Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis Situations

NCT ID: NCT05219357

Last Updated: 2022-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-21

Study Completion Date

2022-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

For patients undergoing a psychiatric crisis, hospitalisation is required. In developing countries specially in sub-urban or rural areas, most patients don't access intensive care. In India, AYUSH system of medical care is widely used, including crisis resolution and community treatment have been widely implemented in various mental health systems. However, evidence to support their effectiveness has remained very low.

Present study is designed as community based participatory research, where Ayurveda treatment , a short-term, specialised, crisis intervention is provided by community outreach team.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psychiatric Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual Care Group (UCG)

The usual care control group received care only on hospital wards during episodes

Group Type ACTIVE_COMPARATOR

Usual-Care

Intervention Type DRUG

Management strategies includes restraints, emergency medications, behavioral interventions, with a special focus on the pharmacological interventions.

Ayu Care Group (ACG)

Multidisciplinary Ayurveda based treatment team aimed to manage acute crises of patients in the community settings or at their home if feasible.

Group Type OTHER

Ayu-Care

Intervention Type OTHER

Ayurveda treatment modalities includes three parts to manage mental health Satwawajay Chikitsa, Yuktivyapashray and Daivyapashray Chikitsa. It is based on personalised whole person approach.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ayu-Care

Ayurveda treatment modalities includes three parts to manage mental health Satwawajay Chikitsa, Yuktivyapashray and Daivyapashray Chikitsa. It is based on personalised whole person approach.

Intervention Type OTHER

Usual-Care

Management strategies includes restraints, emergency medications, behavioral interventions, with a special focus on the pharmacological interventions.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ayurveda

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Presenting with a psychiatric complaint.
* Male or female patients at least 18 years of age.
* Each patient, or a patient's legal representative (as allowed by local law), must understand the nature of the study and must agree to study enrollment.

Exclusion Criteria

* Patients who have delirium or dementia
* Prisoners
* Pediatric patients
* Elderly patients
* Pregnancy or breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NMP Medical Research Institute

OTHER

Sponsor Role collaborator

Croydon Ayurveda Centre

UNKNOWN

Sponsor Role collaborator

Active Naturals Limited

UNKNOWN

Sponsor Role collaborator

AVP Research Foundation

UNKNOWN

Sponsor Role collaborator

Aarogyam UK

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Neha Sharma

Role: STUDY_DIRECTOR

Aarogyam (UK) CIC

Venkata N Joshi

Role: STUDY_CHAIR

Croydon Ayurveda Centre

Maƫl Voegeli

Role: PRINCIPAL_INVESTIGATOR

AVP Research Foundation

Skanthesh Lakshmanan

Role: STUDY_CHAIR

NMP Medical Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gyansanjeevani

Jaipur, Rajasthan, India

Site Status

NMP Medical Research Institite

Jaipur, Rajasthan, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NMP1873-92

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bringing Health Home
NCT05160701 ACTIVE_NOT_RECRUITING NA
Testing the Efficacy of ACT for Life
NCT04829682 ENROLLING_BY_INVITATION NA
Women's Wellbeing Study
NCT07195019 RECRUITING NA