Health Condition 1: K135- Oral submucous fibrosis
Conditions
Interventions
Intervention1: Habb-eMaghz-e-Badam: Habb-eMaghz-e-Badam is made up of Alsi(Link usitatissimum), Rub-us-Soos Siyah(Glycyrrhiza glabra), Filfil(Piper nigrun), Gond Keekar(Acacia Nilotica), Might-e-Badam
Sponsors
Dr Arvind Kumar Kairo
Dr Alok Thakar
Dr Deepika Mishra
Dr Pooja Gupta
Dr Rakesh Kumar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 18 years , either gender. 2. Treatment naive patients diagnosed with stage 1,2 and 3 OSF. 3. Stage 1 OSF > 35 mm with other clinical features of OSF. 4. Stage 2 OSF -26-35 mm 5. Stage 3 OSF -15-26 mm 6. Patients who will give consent and agree to continue follow up for 1 year.
Exclusion criteria
Exclusion criteria: 1. Histopathological evidence of premalignant conditions, dysplasia, malignancy or systemic diseases causing burning sensation of mouth, ulceration or reduction in mouth opening like systemic ulceration. 2. Patients suffering from medically compromised conditions like tuberculosis, HIV, renal and hepatic diseases etc. 3. Pregnant and lactating women. 4. Patients with history of intake drugs known to cause fibrosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Increase in inter-incisal distance in mm(I.e. increase in mouth opening)Timepoint: After 3 and 6 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Increase in cheek flexibility in mm. 2. Decrease in subjective symptoms a. Burning sensation of buccal mucosa by visual analog scale b. Tightness of buccal mucosa by visual analogue scale. 3. Improvement in histopathological profile in terms of decrease in collagen deposition. 4. Changes in Biomarker level TGF-Beta, TNF-alfa, alfa-SMA, and IL-1Beta in oral mucosal biopsy/FNAC 5. Treatment related adverse events Timepoint: After 3 and 6 months of treatment | — |
Countries
India
Contacts
Public ContactDr Arvind Kumar Kairo
AIIMS, New Delhi
Outcome results
None listed