Formulation, and clinical efficacy of Zataria multiflora Boiss. capsules in mild to moderate Alzheimer disease: A double-blind randomized trial

Abstract

Objective

Alzheimer’s disease (AD), the leading cause of dementia, is a major contributor to disability among older adults, and effective treatments remain a significant challenge. Recent studies suggest that Zataria multiflora has antioxidant, anticholinesterase, and memory-enhancing capabilities. This study investigates the potential of edible plant capsules derived from Z. multiflora to reduce clinical symptoms in patients with mild to moderate AD.

Methods

A randomized, double-blind, placebo-controlled clinical trial was conducted in a Kerman nursing home between November 2019 and February 2020. Herbal capsules were formulated using a standardized extract of Z. multiflora with rigorous quality control. Seventy-two eligible participants (over 50 years old) were randomly assigned to either the intervention or placebo groups using randomized replacement blocks. The intervention group received 600 mg of the herbal capsules three times daily, while the placebo group received an identical placebo, both for 8 weeks. The primary outcomes were memory improvements, measured using Clinical Dementia Rating (CDR) and Mini-Mental State Examination (MMSE) scores at baseline, week 4, and week 8. Data was analyzed using SPSS version 23 with independent t-tests, chi-square, and Fisher’s exact tests for group comparisons. A significance level of p < 0.05 was used.

Results

Both groups showed statistically significant changes in mean CDR and MMSE scores from baseline to week 4, week 8, and also from week 4 to week 8. However, the intervention group had significantly greater improvements than the placebo group. A significant time-group interaction was observed in both CDR and MMSE assessments.

Conclusion

Despite the relatively short intervention period, which warrants further longer-term studies, the observed improvements in CDR and MMSE scores suggest that Z. multiflora may be a promising adjunctive treatment for individuals with AD. These findings support further research into the therapeutic potential of Z. multiflora in this context.