NCT00483964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2 schizophrenia

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

October 10, 2007

Status Verified

October 1, 2007

First QC Date

June 6, 2007

Last Update Submit

October 9, 2007

Conditions

Schizophrenia

Keywords

SchizophreniaHerbal extractsRandomizedControlledClinical Trial

Outcome Measures

Primary Outcomes (1)

  • The change in the total PANSS score from baseline till the end of the study.

    78 weeks

Secondary Outcomes (1)

  • The change in physical , clinical , and hematological parameters from baseline till the end of 78 weeks of treatment

    78 weeks

Study Arms (2)

A

EXPERIMENTAL

The group getting the study drugs, Bacopa monnieri and Nardostachys jatamansi

Drug: Bacopa monnieriDrug: Nardostachys jatamansi

B

ACTIVE COMPARATOR

The group getting Olanzapine

Drug: Olanzapine

Interventions

Bacopa monnieriDRUG
A
Nardostachys jatamansiDRUG
A
OlanzapineDRUG
B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Q.Mundewadi Ayurvedic Research & Charitable Trust

Mumbra,Thane, Maharashtra, 400612, India

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Valeriana extractOlanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • AbdulMubeen A Mundewadi, B.A.M.S.

    Q.Mundewadi Ayurvedic Research & Charitable Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 6, 2007

First Posted

June 8, 2007

Study Start

September 1, 2005

Study Completion

September 1, 2007

Last Updated

October 10, 2007

Record last verified: 2007-10

Locations

IN(1)