Clinicobiochemical evaluation of turmeric with black pepper and nigella sativa in management of oral submucous fibrosis-a double-blind, randomized preliminary study.
- 2016-12
- Oral surgery, oral medicine, oral pathology and oral radiology 122(6)
- Pratik R Pipalia
- Rajeshwari G Annigeri
- Ranjeeta Mehta
- PubMed: 27720650
- DOI: 10.1016/j.oooo.2016.07.023
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Population
- 40 OSMF patients
- Methods
- Double-blind, randomized design. Group A received turmeric with black pepper and group B received nigella sativa for 3 months. Clinical evaluation every 15 days. Serum SOD levels assessed before and after treatment.
- Blinding
- Double-blind
- Duration
- 3 months
- Funding
- Unclear
Objective
To investigate the effectiveness of turmeric with black pepper and nigella sativa in oral submucous fibrosis (OSMF).Study design
Forty OSMF patients were randomly divided into two groups. The study was performed under a double-blind, randomized design. Group A received turmeric with black pepper and group B received nigella sativa for 3 months. Clinical evaluation was done every 15 days. Patients' serum superoxide dismutase (SOD) levels were assessed before and after treatment and also compared with healthy controls. The response to treatment was analyzed using analysis of variance, paired t test, and unpaired t test.Results
After the treatment, groups A and B showed 3.85 ± 0.22 mm and 3.6 ± 0.07 mm improvement in mouth opening, respectively (P < .01); 87.90% and 78.91% reduction in burning sensation, respectively (P < .01); and +0.62 U/mL and +0.74 U/mL improvement in serum SOD levels, respectively (P < .05). The maximum mouth opening achieved was 8 mm in group A and 7 mm in group B. The mean pretreatment SOD level for controls and patients was 3.61 ± 0.24 U/mL in group A and 2.63 ± 0.18 U/mL in group B.Conclusion
Turmeric with black pepper and nigella sativa improved mouth opening, burning sensation, and SOD levels in the present OSMF study patients; however, further investigations are needed.Research Insights
After the treatment, groups A and B showed 3.85 ± 0.22 mm and 3.6 ± 0.07 mm improvement in mouth opening, respectively (P < .01)
- Effect
- Beneficial
- Effect size
- Small
+0.62 U/mL and +0.74 U/mL improvement in serum SOD levels, respectively (P < .05)
- Effect
- Beneficial
- Effect size
- Small
87.90% and 78.91% reduction in burning sensation, respectively (P < .01)
- Effect
- Beneficial
- Effect size
- Large