Herbal medicine and drug substitution: report on lagundi, yerba buena and akapulko. vol. 2.

A phase 3 clinical trial using the randomized, double-blind, placebo-controlled sought to determine the efficacy, safety, and acceptability of lagundi (Vitex negundo) tablets. The subjects were patients who were otherwise healthy except for complaints of acute nonbacterial cough of mild to moderate severity as defined in the protocol, with no previous cough medications within two days of consultations. Evaluation of patients every three days gave the following results: Lagundi treatment acute cough of nonbacterial etiology effectively decreased the frequency of coughing in children of all groups and improved the color of phlegm in older children by the third day of dosing. With placebo treatment, cough frequency decreased by the sixth day. No adverse effects were noted or reported by the children or their guardians, and both placebo and lagundi tablets were acceptable as to taste and smell. Patient compliance with medications was comparable in the two treatment groups. Statistical analysis of the subjective and objective parameters showed no statistically significant difference in their clinical responses. A notable trend response however favored the lagundi group, with relief of expectoration and dyspnea in 87.5% of patients by the ninth day of lagundi therapy, compared with 66.7% of the placebo group. Peak respiratory flow rate values did not change significantly with either treatment. All 45 patients with acute cough of moderate severity completed the study. The profiles of patients in the two groups were comparable. Lagundi treatment resulted in a statistically significant increase in peak expiratory flow rate and a decrease in respiratory rate by the sixth day of administration, when compared with placebo. Based on clinical parameters, there was no significant difference in response to therapy in the two treatment groups, whether evaluated by patient or by physician at each visit.