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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05219357
Other study ID # NMP1873-92
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 21, 2021
Est. completion date January 30, 2022

Study information

Verified date January 2022
Source Aarogyam UK
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 92
Est. completion date January 30, 2022
Est. primary completion date December 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
Drug:
Usual-Care
Management strategies includes restraints, emergency medications, behavioral interventions, with a special focus on the pharmacological interventions.

Locations

Country Name City State
India Gyansanjeevani Jaipur Rajasthan
India NMP Medical Research Institite Jaipur Rajasthan

Sponsors (5)

Lead Sponsor Collaborator
Aarogyam UK Active Naturals Limited, AVP Research Foundation, Croydon Ayurveda Centre, NMP Medical Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Other Death by Suicide Death by suicide within 30 days of the index ED visit From Index ED visit to 30 days
Primary Brief Symptom Inventory Brief Symptom Inventory was used to assess self-report of psychological problems and symptom severity Change from baseline to 48 hours and 7th-days of intervention
Primary Length of Emergency hospital stay Length of stay is defined as the time between patient triage and discharge from the emergency department Hours spent in the Emergency Department (ED), measured at the index ED visit (Day 0)
Secondary The Kessler Psychological Distress Scale (K10) The K10 comprises 10 items that rate symptoms along the anxiety-depression spectrum, with a five point Likert response, where one is 'none of the time' to five 'all of the time. Change from baseline to 3rd and 7th-days of intervention
Secondary The Psychological Outcome Profiles instrument To measure participant-generated outcomes comprising four items on 6 scale (0-5) 0 = not at all affected' to '5 = severely affected. From Baseline to 3rd and 7th-days of intervention
Secondary Agitation Calmness Evaluation Scale (ACES) The ACES consists of a single item that rates overall agitation at the time of patients observations on 9 scale (1=marked agitation, 4=normal behaviour, 9= unarousable) From Baseline to 48 hours and 7th-days of intervention
Secondary Positive and Negative Syndrome Scale; The tool consists of 5 items: excitement, tension, hostility, being uncooperative, and poor impulse control. Each item is scored on 7-point scale (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, and 7=extreme) From Baseline to 48 hours and 7th-days of intervention
Secondary Satisfaction with acute care Measured on 5-point scale, completed by the participant using the Service Satisfaction Scale 10 (SSS-10), from 1 (No, definitely not) to five (Yes, definitely) From Baseline to 3rd and 7th-days of intervention
Secondary Side effects The frequency of any side effects or adverse events experienced by individuals to both intervention group on 4 point scale (landing from absent=0 to severe=3) From Index ED visit to 30 days
Secondary Medication use Daily doses and classes of medications (e.g. antipsychotics, mood stabilizers, benzodiazepines, etc.) or other treatments or interventions prescribed per individual From Index ED visit to 30 days
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