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Efficacy of Yashthimadhu Ghrita Gandusha in the Management of Oral Submucous Fibrosis: A Randomized Controlled Trial

Comparative Evaluation of Efficacy of Yashthimadhu Ghrita Gandusha with Lycopene and Triamcinolone Acetonide in the Management of Oral Submucous Fibrosis: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067449
Enrollment
90
Registered
2024-05-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

None listed

Sponsors

Romita Gaikwad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with age group between 20 and 60 years. 2. Clinically diagnosed patient of OSMF with Stage I, II, III. 3. Patients of both genders. 4. Patients who had not taken any treatment previously for OSMF. 5. Patients who are ready to leave the adverse habit of areca nut/betel quid/guthkha/kharra chewing and accepted to come for regular follow-up.

Exclusion criteria

Exclusion criteria: 1.OSMF patients with co-existing other mucosal lesions 2.Extensive fibrosis with severe trismus with an inter incisal distance 3.OSMF patients with the coexisting systemic illness. 4.Pregnant women and lactating mothers. 5.OSMF patients with premalignant and malignant changes.

Design outcomes

Primary

MeasureTime frame
1. To evaluate the alteration in Burning Sensation, Interincisal Mouth Opening and Cheek Flexibility associated with OSMF before and after the treatment with yashthimadhu ghrita gandusha. 2.To evaluate alteration in Burning Sensation, Interincisal Mouth Opening and Cheek Flexibility associated with OSMF before and after the treatment with yashthimadhu ghrita gandusha with systemic lycopene. Timepoint: Pre-operative Burning Sensation, Interincisal Mouth Opening and Cheek Flexibility will be measured. These clinical parameters will be measured and recorded at baseline, 1st and 2nd month. Patients will be recalled after every 15 days for follow-up.

Secondary

MeasureTime frame
To compare the effectiveness of yashthimadhu ghrita gandusha, systemic lycopene & topical triamcinolone acetonide in management of symptoms in OSMF. and To correlate efficacy of yashthimadhu ghrita gandusha according to clinical parameters of mouth opening, cheek flexibility & burning sensation. Timepoint: Pre-operative Burning Sensation, Interincisal Mouth Opening & Cheek Flexibility will be measured. These clinical parameters will be measured & recorded at baseline, 1st & 2nd month. Patients will be recalled after every 15 days for follow-up.

Countries

India

Contacts

Public ContactRomita Gaikwad

Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital

ashish.lanjekar@sdk-dentalcollege.edu.in9595052481

Outcome results

None listed

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