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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00483964
First Posted: June 8, 2007
Last Update Posted: October 10, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stanley Medical Research Institute
Information provided by:
Q.Mundewadi Ayurvedic Research & Charitable Trust
  Purpose

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.


Condition Intervention Phase
Schizophrenia Drug: Bacopa monnieri Drug: Nardostachys jatamansi Drug: Olanzapine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Q.Mundewadi Ayurvedic Research & Charitable Trust:

Primary Outcome Measures:
  • The change in the total PANSS score from baseline till the end of the study. [ Time Frame: 78 weeks ]

Secondary Outcome Measures:
  • The change in physical , clinical , and hematological parameters from baseline till the end of 78 weeks of treatment [ Time Frame: 78 weeks ]

Enrollment: 200
Study Start Date: September 2005
Study Completion Date: September 2007
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483964


Locations
India
Q.Mundewadi Ayurvedic Research & Charitable Trust
Mumbra,Thane, Maharashtra, India, 400612
Sponsors and Collaborators
Q.Mundewadi Ayurvedic Research & Charitable Trust
Stanley Medical Research Institute
Investigators
Principal Investigator: AbdulMubeen A Mundewadi, B.A.M.S. Q.Mundewadi Ayurvedic Research & Charitable Trust
  More Information

ClinicalTrials.gov Identifier: NCT00483964     History of Changes
Other Study ID Numbers: SMRI #04T-512
First Submitted: June 6, 2007
First Posted: June 8, 2007
Last Update Posted: October 10, 2007
Last Verified: October 2007

Keywords provided by Q.Mundewadi Ayurvedic Research & Charitable Trust:
Schizophrenia
Herbal extracts
Randomized
Controlled
Clinical Trial

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents