(J. Comm. Psychiatry (1989): (12), 2-4, 15-16) 

Dr. Sudipto Das
Dept. of Psychiatry, J.J. Hospital and Grant Medical College, Bombay, India.
and
Dr. Alan De Sousa
Head of the Department of Psychiatry & Hon. Professor of Psychiatry,
Grant Medical College & J.J. Hospital, Bombay, India.
Visiting Professor, Department of Applied Psychology, University of Bombay, Bombay, India. 

BR-16, an indigenous Ayurvedic preparation had been found by previous research to have a marked effect on the Sympathetic Nervous System. In addition, it was seen to reduce nervousness, irritability, to improve memory, have sedative properties and to enhance concentration.

The drug had been used extensively with children, having a variety of behavioural problems, particularly those having Minimal Brain Damage and it was found to be useful and safe. Accordingly, it would be considered that his drug may prove useful in treating Schizophrenia and thus the trial was planned. 

Twenty patients (14 males, 6 females) aged 18 to 60 years, who fulfilled the criteria for Chronic Undifferentiated Schizophrenia laid down in D.S.M. - III -R, were taken up randomly for this study after the diagnosis was confirmed by two senior Psychiatrists who saw the patients independently. Patients with many relapses and particularly those showing evidence of ‘negative’ symptoms were selected. No patient suffering from any organic disorder was included in this study. The patients had an initial wash-out period of three weeks if they were already taking any medication. The patients were assessed on the Rockland’s Rating Scale for Psychotics and the Andreasen’s Rating Scale of Negative Symptoms. 

They were then administered BR-16 in the dose of 2 tablets three times a day in week 1, followed by 3 tablets three times a day in weeks 2 to 8. 

Reassessment of the patients was done on both the scales every week to note the progress. The patients were investigated physically and biochemically prior to the administration of medication and after the completion of the trial (i.e. after 8 weeks) for any changes. The side-effects of the drug were noted. The results of the study were analysed. 

1. Number of patients : 20

2. Sex : Males - 14; Females - 6.

3. Age : 18 to 30 years : 5
31 to 40 years : 1 3
41 to 60 years : 2 

Before treatment -23

Week 1 -19

Week 2 -12

Week 3 - 9

Week 4 - 8

Week 5 - 6

Week 6 - 6

Week 7 - 4

Week 8 - 4 

Before treatment +77

Week 1 +71

Week 2 +64

Week 3 +61

Week 4 +55

Week 5 +50

Week 6 +42

Week 7 +39

Week 8 +37 

Dryness of mouth : 4
Constipation : 2
Mild E.P.R. : 2 

Liver Function Test : No change
Blood Urea : No change
Serum Creatinine : No change.

The results of this small trial of BR-16 in Chronic Schizophrenia speaks positively about its utility. Patients improved both clinically and on the scores on the two Rating Scales considerably. 

The symptoms that particularly improved were emotional exteriorization, quantum of speech, motility, fund of energy and general outlook on life. 

This study needs to be replicated and perhaps a double blind study would be particularly useful to elicit the real utility of BR-16 in the management of particularly the negative symptoms of Schizophrenia. We are now proceeding with such a study. Until the results of this study are available we can only remark that BR-16 is both useful and safe and worth a trial in Schizophrenia.