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Ayurvedic Nutritional Counseling for Patients With IBS in Comparison to Conventional Nutritional Counseling (AYURDA)

Primary Purpose

IBS - Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Ayurvedic nutritional counseling
Conventional nutritional counseling
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IBS - Irritable Bowel Syndrome focused on measuring Ayurveda, IBS, Complementary medicine, nutritional counseling

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis "irritable bowel syndrome" according to the ROM-III criteria and the German S3 guideline (Layer 2011)
  • Female and male patients between 18 and 70 years of age
  • Declaration of consent

Exclusion Criteria:

  • Bad general condition
  • Serious acute or chronic comorbidity
  • Pregnancy and breast feeding period
  • Eating disorder
  • In recognition procedures for early retirement or disability
  • Simultaneous participation in another clinical trial
  • Participation in a clinical trial within the last 3 months before enrollment

Sites / Locations

  • Kliniken Essen-Mitte
  • Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ayurvedic nutritional counseling

Conventional nutritional counseling

Arm Description

Patients will receive three Ayurvedic nutritional counselings (according to tradition) after 1, 3 and 8 weeks after Baseline.

Patients will receive three conventional nutritional counselings (according to German Nutrition Society - DGE) after 1, 3 and 8 weeks after Baseline.

Outcomes

Primary Outcome Measures

Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change

Secondary Outcome Measures

Cohen Perceived Stress Scale (CPSS) - Change
Hospital Anxiety and Depression Scale (HADS-D) - Change
Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change
VAS: Pain, Sleep, General bothersomeness, Expectation - Change
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change

Full Information

First Posted
January 2, 2017
Last Updated
August 2, 2021
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03019861
Brief Title
Ayurvedic Nutritional Counseling for Patients With IBS in Comparison to Conventional Nutritional Counseling
Acronym
AYURDA
Official Title
Randomized Controlled Study on Ayurvedic Nutritional Counseling for Patients With Irritable Bowel Syndrome in Comparison to Conventional Nutritional Counseling
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

5. Study Description

Brief Summary
The main goal of this randomized controlled clinical study is to evaluate the efficacy of an individual Ayurvedic nutritional counseling (according to tradition) compared to an individual conventional dietary advice (according to the German Nutrition Society - DGE) in patients with irritable bowel syndrome. It is to be investigated whether nutritional therapy elements, which patients can self-implement independently in the home environment, can achieve sustainable therapy effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome
Keywords
Ayurveda, IBS, Complementary medicine, nutritional counseling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ayurvedic nutritional counseling
Arm Type
Active Comparator
Arm Description
Patients will receive three Ayurvedic nutritional counselings (according to tradition) after 1, 3 and 8 weeks after Baseline.
Arm Title
Conventional nutritional counseling
Arm Type
Active Comparator
Arm Description
Patients will receive three conventional nutritional counselings (according to German Nutrition Society - DGE) after 1, 3 and 8 weeks after Baseline.
Intervention Type
Behavioral
Intervention Name(s)
Ayurvedic nutritional counseling
Intervention Type
Behavioral
Intervention Name(s)
Conventional nutritional counseling
Primary Outcome Measure Information:
Title
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
Time Frame
Change from IBS-SSS Baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Cohen Perceived Stress Scale (CPSS) - Change
Time Frame
Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months
Title
Hospital Anxiety and Depression Scale (HADS-D) - Change
Time Frame
Change from HADS-D Baseline at 4 weeks, 12 weeks and 6 months
Title
Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change
Time Frame
Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months
Title
VAS: Pain, Sleep, General bothersomeness, Expectation - Change
Time Frame
Change from VAS Baseline at 4 weeks, 12 weeks and 6 months
Title
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
Time Frame
Change from IBS-SSS Baseline at 4 weeks and 6 months
Other Pre-specified Outcome Measures:
Title
Stool analysis: Intestinal microbiome by sequencing 16S rRNA
Time Frame
Baseline, 4 weeks
Title
Qualitative interviews in focus groups
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis "irritable bowel syndrome" according to the ROM-III criteria and the German S3 guideline (Layer 2011) Female and male patients between 18 and 70 years of age Declaration of consent Exclusion Criteria: Bad general condition Serious acute or chronic comorbidity Pregnancy and breast feeding period Eating disorder In recognition procedures for early retirement or disability Simultaneous participation in another clinical trial Participation in a clinical trial within the last 3 months before enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Michalsen, Prof. Dr.
Organizational Affiliation
Charité University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kliniken Essen-Mitte
City
Essen
State/Province
Am Deimelsberg 34 A
ZIP/Postal Code
45276
Country
Germany
Facility Name
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
City
Berlin
ZIP/Postal Code
14109
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34552937
Citation
Jeitler M, Wottke T, Schumann D, Puerto Valencia LM, Michalsen A, Steckhan N, Mittwede M, Stapelfeldt E, Koppold-Liebscher D, Cramer H, Wischnewsky M, Murthy V, Kessler CS. Ayurvedic vs. Conventional Nutritional Therapy Including Low-FODMAP Diet for Patients With Irritable Bowel Syndrome-A Randomized Controlled Trial. Front Med (Lausanne). 2021 Sep 6;8:622029. doi: 10.3389/fmed.2021.622029. eCollection 2021.
Results Reference
derived

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Ayurvedic Nutritional Counseling for Patients With IBS in Comparison to Conventional Nutritional Counseling

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