A Safety and Efficacy Study of Bacopa Monnieri and Nardostachys Jatamansi to Treat Schizophrenia

A Randomized, Controlled ,Clinical Trial of a Herbal Combination of Aqueous Extracts of Bacopa Monnieri and Nardostachys Jatamansi in the Treatment of Schizophrenia, Compared to Standard Anti-Psychotic Drugs

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Olanzapine; Drug: Bacopa monnieri; Drug: Nardostachys jatamansi

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbra,Thane, Maharashtra, India, 400612
      • Q.Mundewadi Ayurvedic Research & Charitable Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any sex
• Age 18 - 60 years
• History suggestive of Schizophrenia using the DSM-IV-TR diagnostic criteria.
• Presence of a caretaker/legal guardian who would take the responsibility of giving regular medication and bringing the patient for regular follow-ups.

Exclusion Criteria:

• Age< 18 or > 60 years
• Known history of drug addiction
• Known medical history which may cause similar symptoms e.g. Schizoaffective /Mood Disorders, Pervasive Developmental Disorder
• History of severe or repeated episodes of violence.
• History of any other concurrent illness which could interfere in the treatment and assessment of the subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; The group getting the study drugs, Bacopa monnieri and Nardostachys jatamansi	Drug: Bacopa monnieri; Drug: Nardostachys jatamansi
Active Comparator: B; The group getting Olanzapine	Drug: Olanzapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change in the total PANSS score from baseline till the end of the study.	78 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
The change in physical , clinical , and hematological parameters from baseline till the end of 78 weeks of treatment	78 weeks

Collaborators and Investigators

• Sponsor: Q.Mundewadi Ayurvedic Research & Charitable Trust
• Collaborators: Stanley Medical Research Institute
• Investigators: Principal Investigator: AbdulMubeen A Mundewadi, B.A.M.S., Q.Mundewadi Ayurvedic Research & Charitable Trust

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Study Completion (Actual): September 1, 2007

Study Registration Dates

• First Submitted: June 6, 2007
• First Submitted That Met QC Criteria: June 6, 2007
• First Posted (Estimate): June 8, 2007

Study Record Updates

• Last Update Posted (Estimate): October 10, 2007
• Last Update Submitted That Met QC Criteria: October 9, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: Schizophrenia; Randomized; Clinical Trial; Controlled; Herbal extracts
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: SMRI #04T-512