A Safety and Efficacy Study of Bacopa Monnieri and Nardostachys Jatamansi to Treat Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Bacopa monnieri
Nardostachys jatamansi
Olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Herbal extracts, Randomized, Controlled, Clinical Trial
Eligibility 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.
Sites / Locations
- Q.Mundewadi Ayurvedic Research & Charitable Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
The group getting the study drugs, Bacopa monnieri and Nardostachys jatamansi
The group getting Olanzapine
Outcomes
Primary Outcome Measures
The change in the total PANSS score from baseline till the end of the study.
Secondary Outcome Measures
The change in physical , clinical , and hematological parameters from baseline till the end of 78 weeks of treatment
Full Information
NCT ID
NCT00483964
First Posted
June 6, 2007
Last Updated
October 9, 2007
Sponsor
Q.Mundewadi Ayurvedic Research & Charitable Trust
Collaborators
Stanley Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00483964
Brief Title
A Safety and Efficacy Study of Bacopa Monnieri and Nardostachys Jatamansi to Treat Schizophrenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Q.Mundewadi Ayurvedic Research & Charitable Trust
Collaborators
Stanley Medical Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Herbal extracts, Randomized, Controlled, Clinical Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
The group getting the study drugs, Bacopa monnieri and Nardostachys jatamansi
Arm Title
B
Arm Type
Active Comparator
Arm Description
The group getting Olanzapine
Intervention Type
Drug
Intervention Name(s)
Bacopa monnieri
Intervention Type
Drug
Intervention Name(s)
Nardostachys jatamansi
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Primary Outcome Measure Information:
Title
The change in the total PANSS score from baseline till the end of the study.
Time Frame
78 weeks
Secondary Outcome Measure Information:
Title
The change in physical , clinical , and hematological parameters from baseline till the end of 78 weeks of treatment
Time Frame
78 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbdulMubeen A Mundewadi, B.A.M.S.
Organizational Affiliation
Q.Mundewadi Ayurvedic Research & Charitable Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Q.Mundewadi Ayurvedic Research & Charitable Trust
City
Mumbra,Thane
State/Province
Maharashtra
ZIP/Postal Code
400612
Country
India
12. IPD Sharing Statement
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A Safety and Efficacy Study of Bacopa Monnieri and Nardostachys Jatamansi to Treat Schizophrenia
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