IBS - Irritable Bowel SyndromeAYURDANCT03019861
Ayurvedic Nutritional Counseling for Patients With IBS in Comparison to Conventional Nutritional Counseling
A study testing Ayurvedic nutritional counseling and Conventional nutritional counseling in people with IBS - Irritable Bowel Syndrome, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Ayurvedic nutritional counseling and Conventional nutritional counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2017to Feb 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, 14109
Kliniken Essen-Mitte
Essen, Am Deimelsberg 34 A, 45276
About this study
Official title: Randomized Controlled Study on Ayurvedic Nutritional Counseling for Patients With Irritable Bowel Syndrome in Comparison to Conventional Nutritional Counseling
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.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Ayurvedic nutritional counseling, Conventional nutritional counseling
- Keywords
- Ayurveda, IBS, Complementary medicine, nutritional counseling
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ayurvedic nutritional counselingBehavioural
Conventional nutritional counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Ayurvedic nutritional counseling | Active comparator | Patients will receive three Ayurvedic nutritional counselings (according to tradition) after 1, 3 and 8 weeks after Baseline. Receives: Behavioral: Ayurvedic nutritional counseling |
| Conventional nutritional counseling | Active comparator | Patients will receive three conventional nutritional counselings (according to German Nutrition Society - DGE) after 1, 3 and 8 weeks after Baseline. Receives: Behavioral: Conventional nutritional counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
Measured: Change from IBS-SSS Baseline at 12 weeks
Secondary outcomes (5)
Cohen Perceived Stress Scale (CPSS) - Change
Measured: Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months
Hospital Anxiety and Depression Scale (HADS-D) - Change
Measured: Change from HADS-D Baseline at 4 weeks, 12 weeks and 6 months
Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change
Measured: Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months
VAS: Pain, Sleep, General bothersomeness, Expectation - Change
Measured: Change from VAS Baseline at 4 weeks, 12 weeks and 6 months
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
Measured: Change from IBS-SSS Baseline at 4 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionOct 2018
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
- Investigators
- Andreas Michalsen, Prof. Dr., Principal investigator, Charité University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019861
- Sponsor's protocol ID
- AYURDA
- Acronym
- AYURDA
- Status last verified
- Aug 2021
- First submitted
- 2 Jan 2017
- Last updated
- 6 Aug 2021
- Results posted
- No
Publications
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.
PubMed 34552937
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study on Ayurvedic Nutritional Counseling for Patients With Irritable Bowel Syndrome in Comparison to Conventional Nutritional Counseling
- ClinicalTrials.gov ID
- NCT03019861
- Acronym / sponsor ID
- AYURDA / AYURDA
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- Ayurveda, IBS, Complementary medicine, nutritional counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 13 Jan 2017 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ayurvedic nutritional counseling | Active comparator | Behavioral: Ayurvedic nutritional counselingPatients will receive three Ayurvedic nutritional counselings (according to tradition) after 1, 3 and 8 weeks after Baseline. |
| Conventional nutritional counseling | Active comparator | Behavioral: Conventional nutritional counselingPatients will receive three conventional nutritional counselings (according to German Nutrition Society - DGE) after 1, 3 and 8 weeks after Baseline. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Bad general condition
- Serious acute or chronic comorbidity
- Pregnancy and breast feeding period
- Eating disorder
- In recognition procedures for early retirement or disability
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 |
|---|---|---|
| Ayurvedic nutritional counseling | Behavioural | Ayurvedic nutritional counseling |
| Conventional nutritional counseling | Behavioural | Conventional nutritional counseling |
Primary outcome
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
Time frame: Change from IBS-SSS Baseline at 12 weeks
5 secondary outcomes
Cohen Perceived Stress Scale (CPSS) - Change
Time frame: Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months
Hospital Anxiety and Depression Scale (HADS-D) - Change
Time frame: Change from HADS-D Baseline at 4 weeks, 12 weeks and 6 months
Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change
Time frame: Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months
VAS: Pain, Sleep, General bothersomeness, Expectation - Change
Time frame: Change from VAS Baseline at 4 weeks, 12 weeks and 6 months
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change
Time frame: Change from IBS-SSS Baseline at 4 weeks and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Derived from this study: PubMed 34552937Jeitler 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.
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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.
Andreas Michalsen, Prof. Dr. principal investigator
Charité University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ayurvedic nutritional counseling and Conventional nutritional counseling in people with IBS - Irritable Bowel Syndrome, run by Charite University, Berlin, Germany at 2 sites in Germany.
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 7 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: finished, as of the sponsor's last update on 6 Aug 2021. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change (time frame: Change from IBS-SSS Baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03019861, which also lists 1 linked publication.
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 6 Aug 2021.