A Safety and Efficacy Study of Bacopa Monnieri and Nardostachys Jatamansi to Treat Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a herbal combination of water based
      extracts of Bacopa monnieri(BM) and Nardostachys jatamansi(NJ) is effective in the treatment
      of Schizophrenia.

      The working hypothesis for this study is that a herbal combination of BM and NJ will be as
      effective as modern anti-psychotic drugs, in the treatment of Schizophrenia, and will be safe
      for long term use.
    

Detailed description: 
      At present, there is no clearly effective treatment of Schizophrenia, which is present in 1%
      of the population. While acute psychotic episodes are well-controlled with modern medicines,
      long-term prognosis in terms of quality of life and productivity remain poor. In India, more
      than 50% of beds in mental hospitals is taken up by Schizophrenic patients, without much of
      cost-benefit outcome.In clinical practice, Ayurvedic treatment has proved to be effective and
      well-accepted in patients of Schizophrenia, is safe on long-term use, and may bring about the
      desired long-term positive changes in patient-health outcome.

      In this proposed project, 200 patients of Schizophrenia will be recruited from the local and
      regional psychiatric institutions. The patients will be in the age group from 18-60 and of
      either sex. Patients suffering from any organic disorder will not be included in the study.
      Patients having any concomitant drug addiction will also not be included. Each patient and a
      close relative (as guardian) will be required to sign a consent form, for the clinical trial,
      in the regional language. Full, written information about the proposed clinical trial will be
      given to the patient and relatives. All information will be available in English and two
      regional languages, viz. Hindi and Marathi. Full detailed history and clinical examination of
      all patients will be done. Each patient will be interviewed with the Structured Clinical
      Interview for Axis I DSM-IV Disorders (SCID).Diagnosis of Schizophrenia will be done using
      the DSM-IV-TR diagnostic criteria for Schizophrenia (from American Psychiatric Association:-
      Diagnostic and Statistical Manual of Mental Disorders - 2000). This will also include
      classification of longitudinal course in patients having more than 1 year's duration of onset
      of active-phase symptoms. The clinical profile of each patient will be evaluated using the
      Positive and Negative Symptom scale for Schizophrenia. This is a structured clinical
      interview (SCI-PANSS) having 30 items which rate along a seven point continuum (1 = absent; 7
      = extreme severe). The assessment provides separate scores in nine clinical domains including
      a positive syndrome, a negative syndrome, depression, a composite index, and general
      psychopathology. The SCI-PANSS will be used for each patient initially for baseline
      evaluation before commencing treatment and later, once in 3 months, to provide assessment of
      treatment response. The patients will be divided at random into 2 groups of 100 each, one a
      study group and the other a control group. A brief wash-out period of 2 weeks will be given
      to patients already taking some medication. The study group will be given Ayurvedic medicine
      in the dose of 2 tablets b.i.d. of BM, and 1tablet b.i.d. of NJ; with each 350 mg. tablet
      containing 200mg of aqueous extract . This dosage is in accordance with prevalent use of the
      above two herbs, in adults. The control group will be given a standard anti-psychotic drug
      Olanzapine, 10 mg. o.d.

      Patients will be dispensed Ayurvedic medicine or anti-psychotic for 4 weeks and then
      reassessed at every visit. Basic clinical examination and clinical changes will be noted.
      Baseline SGPT/B. Urea/ S. Creatinine will be done for all patients and repeated every 6
      months, to assess any possible drug toxicity. The progress of the patients will be carefully
      monitored for a total period of 78 weeks each, with a watch for any possible signs of drugs
      toxicity, treatment failure or aggravation of symptoms.
    

Intervention name(s): Bacopa monnieri; Nardostachys jatamansi; Olanzapine
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Herbal extracts; Randomized; Controlled; Clinical Trial