Cow-urine based topical herbal product for patients with reduced mouth opening due to fibrosis.

Assessment of cow-urine based topical herbal formulation in patients with oral sub-mucous fibrosis. - OSMF

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/02/017794

Enrollment

Registered

2019-02-25

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: K00-K14- Diseases of oral cavity and salivary glands

Interventions

Intervention1: cow urine: cow urine based gel formulation will be prepared Control Intervention1: Triamcinolane acetonide 0.1%: standard drug used for inflammatory conditions triamcinolane acetonide 0

Eligibility

Inclusion criteria

Inclusion criteria: 1.Individuals willing to participate in the study. 2.Individuals willing to quit addiction of tobacco and areca nut in any form. 3.Individuals not taking any prior medication for OSMF.

Exclusion criteria

Exclusion criteria: 1.Individuals with evidence of severe psychiatric disorders. 2.Individuals with cardiac disorders. 3.Individuals with gastrointestinal disorders. 4.Individuals with metabolic disorders. 5.Pregnant Females. 6.Lactating females.

Design outcomes

Primary

Measure	Time frame
Increased mouth opening. Decreased burning sensation by administration of topical herbal formulation.Timepoint: Interincisal distance in millimeters.	—

Secondary

Measure	Time frame
Burning sensation of mucosaTimepoint: Visual analogue scale	—

Countries

India

Contacts

Public ContactDr Aniket Vijay Dhote

Jaipur Dental College

dhoteaniket21@gmail.com7038816330

Outcome results

None listed

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