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Efficacy Assessment of Chinese Herbal Medicine Tangweian Recipe Treating Participants With Diabetic Gastroenteropathy

Primary Purpose

Diabetic Gastroenteropathy

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tangweian Recipe
Mosapride Citrate
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Gastroenteropathy focused on measuring Diabetic Gastroenteropathy

Eligibility Criteria

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

Inclusion Criteria: Aged 18 to 70 years at the time of their consent; Those diagnosed with diabetic gastrointestinal lesions with gastrointestinal symptoms such as nausea/vomiting, early satiety, bloating, and epigastric pain for more than 3 months or longer; History of symptoms of mellitus for at least 5 years leading up to the Screening Visit and Blood glucose stable within 1 month; Mean Gastroparesis Cardinal Symptom Index (GCSI) score ≥ 2; or delayed gastric emptying confirmed at screening by gastric emptying breath test (GEBT); TCM Syndrome differentiation as spleen deficiency and stomach stagnation syndrome; Signed informed consent. Exclusion Criteria: Patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month; Patients with gastrointestinal reactions caused by glucose-lowering drugs and patients treated with GLP-1 class drugs; Have a history of or are suffering from severe gastrointestinal disease Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year; Combination of severe cardiovascular and cerebrovascular diseases, hepatic and renal insufficiency, psychiatric patients, drug abuse and dependence; Women who are pregnant, preparing for pregnancy or breastfeeding; Patients who participated in other clinical studies within one month prior to participating in this study or were participating in other clinical studies; According to the judgment of the researcher, other diseases or conditions that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment and unstable living environment, are likely to cause loss of follow-up.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tangweian Recipe Group

    Mosapride Citrate Group

    Arm Description

    Tangweian formula granule (30g per bag), 1 bag per time, twice a day, take it with warm water after meals. 1 mosapride citratetablet per time, 3 times a day, take it with meals.

    1 mosapride citratetablet per time, 3 times a day, take it with meals.

    Outcomes

    Primary Outcome Measures

    Sub-scores of the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)
    Change from Baseline at weeks 0 through 4 as measured by patient's daily diary entries during participation in the study.
    Patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM)

    Secondary Outcome Measures

    Changes from Baseline Fasting Blood Glucose at 4 weeks
    Changes from Baseline Body Mass Index at 4 weeks
    Change from Baseline TCM Symptom Score at 4 weeks
    SF-36 Health Survey Questionnaire

    Full Information

    First Posted
    January 31, 2023
    Last Updated
    January 31, 2023
    Sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05720442
    Brief Title
    Efficacy Assessment of Chinese Herbal Medicine Tangweian Recipe Treating Participants With Diabetic Gastroenteropathy
    Official Title
    Efficacy Assessment of Chinese Herbal Medicine Tangweian Recipe Treating Participants With Diabetic Gastroenteropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    January 31, 2025 (Anticipated)
    Study Completion Date
    January 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study is a randomized, positive drug parallel-controlled clinical trial in participants with diabetic gastroenteropathy. A total of 60 participants will be recruited for the study, all of whom are diagnosed as diabetes mellitus combined with gastroenteropathy. The subjects will be divided randomly into two groups and treated with either Tangweian Recipe+mosapride citrate tablets or mosapride citrate tablets for four weeks. The primary outcome will be the change in gastroparesis symptom severity, as measured by the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Daily diary Index-Daily Diary (ANMS GCSI-DD). And participants will be seen for a clinic evaluation at weeks 0 and 4, during which symptom scores, adverse events and treatment compliance will be assessed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Gastroenteropathy
    Keywords
    Diabetic Gastroenteropathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tangweian Recipe Group
    Arm Type
    Experimental
    Arm Description
    Tangweian formula granule (30g per bag), 1 bag per time, twice a day, take it with warm water after meals. 1 mosapride citratetablet per time, 3 times a day, take it with meals.
    Arm Title
    Mosapride Citrate Group
    Arm Type
    Active Comparator
    Arm Description
    1 mosapride citratetablet per time, 3 times a day, take it with meals.
    Intervention Type
    Drug
    Intervention Name(s)
    Tangweian Recipe
    Intervention Description
    The Tangweian recipe is a combination of several Chinese herbs
    Intervention Type
    Drug
    Intervention Name(s)
    Mosapride Citrate
    Intervention Description
    The mosapride citrate tablets will be administrated.
    Primary Outcome Measure Information:
    Title
    Sub-scores of the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptoms Index-Daily Diary (ANMS GCSI-DD)
    Description
    Change from Baseline at weeks 0 through 4 as measured by patient's daily diary entries during participation in the study.
    Time Frame
    Baseline to Week 4
    Title
    Patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM)
    Time Frame
    0 week, 4 weeks
    Secondary Outcome Measure Information:
    Title
    Changes from Baseline Fasting Blood Glucose at 4 weeks
    Time Frame
    0 week, 4 weeks
    Title
    Changes from Baseline Body Mass Index at 4 weeks
    Time Frame
    0 week, 4 weeks
    Title
    Change from Baseline TCM Symptom Score at 4 weeks
    Time Frame
    0 week, 4 weeks
    Title
    SF-36 Health Survey Questionnaire
    Time Frame
    0 week, 4 weeks
    Other Pre-specified Outcome Measures:
    Title
    Adverse events (AEs)
    Time Frame
    0 week, 4 weeks

    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: Aged 18 to 70 years at the time of their consent; Those diagnosed with diabetic gastrointestinal lesions with gastrointestinal symptoms such as nausea/vomiting, early satiety, bloating, and epigastric pain for more than 3 months or longer; History of symptoms of mellitus for at least 5 years leading up to the Screening Visit and Blood glucose stable within 1 month; Mean Gastroparesis Cardinal Symptom Index (GCSI) score ≥ 2; or delayed gastric emptying confirmed at screening by gastric emptying breath test (GEBT); TCM Syndrome differentiation as spleen deficiency and stomach stagnation syndrome; Signed informed consent. Exclusion Criteria: Patients with diabetic ketoacidosis, hyperosmolar nonketotic diabetic coma, severe infection, and surgery in recent one month; Patients with gastrointestinal reactions caused by glucose-lowering drugs and patients treated with GLP-1 class drugs; Have a history of or are suffering from severe gastrointestinal disease Gastrectomy, fundoplication, vagotomy, pyloroplasty, bariatric surgery, or gastric stimulation device surgically implanted within the last year; Combination of severe cardiovascular and cerebrovascular diseases, hepatic and renal insufficiency, psychiatric patients, drug abuse and dependence; Women who are pregnant, preparing for pregnancy or breastfeeding; Patients who participated in other clinical studies within one month prior to participating in this study or were participating in other clinical studies; According to the judgment of the researcher, other diseases or conditions that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in working environment and unstable living environment, are likely to cause loss of follow-up.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jiaxing Tian
    Phone
    86+01088002289
    Email
    tina_yai@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuxin Zhang
    Email
    yuxin_zhang96@163.com

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy Assessment of Chinese Herbal Medicine Tangweian Recipe Treating Participants With Diabetic Gastroenteropathy

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