Using alternative (ayurvedic & herbal) medications for the treatment of an Oral Precancer Condition known as Oral Submucous fibrosis and to see how effective they are in comparison to currently prescribed steroid treatment.

Efficacy of Aloe Vera gel, Spirulina tablet and topical curcumin in management of Oral Submucous Fibrosis: A Randomized Controlled Trial - RACOTR

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028666

Enrollment

140

Registered

2020-10-27

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: Triamcinolone acetonide : Topical Steroid (Triamcinolone acetonide 0.1%) Thrice daily application for 3 months Control Intervention1: Aloe Vera gel: Aloe Vera gel (90% conc. 5mg bid fo

Eligibility

Inclusion criteria

Inclusion criteria: Patient with the clinical sign and symptoms suggestive of Grade II Oral Submucous Fibrosis (Khanna and Andrade Classification) above the age of 12 years. Patients who are willing to quit the habit of areca nut or related product. A patient who has never been on any form of medicinal treatment for oral submucous fibrosis

Exclusion criteria

Exclusion criteria: Pregnant women and lactating mothers. Patient who have a known allergy to Aloe Vera, Spirulina (sea foods). Patient with missing incisors Patient with diseases causing fibrosis such as scleroderma, severe anemia, cicatricial pemphigoid, post radiotherapy changes, post surgical sclerosis, etc.

Design outcomes

Primary

Measure	Time frame
(1) Interincisal distance on maximum mouth opening with the help of a digital Vernier caliper in millimeters (mm). (2) Burning sensation on taking spicy food or hot temperature liquids will be recorded using a Numerical Rating Scale (NRS) (3) Tongue protrusion will be measured with the help of two scales. (4) fibrous bands palpated as mild/moderate/severe (5) Cheek FlexibilityTimepoint: 3 months	—

Secondary

Measure	Time frame
(1) Interincisal distance on maximum mouth opening with the help of a digital Vernier caliper in millimeters (mm). (2) Burning sensation on taking spicy food or hot temperature liquids will be recorded using a Numerical Rating Scale (NRS) (3) Tongue protrusion will be measured with the help of two scales. (4) fibrous bands palpated as mild/moderate/severe (5) Cheek FlexibilityTimepoint: at every 2 weeks	—

Measure

Time frame

(1) Interincisal distance on maximum mouth opening with the help of a digital Vernier caliper in millimeters (mm). (2) Burning sensation on taking spicy food or hot temperature liquids will be recorded using a Numerical Rating Scale (NRS) (3) Tongue protrusion will be measured with the help of two scales. (4) fibrous bands palpated as mild/moderate/severe (5) Cheek FlexibilityTimepoint: at every 2 weeks

—

Countries

India

Contacts

Public ContactSunil Surendraprasad Mishra

Rural Dental College, Loni

anitakarle7@gmail.com9960449292

Outcome results

None listed

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