DaburInclusion
History of allergy, recurrent viral throat infections or recurrent bacterial infection.
Exclusion
Serious systemic disorders, tuberculosis, chronic illness or participation in another clinical trial.
Clinical Study 1 · Open-label · N = 40
Evaluation of DCP in Nasal Allergies and Viral Infections
An open-label clinical study was conducted to evaluate the immunity-enhancing activity of DCP and its potential role in respiratory health, particularly recurrent cough and cold. Subjects were categorized according to normal status, allergy, viral infection and bacterial infection.
Serum total IgE at 12 weeks
30 of 40
subjects showed a reduction in serum IgE
Study population
40
total subjects, 16 to 65 years of age; 29 males, 11 females
Intervention
DCP
12 g orally, twice daily
Duration
12 weeks
Assessments at baseline, 6 weeks and 12 weeks
Groups
4 × 10
Normal, Allergy, Viral infection, Bacterial infection
Study population
A total of 40 subjects were included, with 10 subjects in each of four groups:
The subjects were reported to be 16–65 years of age, with 29 males and 11 females. The broader eligibility description included subjects with a history of allergy, recurrent viral throat infections or recurrent bacterial infection. Subjects with serious systemic disorders, tuberculosis, chronic illness or participation in another clinical trial were excluded.
10
Normal
10
Allergy
10
Viral infection
10
Bacterial infection
Methods
Assessment parameters
The study included clinical and laboratory assessments including:
- Clinical symptoms and respiratory complaints
- Serum total IgE
- Serum IgG
- Complement C3 and C4
- Haemoglobin
- ESR
- Sputum culture in the bacterial-infection group
- Other standard laboratory assessments
Serum IgE was quantified using an ELISA-based method, while IgG, C3 and C4 were assessed by immunoturbidimetric analysis.
Results
At 12 weeksReported percentage reductions in serum IgE from baseline at 12 weeks, by group.
A reduction in serum IgE was reported in 30 of 40 subjects.
ESR decreased in the normal, allergic and viral groups, while a small increase was reported in the bacterial group.
Haemoglobin increased in the allergic, bacterial and viral groups, while the normal group showed a decrease attributed in the source to one subject.
IgE decreased in all groups except the viral group; the decrease was statistically significant in the bacterial group according to the source. C3 decreased across the groups, while C4 decreased in the recurrent cough/cold groups but not in the normal group. The source itself notes considerable variability in C3/C4 results and indicates that larger studies would be required for further evaluation.
An improvement in quality-of-life parameters was also reported, with the greatest overall improvement reported in the allergic group.
- ESR
- Decreased in Normal, Allergy and Viral groups; small increase in Bacterial group.
- Haemoglobin
- Increased in Allergy, Bacterial and Viral groups; decrease in Normal group, attributed to one subject.
- IgG
- Decreased in all groups except Viral; statistically significant decrease in Bacterial group.
- Complement C3
- Decreased across all groups; considerable variability noted.
- Complement C4
- Decreased in recurrent cough and cold groups; no change in Normal group.
- Clinical outcomes
- Improvement in quality-of-life parameters reported in all groups. Greatest overall improvement observed in the Allergy group.
Clinical interpretation
The study provides preliminary clinical evidence of favourable changes in selected immunological, inflammatory and clinical parameters following DCP administration in subjects with recurrent respiratory/allergic complaints. The results demonstrated notable reduction in serum IgE and improvement in selected clinical parameters.
Key takeaway
DCP at 12 g twice daily for 12 weeks showed promising immunomodulatory and clinical benefits, particularly in subjects with allergies.
- Open-label study; each group included 10 subjects, total n = 40.
- Findings support the potential role of DCP in respiratory health; larger studies are required for further validation.