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To check Effectivess of lycopene therapy versus cryotherpay for the treatment of oral leukoplakia

â??Evaluation of short term treatment outcome after systemic lycopene therapy versus cryotherapy in management of oral leukoplakia: - a randomized parallel group trial".

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/04/006827
Enrollment
100
Registered
2016-04-18
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: null- Patient with biopsy proven cases of oral leukoplakia

Interventions

Intervention1: lycopene,cryotherapy: In group A Lycopene preparation will be prescribed in the dosage of 4 mg twice daily for 3 month, In group B Cryotherapy was done according to standard procedure I

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All healthy male and female between 15-60 years having oral leukoplakia (biopsy proven) reporting to department of oral and maxillofacial surgery , CDER AIIMS 2. Patients having size of primary lesion more than 1 cm. 3. Patient having history of tobacco chewing/smoking.

Exclusion criteria

Exclusion criteria: 1. Patient having white lesion with negative history of tobacco use. 2. Patients with lesion of size less than 1 cm. 3. Patients with lesion associated with ulcero-proliferative growth or suspicious of squamous cell carcinoma. 4. Patients who are nursing or pregnant. 5. Patients with uncontrolled systemic disease. 6. Patient who are allergic to tomato and food products containing tomato extracts. 7. Patient not willing to quit the adverse habit. 8. Patient refuses to give consent.

Design outcomes

Primary

MeasureTime frame
To compare clinical response (reduction in size of leukoplakia patch) after lycopene therapy and cryotherapy in the management of oral leukoplakia.Timepoint: after 1 month and 3 month

Secondary

MeasureTime frame
To see for the presence of any new localization/recurrence after therapyTimepoint: evaluation to be done after 3 month and 6 months

Countries

India

Contacts

Public ContactDr Gaurav Jain

AIIMS (Autonomous)

dr_ongkila@rediffmail.com9868397735

Outcome results

None listed

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