Psychiatric DisorderNCT05219357
Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis Situations
A study testing Ayu-Care and Usual-Care in people with Psychiatric Disorder, run by Aarogyam UK at 2 sites in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- Ayu-Care and Usual-Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesIndia
- Study dates
- 21 Nov 2021to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who have delirium or dementia
- Prisoners
- Pediatric patients
- Elderly patients
- Pregnancy or breastfeeding
Trial locations and contacts
2 sites in 1 country.
India2 sites
Gyansanjeevani
Jaipur, Rajasthan
NMP Medical Research Institite
Jaipur, Rajasthan
About this study
Official title: Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis: Pilot Trial Using Community-Based Participatory Research
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.
- Conditions
- Psychiatric Disorder
- Being tested
- Ayu-Care, Usual-Care
- Keywords
- Ayurveda, Mental Health, Emergencies, Community Based Participatory Research
- Medical subject headings
- Mental Disorders, Psychological Well-Being, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ayu-CareOther
Also called Ayurveda
Ayurveda treatment modalities includes three parts to manage mental health Satwawajay Chikitsa, Yuktivyapashray and Daivyapashray Chikitsa. It is based on personalised whole person approach.
Usual-CareDrug
Management strategies includes restraints, emergency medications, behavioral interventions, with a special focus on the pharmacological interventions.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Group (UCG) | Active comparator | The usual care control group received care only on hospital wards during episodes Receives: Drug: Usual-Care |
| Ayu Care Group (ACG) | Other | Multidisciplinary Ayurveda based treatment team aimed to manage acute crises of patients in the community settings or at their home if feasible. Receives: Other: Ayu-Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Symptom Inventory
Brief Symptom Inventory was used to assess self-report of psychological problems and symptom severity
Measured: Change from baseline to 48 hours and 7th-days of intervention
Length of Emergency hospital stay
Length of stay is defined as the time between patient triage and discharge from the emergency department
Measured: Hours spent in the Emergency Department (ED), measured at the index ED visit (Day 0)
Secondary outcomes (7)
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.
Measured: Change from baseline to 3rd and 7th-days of intervention
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.
Measured: From Baseline to 3rd and 7th-days of intervention
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)
Measured: From Baseline to 48 hours and 7th-days of intervention
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)
Measured: From Baseline to 48 hours and 7th-days of intervention
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)
Measured: From Baseline to 3rd and 7th-days of intervention
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)
Measured: From Index ED visit to 30 days
Medication use
Daily doses and classes of medications (e.g. antipsychotics, mood stabilizers, benzodiazepines, etc.) or other treatments or interventions prescribed per individual
Measured: From Index ED visit to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start21 Nov 2021
- Primary completion30 Dec 2021
- Study completion30 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarogyam UK
- Sponsor type
- University, hospital or other
- Collaborators
- NMP Medical Research Institute, Croydon Ayurveda Centre, Active Naturals Limited, AVP Research Foundation
- Responsible party
- Sponsor
- Investigators
- Neha Sharma, Study director, Aarogyam (UK) CICVenkata N Joshi, Study chair, Croydon Ayurveda CentreMaël Voegeli, Principal investigator, AVP Research FoundationSkanthesh Lakshmanan, Study chair, NMP Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219357
- Sponsor's protocol ID
- NMP1873-92
- Status last verified
- Jan 2022
- First submitted
- 6 Jan 2022
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participants Data will not be available to other researchers. Data will only be shared through publications and presentations on study completion.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ayurveda Based Intervention for Patients in Acute Psychiatric Crisis: Pilot Trial Using Community-Based Participatory Research
- ClinicalTrials.gov ID
- NCT05219357
- Acronym / sponsor ID
- NMP1873-92
- Conditions
- Psychiatric Disorder
- Keywords
- Ayurveda, Mental Health, Emergencies, Community Based Participatory Research
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Aarogyam UKUniversity, hospital or other
- Collaborators
- NMP Medical Research Institute, Croydon Ayurveda Centre, Active Naturals Limited, AVP Research Foundation
- Study start
- 21 Nov 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Group (UCG) | Active comparator | Drug: Usual-CareThe usual care control group received care only on hospital wards during episodes |
| Ayu Care Group (ACG) | Other | Other: Ayu-CareMultidisciplinary Ayurveda based treatment team aimed to manage acute crises of patients in the community settings or at their home if feasible. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients who have delirium or dementia
- Prisoners
- Pediatric patients
- Elderly patients
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ayu-CareAlso: AyurvedaAyurveda treatment modalities includes three parts to manage mental health Satwawajay Chikitsa, Yuktivyapashray and Daivyapashray Chikitsa. It is based on personalised whole person approach. | Other | Ayu Care Group (ACG) |
| Usual-CareManagement strategies includes restraints, emergency medications, behavioral interventions, with a special focus on the pharmacological interventions. | Drug | Usual Care Group (UCG) |
Primary outcome
Brief Symptom Inventory
Time frame: Change from baseline to 48 hours and 7th-days of intervention
Brief Symptom Inventory was used to assess self-report of psychological problems and symptom severity
Length of Emergency hospital stay
Time frame: Hours spent in the Emergency Department (ED), measured at the index ED visit (Day 0)
Length of stay is defined as the time between patient triage and discharge from the emergency department
7 secondary outcomes
The Kessler Psychological Distress Scale (K10)
Time frame: Change from baseline to 3rd and 7th-days of intervention
The Psychological Outcome Profiles instrument
Time frame: From Baseline to 3rd and 7th-days of intervention
Agitation Calmness Evaluation Scale (ACES)
Time frame: From Baseline to 48 hours and 7th-days of intervention
Positive and Negative Syndrome Scale;
Time frame: From Baseline to 48 hours and 7th-days of intervention
Satisfaction with acute care
Time frame: From Baseline to 3rd and 7th-days of intervention
Side effects
Time frame: From Index ED visit to 30 days
Medication use
Time frame: From Index ED visit to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No. Individual Participants Data will not be available to other researchers. Data will only be shared through publications and presentations on study completion.
Related trials for Psychiatric Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Sharma study director
Aarogyam (UK) CIC
Venkata N Joshi study chair
Croydon Ayurveda Centre
Maël Voegeli principal investigator
AVP Research Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ayu-Care and Usual-Care in people with Psychiatric Disorder, run by Aarogyam UK at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Symptom Inventory (time frame: Change from baseline to 48 hours and 7th-days of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.