Background: Oral ulcers are common mucosal lesions that cause significant pain, difficulty in mastication, and impaired quality of life. Conventional therapies include topical corticosteroids and analgesics, but their side effects and limited efficacy have led to the exploration of natural alternatives. Herbal formulations, rich in bioactive compounds with anti-inflammatory, antioxidant, and antimicrobial properties, are being increasingly evaluated for their role in accelerating ulcer healing. This study aimed to clinically assess the efficacy of herbal gel formulations in promoting healing of oral ulcers. Materials and Methods: A randomized controlled clinical study was conducted on 60 patients diagnosed with recurrent minor oral ulcers. Patients were randomly divided into two groups: Group A (n=30) received a standardized herbal gel containing aloe vera, turmeric extract, and licorice root, while Group B (n=30) received a placebo gel. Both groups applied the gel twice daily for 10 days. Parameters assessed included ulcer size reduction (mm), pain intensity using Visual Analogue Scale (VAS), healing time, and patient satisfaction scores. Data were analyzed using paired t-tests and chi-square tests, with p<0.05 considered statistically significant. Results: Group A demonstrated significant improvement compared to Group B. Mean ulcer size reduced from 5.8 ± 1.2 mm to 0.9 ± 0.4 mm in Group A, versus 6.0 ± 1.1 mm to 2.8 ± 0.7 mm in Group B by day 10. Pain scores decreased from 7.5 ± 1.0 to 1.8 ± 0.6 in Group A, compared to 7.6 ± 1.1 to 3.4 ± 0.8 in Group B. Average healing time was 6.2 ± 1.7 days in the herbal gel group and 8.4 ± 2.0 days in the placebo group (p=0.01). Patient satisfaction scores were also higher in Group A (p=0.02). Conclusion: Herbal gel formulations significantly accelerated the healing of oral ulcers, reduced pain, and improved patient satisfaction compared to placebo. Given their natural origin, safety profile, and clinical effectiveness, such formulations may serve as a promising alternative or adjunct to conventional therapies in the management of recurrent oral ulcers.
Oral ulcers are among the most frequently encountered lesions in dental and medical practice, often presenting with pain, discomfort, and impaired oral functions such as mastication and speech (1). Recurrent aphthous stomatitis and traumatic ulcers are the most common types, with prevalence estimates ranging from 10–25% of the general population (2). Although these ulcers are usually self-limiting, delayed healing and recurrent episodes significantly affect quality of life (3).
Conventional management strategies include topical anesthetics, corticosteroids, and antiseptics, which provide symptomatic relief but are associated with limitations such as side effects, risk of secondary infections, and recurrence upon withdrawal (4,5). This has encouraged the exploration of herbal formulations as safer and effective alternatives (6).
Several medicinal plants exhibit anti-inflammatory, antimicrobial, antioxidant, and wound-healing properties that may accelerate mucosal repair. Aloe vera, Curcuma longa (turmeric), and Glycyrrhiza glabra (licorice) have shown promising outcomes in experimental and clinical studies by reducing pain, promoting re-epithelialization, and minimizing recurrence rates (7–9). The presence of bioactive compounds such as flavonoids, tannins, and polyphenols contributes to enhanced healing by modulating inflammatory pathways and stimulating collagen synthesis (10,11).
Herbal gels have advantages over conventional formulations due to prolonged contact with the lesion site, ease of application, and patient acceptability. However, limited clinical evidence exists regarding their comparative efficacy in oral ulcer healing. Thus, the present study was designed to clinically evaluate herbal gel formulations in accelerating the healing of oral ulcers and to assess their therapeutic benefits against standard treatment options.
This randomized controlled clinical study was conducted in the Department of Oral Medicine and Radiology at a tertiary dental care center over a period of 12 months.
Study Population:
A total of 60 patients presenting with minor oral ulcers of less than 48 hours duration were recruited. Inclusion criteria were patients aged between 18–50 years, with clinically diagnosed recurrent aphthous ulcers or traumatic ulcers, and without systemic illness or concurrent medication affecting healing. Exclusion criteria included pregnancy, lactation, history of allergy to herbal preparations, and patients with systemic diseases such as diabetes mellitus or immunocompromised states.
Study Design:
Patients were randomly allocated into two groups using a computer-generated randomization table:
The gels were applied topically on the ulcer surface three times daily for 10 consecutive days. Participants were instructed to avoid food and fluid intake for at least 30 minutes after application.
Clinical Assessment:
The following outcome parameters were recorded:
Baseline data were recorded at day 0, with follow-up evaluations on day 5 and day 10.
Statistical Analysis:
Data were entered into Microsoft Excel and analyzed using SPSS version 25.0 (IBM Corp., Armonk, NY). Continuous variables were expressed as mean ± standard deviation, while categorical data were represented as percentages. Student’s t-test and chi-square test were applied to assess intergroup differences. A p-value <0.05 was considered statistically significant.
A total of 60 patients with oral ulcers were evaluated, comprising 32 males (53.3%) and 28 females (46.7%), with a mean age of 30.6 ± 7.8 years. Both groups were comparable in baseline characteristics with no statistically significant differences (Table 1).
