TO STUDY EFFICACY OF SPIRULINA AND LYCOPENE ALONG WITH INTRALESIONAL CORTICOSTEROID INJECTION THERAPY IN THE MANAGEMENT OF LIMITED MOUTH OPENING DUE TO ORAL SUBMUCOUS FIBROSIS- A PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL.

COMPARATIVE EVALUATION OF EFFICACY OF SPIRULINA AND LYCOPENE AS AN ADJUVANT TO INTRALESIONAL CORTICOSTEROID INJECTION THERAPY IN THE MANAGEMENT OF ORAL SUBMUCOUS FIBROSIS- A PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/05/033492

Enrollment

Registered

2021-05-10

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: Capsule spirulina 500 mg once daily orally with 1 ml triamcinolone acetonide (40mg/ml)injection given intralesional half dose on each side at weekly interval for 8 weeks.: spirulina has

Eligibility

Inclusion criteria

Inclusion criteria: 1.Clinically Diagnosed Grade III Oral Submucous Fibrosis patients. 2.Patients between the Age group of 21 - 50 years and both the sexes. 3.Patients not willing to undergo surgical management for the same. 4.Patients with no contraindications or documented allergies to the drugs which are being used for study. 5.Patients who are ready to quit the habits. Patients willing to participate in the study. 6.Patients ready to co-operate with the study and postoperative follow up.

Exclusion criteria

Exclusion criteria: 1.Patient unwilling to participate in study. 2.Patient not willing to quit habit. 3.Previously treated patients or those who have left treatment in-between, or undergoing any other treatment modality. 4.Patients with co-existing systemic illness. 5.Pregnant and lactating mother.

Design outcomes

Primary

Measure	Time frame
To compare the clinical response of lycopene and spirulina in patients suffering from oral submucous fibrosis in terms of increase in mouth opening measured mm by boleyâ??s gauge and cheek flexibility measured in mm by Mathur and Jha method and subjective assessment of reduction in burning sensation, palpable fibrous bands and recurrent ulceration measured weekly for 6 to 8 weeks followed by 3 month and 6month post-operative follow up.Timepoint: On assigned follow up visits	—

Measure

Time frame

To compare the clinical response of lycopene and spirulina in patients suffering from oral submucous fibrosis in terms of increase in mouth opening measured mm by boleyâ??s gauge and cheek flexibility measured in mm by Mathur and Jha method and subjective assessment of reduction in burning sensation, palpable fibrous bands and recurrent ulceration measured weekly for 6 to 8 weeks followed by 3 month and 6month post-operative follow up.Timepoint: On assigned follow up visits

—

Secondary

Measure	Time frame
ï?? To assess the benefits of adding adjuvant to intralesional corticosteroid therapy in management of oral submucous fibrosis.Timepoint: On assigned follow up visits	—

Countries

India

Contacts

Public ContactDrAsha Ramnath Chowdhar

Govt.Dental College And Hospital Mumbai.

dr.kavitawadde@gmail.com9004799405

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026