Effectiveness of Moringa Oliefera Capsules in Oral Sub Mucous Fibrosis.

Comparative Evaluation of Effectiveness of Moringa Oliefera Capsules and Lycopene Capsules in the Management of Oral Submucous Fibrosis – A Randomized Controlled Trial. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/077144

Enrollment

Registered

2024-11-20

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

None listed

Interventions

Intervention1: Multivitamin capsules: lycopene capsules 5 mg Per Day Orally BD Control Intervention1: Natural ayurvedic capsules: Moringa oliefera capsules 500mg Orally BD

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients in INTERINCISAL OPENING RANGE of 15-35mm. oral sub mucous fibrosis grade1,2,3 acc.to Khanna and Andrade classification (1995). 2.No history of prior treatment for the same. 3.Patient willing for habit cessation and visit the hospital for regular follow up.

Exclusion criteria

Exclusion criteria: 1.Patients with systemic disease. 2.Patients with trismus due to other reason (pericoronitis, abscess). 3.Presence of other premalignant lesion (leukoplakia, oral lichen planus) or malignancy. 4.History of hypersensitivity to moringa oliefera and its components. 5.Any tongue abnormalities and disorders. 6.Missing upper and lower central incisors 7.Pregnant and lactating mothers.

Design outcomes

Primary

Measure	Time frame
Evaluation of the following Parameters 1.Maximal interincisal opening using Vernier Caliper. 2.Reduction of burning sensation on the VAS scale 3.Increase in tongue protrusion measured by using steel scale. 4.Cheek flexibility.Timepoint: Patients will be recalled at the end of 1st week ,2nd week ,4th week, at the end of 2nd month and 3rd month. Post treatment follow up will be done on monthly basis for three months.	—

Measure

Time frame

Evaluation of the following Parameters 1.Maximal interincisal opening using Vernier Caliper. 2.Reduction of burning sensation on the VAS scale 3.Increase in tongue protrusion measured by using steel scale. 4.Cheek flexibility.Timepoint: Patients will be recalled at the end of 1st week ,2nd week ,4th week, at the end of 2nd month and 3rd month. Post treatment follow up will be done on monthly basis for three months.

—

Secondary

Measure	Time frame
side effects of intervention if anyTimepoint: Patient will be recalled at the end of 1st week, 2nd week, 4th week, At the end of 2nd month and At the end of 3rd month. Post Treatment follow up on monthly basis for three months.	—

Countries

India

Contacts

Public ContactDr M Kavinraj

Government Dental College and Hospital Nagpur.

amit_parate11@rediffmail.com9370998219

Outcome results