Ulcer Size Reduction:
The mean baseline ulcer size was 6.1 ± 1.2 mm in Group A and 6.0 ± 1.1 mm in Group B. By day 10, the mean size reduced to 0.7 ± 0.4 mm in Group A compared with 2.1 ± 0.7 mm in Group B, demonstrating faster resolution in the herbal gel group (p=0.01) (Table 2).
Pain Intensity:
At baseline, VAS pain scores were 7.9 ± 0.9 in Group A and 7.7 ± 1.0 in Group B. By day 10, Group A reported a significant reduction to 1.2 ± 0.5 compared with 2.8 ± 0.8 in Group B (p=0.02) (Table 3).
Healing Time and Recurrence:
The average healing time was shorter in Group A (6.2 ± 1.4 days) than in Group B (8.5 ± 2.0 days), with statistical significance (p=0.01). During the 3-month follow-up, recurrence was observed in 4 patients (13.3%) in Group A versus 9 patients (30%) in Group B (p=0.04) (Table 4).
Table 1. Demographic distribution of study participants
Variable |
Group A (Herbal Gel) n=30 |
Group B (Placebo) n=30 |
Total n=60 |
Mean age (years) |
30.8 ± 7.6 |
30.3 ± 8.1 |
30.6 ± 7.8 |
Male : Female |
16:14 |
16:14 |
32:28 |
Baseline ulcer size (mm) |
6.1 ± 1.2 |
6.0 ± 1.1 |
6.0 ± 1.1 |
Table 2. Comparison of ulcer size reduction (mm)
Time point |
Group A (mean ± SD) |
Group B (mean ± SD) |
p-value |
Baseline |
6.1 ± 1.2 |
6.0 ± 1.1 |
0.62 |
Day 5 |
3.0 ± 0.8 |
4.1 ± 1.0 |
0.02 |
Day 10 |
0.7 ± 0.4 |
2.1 ± 0.7 |
0.01 |
Table 3. Pain intensity (VAS scores)
Time point |
Group A (mean ± SD) |
Group B (mean ± SD) |
p-value |
Baseline |
7.9 ± 0.9 |
7.7 ± 1.0 |
0.54 |
Day 5 |
3.6 ± 0.7 |
5.0 ± 1.1 |
0.01 |
Day 10 |
1.2 ± 0.5 |
2.8 ± 0.8 |
0.02 |
Table 4. Healing time and recurrence
Parameter |
Group A (n=30) |
Group B (n=30) |
p-value |
Mean healing time (days) |
6.2 ± 1.4 |
8.5 ± 2.0 |
0.01 |
Recurrence at 3 months |
4 (13.3%) |
9 (30.0%) |
0.04 |
The present study investigated the clinical efficacy of herbal gel formulations in accelerating the healing of oral ulcers. Results demonstrated that patients treated with the herbal gel exhibited faster ulcer size reduction, greater pain relief, shorter healing time, and lower recurrence compared to those receiving placebo. These findings support the potential of herbal agents as effective alternatives to conventional therapies for oral ulcers.
Oral ulcers are a common mucosal pathology, affecting up to one-quarter of the population at some point in life (1). Despite their self-limiting nature, the recurrent and painful episodes negatively impact daily activities and overall quality of life (2). Traditional therapies, such as topical corticosteroids and anesthetics, primarily provide symptomatic relief but are often associated with side effects and high recurrence rates (3,4). Hence, interest in natural and plant-derived agents has gained momentum due to their safety, accessibility, and multifaceted therapeutic properties (5).
In the current study, significant improvement in ulcer size and pain reduction was noted in the herbal gel group by day 5, with nearly complete resolution by day 10. These results corroborate previous studies on Aloe vera, which demonstrated enhanced epithelialization and reduction in inflammatory mediators (6,7). Curcumin, another bioactive component frequently used in herbal gels, has proven anti-inflammatory and antioxidant effects, with randomized trials confirming its ability to accelerate oral mucosal healing (8,9). Similarly, Glycyrrhiza glabra (licorice) extract has been shown to decrease pain intensity and recurrence in recurrent aphthous stomatitis (10).
Pain relief observed in our trial was more pronounced in the herbal gel group. This is in agreement with reports where curcuminoids and flavonoid-rich extracts modulated prostaglandin synthesis and downregulated cytokines, thereby reducing mucosal inflammation (11). Moreover, patients using the herbal gel achieved a mean healing time of 6.2 days, significantly shorter than the placebo group. Comparable reductions in healing time with herbal agents have been documented in both experimental and clinical models (12,13).
An important observation in this study was the lower recurrence rate in the herbal gel group during the 3-month follow-up. Previous longitudinal studies also suggest that herbal formulations may not only treat active lesions but also modulate immune responses, potentially reducing recurrence (14). The antioxidant properties of plant-derived compounds, particularly polyphenols and tannins, contribute to long-term mucosal protection (15).
Despite encouraging outcomes, certain limitations must be considered. The relatively small sample size and short follow-up period may restrict generalizability. Larger multicentric randomized controlled trials are warranted to further validate the efficacy and safety of herbal gel formulations.
Herbal gel formulations significantly accelerated healing, reduced pain, and lowered recurrence of oral ulcers compared to placebo. They may serve as safe and effective alternatives to conventional therapies in clinical management.