frame

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.Timepoint: 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.

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Secondary

Measure	Time frame
The following secondary outcomes will be evaluated in both study and control groups 1)Improvement in tongue protrusionTimepoint: 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 ulcersTimepoint: 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.Timepoint: 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 OSMFTimepoint: 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.Timepoint: 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 administrationTimepoint: 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 lifeTimepoint: 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 diseaseTimepo	—

Measure

Time frame

The following secondary outcomes will be evaluated in both study and control groups 1)Improvement in tongue protrusionTimepoint: 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 ulcersTimepoint: 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.Timepoint: 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 OSMFTimepoint: 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.Timepoint: 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 administrationTimepoint: 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 lifeTimepoint: 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 diseaseTimepo

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Countries

India

Contacts

Public ContactDr Janice John

ACPM Dental College, Dhule

drjanicejohn1@gmail.com7875987109

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026