Clinical trial in Oral Sub Mucous Fibrosis patients

A randomized, double-blind, active controlled, parallel-group, clinical study to evaluate the efficacy and safety of poly herb gel in treatment of clinically diagnosed stage I and Stage II Oral Sub Mucous Fibrosis. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/080269

Enrollment

100

Registered

2025-02-10

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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: Poly herb gel (SQUA Care Gel): Topical application of herbal gel 2 gm 2 to 3 times daily to be applied on affected area of the mouth for 12 weeks. Control Intervention1: Plain Water alo

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patient who are clinically diagnosed with OSMF aged between 18 to 65 years 2. OSMF with grade I, and II will be included without any underlying comorbidities 3. Patients who are ready to quit the habit of betel quid/ areca nut/ gutkha chewing and are willing for regular follow-ups. 4. Must be willing and able to give informed consent and comply with the study procedures

Exclusion criteria

Exclusion criteria: 1. Debilitating diseases such as carcinoma. 2. Patients contraindicated for steroids. 3. Patients with other mucosal disorders with clinical features same as OSF (such as: trismus due to Temporomandibular Joint Dysfunction, pericoronitis, space infection, history of surgery or trauma, systemic sclerosis, amyloidosis, iron deficiency anemia, radiation therapy). 4. Patients who were under treatment or have had already undergone treatment for OSF. 5. The patients with history of hypersensitivity to hyaluronidase. 6. Patients with history of hypersensitivity to herbal drugs 7. Patients with OSMF of Grade III and IV 8. Patients already on systemic steroids 9. Pregnant and lactating mothers. 10. Disease is most advanced with premalignant and malignant changes

Design outcomes

Primary

Measure	Time frame
1. The mean improvement in interincisal mouth opening 2.The mean improvement in cheek flexibility 3.The mean improvement in tongue protrusion Timepoint: Day 0 Day 30 Day 60 and Day 90	—

Secondary

Measure	Time frame
1. Pain VAS 2. OSMF questionnaire 3. Pain/Burning sensation 4. Interincisal 5. mouth opening 6. Tongue protrusion 7. Difficulty in swallowing 8. Ulcerations 9. Swelling 10. SF-36 Questionnaire Timepoint: Day 0 Day 30 Day 60 and Day 90;Salivary Biomarkers (SImmunoglobulins) Haematology Biochemistry Timepoint: Day 0 and Day 90	—

Countries

India

Contacts

Public ContactSri H Srinivas

Natureorama Private Limited

sreenivas.drugs@gmail.com9448080317

Outcome results

None listed

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