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Benefits of Matcha green tea for the treatment of Oral submucous fibrosis

Evaluation of effectiveness of Matcha green tea in the management of oral submucous fibrosis as compared to lycopene – A Randomised controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/059195
Enrollment
70
Registered
2023-10-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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 Health Condition 2: L988- Other specified disorders of the skin and subcutaneous tissue

Interventions

Intervention1: Matcha Green tea: Dose-800 mg Frequency - Twice a day Route of administration-Oral Total duration -3 months Control Intervention1: Lycopene: Dose- 5000mcg Frequency- Twice a day Route

Sponsors

DrAyush Dahiwade
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -OSMF patients in the age group 18 - 60 years diagnosed clinically -Patients in INTERINCISAL OPENING RANGE of 15-35 mm10 -No history of prior treatment for the same. -Patient willing for habit cessation and visit the hospital for regular follow up.

Exclusion criteria

Exclusion criteria: •Patients with systemic disease. •Patients with trismus due to other reason (pericoronitis,abscess). •Pregnant and lactating mother •Presence of other premalignant lesion (leukoplakia , oral lichen planus) or malignancy. •History of hypersensitivity to green tea or any of its components.

Design outcomes

Primary

MeasureTime frame
-Increase in Maximal interincisal opening -Reduction of burning sensation on the VAS scale -Increase Tongue protrusion (mm)Timepoint: 1.At base line 2.1 Week 3.2 Week 4.4 Week 5.2 Month 6.3 Month

Secondary

MeasureTime frame
SIDE EFFECTS OF INTERVENTION,IF ANYTimepoint: 1.At base line 2.1 Week 3.2 Week 4.4 Week 5.2 Month 6.3 Month

Countries

India

Contacts

Public ContactDr Ashita Kalaskar

Government Dental College and Hospital, Nagpur

kalaskarashita@gmail.com842585757

Outcome results

None listed

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