MedDataX Logo

Ayurvedic Versus Conventional Counseling in Mothers With Burnout-Syndrome

NCT ID: NCT01797887

Last Updated: 2014-12-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-12-31

Brief Summary

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

Aim of this study is to evaluate the effectiveness of Ayurvedic diet and lifestyle counseling compared to conventional standard diet and lifestyle counseling in outpatient mothers with burnout-syndrome.

Detailed Description

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

Ayurveda is a traditional Indian medicine: as a whole medical system it consists of diagnostic procedures and complex treatments. Ayurveda-treatment is based on Ayurvedic diagnosis and has a special focus on lifestyle and nutritional counseling, based on the individual constitution of the patient. Ayurvedic counseling can easily be followed by the patients in their day-to-day life and is an inexpensive way of self-care. In Ayurveda it is often used for the treatment of burnout-syndrome. However, no systematic data is available on its effectiveness in comparison to conventional standard diet and lifestyle counseling. The aim of this study is to evaluate the effectiveness of Ayurvedic diet and lifestyle counseling compared to conventional standard diet and lifestyle counseling in outpatient mothers with burnout-syndrome.

Conditions

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

Burnout-Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Burnout-Syndrome Ayurveda Ayurvedic Traditional Indian Medicine CAM Whole Medical System Diet and Lifestyle Counseling

Study Design

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

Allocation Method

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.

Ayurveda

Ayurveda Diet and Lifestyle Counseling

Group Type EXPERIMENTAL

Diet and Lifestyle Counseling

Intervention Type BEHAVIORAL

Diet and Lifestyle Counseling

Conventional

Standard Conventional Diet and Lifestyle Counseling

Group Type ACTIVE_COMPARATOR

Diet and Lifestyle Counseling

Intervention Type BEHAVIORAL

Diet and Lifestyle Counseling

Interventions

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

Diet and Lifestyle Counseling

Diet and Lifestyle Counseling

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

* signed informed consent
* age between 18 and 50
* mother of ≥ 1 child ≤ 12 years of age
* job, education or studies ≥ 20 hours per week
* subjective feeling of physical and mental exhaustion since ≥ 3 month
* ≥ 18 points in the MBI Subscale "emotional exhaustion" at screening

Exclusion Criteria

* change of psychotropic drug medication ≤ 6 weeks before inclusion
* pregnancy or breastfeeding
* pre-diagnosed major depression
* serious chronic co-morbidity (e.g. CHF NYHA IV)
* serious acute somatic health conditions
* intake of opiods
* simultaneous participation in other trials
* praticipation in other trials during ≤ 6 month before inclusion
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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

Karl and Veronica Carstens Foundation

OTHER

Sponsor Role collaborator

European Association for Ayurveda Therapists, Germany (VEAT)

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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

Andreas Michalsen

Prof. Dr. med. Andreas Michalsen

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Andreas Michalsen, MD

Role: PRINCIPAL_INVESTIGATOR

Charité Medical University Berlin, Germany

Locations

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

Immanuel Hospital Berlin

Berlin, State of Berlin, Germany

Site Status

Countries

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

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Kessler CS, Eisenmann C, Oberzaucher F, Forster M, Steckhan N, Meier L, Stapelfeldt E, Michalsen A, Jeitler M. Ayurvedic versus conventional dietary and lifestyle counseling for mothers with burnout-syndrome: A randomized controlled pilot study including a qualitative evaluation. Complement Ther Med. 2017 Oct;34:57-65. doi: 10.1016/j.ctim.2017.07.005. Epub 2017 Jul 16.

Reference Type DERIVED
PMID: 28917376 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.naturheilkunde.immanuel.de

Immanuel Hospital Berlin, Germany

http://www.charite.de

Cahrité Medical University Berlin, Germany

Other Identifiers

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

VEDA-Trial

Identifier Type: -

Identifier Source: org_study_id