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To observe the Effect of a Gel containing Curcumin, Tulsi And Yashtimadhu in sufferers of ghutka chewers.

Evaluation Of Effectiveness Of Commercially Available Topical Gel With Curcumin, Tulsi And Yashtimadhu In Clinical Management Of Oral Submucous Fibrosis Patients: A Prospective Clinical Study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/102352
Enrollment
42
Registered
2026-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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: Tezrec Gel for 3 months: Commercially Available Tezrec Topical Gel With Curcumin, Tulsi And Yashtimadhu Control Intervention1: Baseline: when the patient comes for the 1st visit (0 wee

Sponsors

Graciera Pharmaceuticals LLP
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinically diagnosed Cases of oral submucous fibrosis. 2. Patients those who are not willing to undergo surgical intervention and intralesional injections for the treatment of OSMF. 3. Patients who are able to apply the gel even with restricted mouth opening 4. OSMF Patients who are willing to participate in study.

Exclusion criteria

Exclusion criteria: 1. OSMF patients with other OPMDs . 2. Patients undergoing treatment for OSMF. 3. Patients of OSMF with Oral squamous cell carcinoma . 4. Patients who are not willing to participate.

Design outcomes

Primary

MeasureTime frame
To evaluate the effectiveness of commercially available topical gel with curcumin, tulsi and yashtimadhu in clinical management of burning sensation, mouth opening, tongue protrusion and mouth flexibility of oral submucous fibrosis patients.Timepoint: 0 week 12 weeks

Secondary

MeasureTime frame
To evaluate the effectiveness of commercially available topical gel with curcumin, tulsi and yashtimadhu in clinical management of burning sensation, mouth opening, tongue protrusion and mouth flexibility in different clinical grades of oral submucous fibrosis patients.Timepoint: 0 week 12 weeks

Countries

India

Contacts

Public ContactDr Kamlesh Dekate

MGM Dental College and Hospital

dr.kamleshdekate@gmail.com9223290372

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026