To Analyze TCM Syndrome and Symptoms of FGIDs PatientsNCT04225559
Analysis of Gastrointestinal Symptoms of Outpatients With Functional Gastrointestinal Diseases（FGIDs） in Grade-A Tertiary Hospitals in China
An observational study of To Analyze TCM Syndrome and Symptoms of FGIDs Patients, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 16 sites in China.
Trial summary
To analyze the classification characteristics of gastrointestinal symptoms, the quality of life, the degree of anxiety and depression, and the satisfaction with the treatment of Chinese medicine in patients with FGIDs in Chinese Grade-A Tertiary Hospitals. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- To Analyze TCM Syndrome and Symptoms of FGIDs Patients
- How many people
- 4,632 participants
- Where
- 16 sitesChina
- Study dates
- 1 Nov 2019to 31 Dec 2021
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients in Chinese Grade-A tertiary hospitals who has been diagnosed FGIDs
Who may be able to join
- Symptoms has appeared for at least 3 months;
- No organic disease and gastrointestinal alarm symptoms, which meet the diagnostic criteria of FGIDs;
- Sign informed consent and be able to read and understand the questionnaire.
Who cannot join
- A history of organic gastrointestinal diseases;
- Alarm symptoms of digestive tract (such as melena, weight loss, fever, abdominal mass, ascites, anemia, family history of gastrointestinal tumors, etc.)
- Have a history of mental diseases;
- Unable to read and understand the questionnaire.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
Xiyuan hospital
Beijing, Beijing Municipality, 100029
Fengyun Wang, MD, 010-86-62835610, wfy811@163.com
- Recruiting
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Dongcheng, Beijing Municipality, 100010
Hongbing Wang
- Recruiting
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510006
Shaogang Huang
- Recruiting
Inner Mongolia Autonomous Region Hospital Chinese Medicne
Hohhot, Inner Mongolia
yuxia wei
- Recruiting
Hong Kong Chinese Medicine Clinical Study Centre
Hong Kong
Lidan Zhong
- Recruiting
School of Chinese Medicine,Hong Kong Baptist University
Hong Kong
Lidan Zhong
- Recruiting
Liuzhou Traditional Chinese Medical Hospital
Liuzhou, Guangxi
Xiaoling Zhou
- Recruiting
Jiangsu Provincial Hospital of Chinese Medicine
Nanjing, Jiangsu
Bai Ye
- Recruiting
Institute of Digestive Diseases, Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
Jianye Yuan
- Recruiting
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,
Shenyang, Liaoning
Guang Bai
- Recruiting
Shanxi Provincial Hospital Of Traditional Chinese Medicine
Taiyuan, Shanxi
Juanping Su
- Recruiting
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality
Zhenghua Zhou
- Recruiting
Wuhan Hospital Of Traditional Chinese And Western Medicine(WUHAN No.1 HOSPITAL)
Wuhan, Hubei
Jiayao Yang
- Recruiting
The Affiliated Hospital of Shaanxi, University of Chinese Medicine,
Xianyang, Shaanxi, 712000
Jiehong Wang
- Recruiting
Guang'anmen Hospital,China Academy of Chinese Medical Science
Xicheng, Beijing Municipality, 100053
Bin Zhou
- Recruiting
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan
Suping Ma
About this study
To analyze the classification characteristics of gastrointestinal symptoms, the quality of life, the degree of anxiety and depression, and the satisfaction with the treatment of Chinese medicine in patients with FGIDs in Chinese Grade-A Tertiary Hospitals.
The characteristics of TCM（Traditional Chinese Medicine） syndromes and symptoms of the above-mentioned FGIDs will be analyzed, and the characteristics of TCM syndromes of FGIDs and their possible relationship with FGIDs subtypes will be analyzed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rome IV functional gastrointestinal disease diagnosis questionnaire
Fill in only at the time of the patient's consultation, to assess the patient's current situation.Investigation of patients with functional gastrointestinal symptoms according to Rome IV diagnostic criteria.Determine the type of disease based on the questionnaire.
Measured: baseline
Secondary outcomes (3)
PHQ-15 Scale
Fill in only at the time of the patient's consultation, to assess the patient's current situation.Score evaluation from of physical symptoms in patients with functional gastrointestinal disorders from 15 aspects. 0-4 points: very mild， 5-9 points: mild ，10-14 points: moderate，15-30 points: severe.
Measured: baseline
SF-36 Scale
Fill in only at the time of the patient's consultation, to assess the patient's current situation.Score evaluation from 8 aspects: physical function, role-physical, pain, global health status, vitality，social function,role-emotional， mental health.Use score changes to assess improvement in all areas of the patient. Maximum score is147.The higher the score, the better the status in all aspects.
Measured: baseline
Hospital Anxiety and Depression Scale (HADS)
Fill in only at the time of the patient's consultation, to assess the patient's current situation.Scoring to determine if a patient has symptoms of anxiety and depression：(0-7: asymptomatic， 8-10: suspicious symptoms， 11-21: there must be symptoms).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Nov 2019
- Primary completion4 Nov 2019
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Analyze TCM Syndrome and Symptoms of FGIDs PatientsStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 4,632 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225559
- Sponsor's protocol ID
- XL018
- Status last verified
- Dec 2019
- First submitted
- 29 Dec 2019
- Last updated
- 1 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Gastrointestinal Symptoms of Outpatients With Functional Gastrointestinal Diseases（FGIDs） in Grade-A Tertiary Hospitals in China
- ClinicalTrials.gov ID
- NCT04225559
- Acronym / sponsor ID
- XL018
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,632 participants (estimated)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Jan 2020 (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.
To analyze the classification characteristics of gastrointestinal symptoms, the quality of life, the degree of anxiety and depression, and the satisfaction with the treatment of Chinese medicine in patients with FGIDs in Chinese Grade-A Tertiary Hospitals.
The characteristics of TCM（Traditional Chinese Medicine） syndromes and symptoms of the above-mentioned FGIDs will be analyzed, and the characteristics of TCM syndromes of FGIDs and their possible relationship with FGIDs subtypes will be analyzed.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients in Chinese Grade-A tertiary hospitals who has been diagnosed FGIDs
Key inclusion criteria (3 listed)
- Symptoms has appeared for at least 3 months;
- No organic disease and gastrointestinal alarm symptoms, which meet the diagnostic criteria of FGIDs;
- Sign informed consent and be able to read and understand the questionnaire.
Key exclusion criteria (4 listed)
- A history of organic gastrointestinal diseases;
- Alarm symptoms of digestive tract (such as melena, weight loss, fever, abdominal mass, ascites, anemia, family history of gastrointestinal tumors, etc.)
- Have a history of mental diseases;
- Unable to read and understand the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rome IV functional gastrointestinal disease diagnosis questionnaire
Time frame: baseline
Fill in only at the time of the patient's consultation, to assess the patient's current situation.Investigation of patients with functional gastrointestinal symptoms according to Rome IV diagnostic criteria.Determine the type of disease based on the questionnaire.
3 secondary outcomes
PHQ-15 Scale
Time frame: baseline
SF-36 Scale
Time frame: baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Analyze TCM Syndrome and Symptoms of FGIDs Patients, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 16 sites in China.
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 4 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 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China. 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?
Contact Fengyun Wang, Medical Doctor (86-010-62835610, wfy811@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rome IV functional gastrointestinal disease diagnosis questionnaire (time frame: baseline). 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 1 May 2020.