VEDADiet and Lifestyle Modification in Mothers With Burnout-Syndrome: Ayurvedic Versus Conventional Standard Counseling - A Randomized Controlled Clinical Pilot Study
Diet and Lifestyle Counseling
+ Diet and Lifestyle Counseling
Behavior+1
+ Behavioral Symptoms
+ Stress, Psychological
Supportive Care Study
Summary
Study start date: May 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location