ANTI-COUGH EFFECT OF LAGUNDI TABLET

5.2 PHASE II CLINICAL TRIAL

Open clinical evaluation of the safety and efficacy of Vitex negundo, L (Lagundi) tablet as anti-tussive agent

An open design phase II clinical trial was undertaken from January to December 1984 to determine the efficacy and safety of lagundi tablets as anti-tussive agent. The lagundi tablets were prepared by the NSTA-UPCP Pilot Plant from dried lagundi leaves (Batch No. 200583 CLSU-L). Patients were recruited from the Rosario Reyes Health Center and the Aurora Quezon Elementary School in San Andres, Malate, Manila. Patient’s criteria for inclusion included acute cough of at least 48 hours duration, age of 7 – 65 years and willingness to participate in the trial by signing an informed consent by the patient and/or the guardian ( for minors). Complete history and physical examination were conducted by the research team. Criteria for absolute exclusion included presence of heart, renal or hepatic disease, moderate to severe asthma, PTB, uncontrolled hypertension, pregnant and lactating women and drug intake for cough within 12 hours of consultation.

There were 25 patients evaluable, 14 females and 11 males. There were 19 children, 5 adults and one 16 years old. Bronchial asthma of mild severity was present in 4 patients and the rest (N-21) had upper respiratory, non-bacterial infection. Peak expiratory flow rates (3 trials) determined prior to drug administration. Directly observed drug intake for the first dose was done and hourly PEFR was determined. Dose for children 7-12 years was 1 tablet 3x daily and for >12 years and adults, dose administered was 2 tablets 3x daily. Improvement in cough frequency and PEFR was manifest by the 4th hour. Lagundi therapy was continued at home for up to 2 days. Parameters of efficacy were mainly based on relief of cough, ease of phlegm expectoration and lung findings. Complete relief, with disappearance of coughing was recorded in 52% (N-13) and partial relief of cough in 48% of patients. Baseline PEFR ranged from 180 – 410 L/min. with a mean value of 291 L/min. by the 4th hour, the PEFR mean value increased to 315.6 L/min 9 range of 180 – 420 L/min.) With improvement. After 2 days of lagundi therapy, the PEFR gave a mean value of 307.7 L/min with 5.7% increase compared with baseline. Of the 13 patients with complete cough relief, ten showed increased PEFR by the 4th hour, 2 had a decrease in PEFR and one showed no change. After 2 days of drug intake, there were 24 patients with PEFR values greater than their baseline while 5 patients showed decreased values. Of the 12 patients with partial relief of cough, 9 (75%) showed increased PEFR by the 4th hour post-drug intake and only 5 (42%) of them continued to have higher values than baseline after 2 days of therapy; 4 patients had decreased PEFR and 3 reverted to baseline values.

Evaluation of efficacy of lagundi for acute cough of mild severity showed complete or partial relief in all 25 patients. However, whereas there were more patients with complete cough relief who demonstrated improved PEFR values (74%) by the 4th hour post-dosing and after 2 days of treatment (61%) a few reverted to their baseline values or even had a decrease in PEFR (15%). It was also noted that significant clinical and pulmonary function improvement occurred 4 hours after lagundi intake.

No untoward effects were reported among the 25 patients and tablet acceptability and no difficulty in tablet swallowing were also reported.

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