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Completed

NCT Number: NCT05687435

Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

The goal of this clinical trial is to test the efficacy and safety of the Chinese patent medicine Changyanning Tablet in the patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D). The main questions it aims to answer are:

1. Can Changyanning Tablet improve diarrhea and abdominal pain in IBS-D patients? 2. Is Changchangning Tablet safe for the treatment of IBS-D?

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Key information

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mei Han，Associate professor，Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet IBS-D Rome IV diagnostic criteria;
  • Age between 18 and 65 years old (including boundary value), regardless of gender;
  • IBS symptom severity scale (IBS-SSS) scores > 175 points;
  • The weekly average score of abdominal pain in screening period is ≥ 3 points (The most severe abdominal pain in the past 24 hours every day, the pain score was 11 grades (0-10), NRS-11; Also the number of days of the stool character classification (Bristol stool scale) is type 6 or 7 ≥ 2 in a week;
  • Patients who voluntarily accept the program's plan of the project and signs the informed consent form.

Exclusion criteria

  • Patients with serious or unstable heart, liver, kidney, immune, endocrine system and other diseases or malignant tumors;
  • Patients are affected by factors such as intellectual disorder, mental disorder and language;
  • Patients with gastrointestinal organic diseases or with malignant tumors, such as pancreatitis, intestinal adenoma (excluding polypectomy for more than half a month), intestinal diverticulum, colon or rectal cancer, inflammatory bowel disease, intestinal tuberculosis, etc;
  • Other diseases (such as hyperthyroidism, diabetes, chronic renal insufficiency, nervous system diseases, etc.) that affect digestive tract dynamics;
  • Complicated with tuberculosis peritonitis, gallstones, cirrhosis, chronic pancreatitis and other gastrointestinal diseases;
  • Allergic constitution or allergic to the components of the studied drug;
  • Pregnant or lactating women, and women with recent fertility plans;
  • Previous abdominal or pelvic surgery, such as cholecystectomy;
  • Patients with positive fecal occult blood;
  • During the screening period, drugs that affect gastrointestinal motility and function cannot be stopped, including parasympathetic inhibitors, such as scopolamine, atropine, belladonna, etc; Muscle relaxants, such as succinylcholine; Antidiarrheal agents such as loperamide, smecta, etc; Opioid preparations, etc;
  • Those who use probiotics (except those who eat yoghurt) or antibiotics within 8 weeks before enrollment in the study;
  • IBS drugs (except polyethylene glycol and loperamide) were used within 3 months before the study;
  • Those who regularly drink alcohol within 6 months before screening, i.e., drink more than 14 units of alcohol every week (1 unit=360 mL beer or 45 mL liquor or 150 mL wine with 40% alcohol);
  • Those who have participated in or are currently participating in other clinical trials within 1 month before screening;
  • The researcher believes that there are patients who are not suitable for inclusion.

Treatment and study plan

Changyanning tablet

Drug

Changyanning Tablet is produced by Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd，composed of Euphorbia humifusa, golden ear grass, camphor tree root, Elsholtzia splendens and maple leaves. It is mainly used for the treatment of acute and chronic intestinal diseases caused by various reasons.

If the symptoms of the subject become worse and unbearable during the study period, it is allowed to add Pinaverium Bromide to the patient according to the specific situation.

Changyanning tablet placebo

Other

Changyanning Tablet placebo is produced by Jiangxi Kang'enbei Traditional Chinese Medicine Co., Ltd. Changyanning Tablet placebo has the same appearance, smell, taste, specifications and packaging with Changyanning Tablet, but does not contain active pharmaceutical ingredients.

If the symptoms of the subject become worse and unbearable during the study period, it is allowed to add Pinaverium Bromide to the patient according to the specific situation.

Primary outcomes

  1. Weekly response rate of abdominal pain and diarrhea

    Time frame: 8 weeks (after treatment)

    The responder is defined when the following two points are met simultaneously： ① Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is at least 30% lower than the baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS).

    ② Fecal traits: the number of days with type 6 or 7 stool traits in a week decreased by at least 50% from the baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits.

    The response rate=(the number of the responders/the sample size of the group) x100%.

Secondary outcomes

  1. Weekly response rate of abdominal pain and diarrhea

    Time frame: 2 weeks, 4 weeks, 6 weeks, 12 weeks

    The responder is defined when the following two points are met simultaneously： ① Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is at least 30% lower than the baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS).

    ② Fecal traits: the number of days with type 6 or 7 stool traits in a week decreased by at least 50% from the baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits.

    The response rate=(the number of the responders/the sample size of the group) x100%.

  2. Weekly response rate of diarrhea

    Time frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks

    The responder is defined when the following two points are met simultaneously： ①Fecal traits: the number of days with type 6 or 7 stool traits in a week decreased by at least 50% from the baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits.

    ②Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is remained unchanged or improved from baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS).

    The response rate=(the number of the responders/the sample size of the group) x100%.

  3. Weekly response rate of abdominal pain

    Time frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks

    The responder is defined when the following two points are met simultaneously： ①Abdominal pain intensity: the most severe abdominal pain score in the past 24 hours, the weekly average value is at least 30% lower than the baseline. To evaluate the intensity of abdominal pain, the patients were asked to grade "the most severe abdominal pain in the past 24 hours" every day by using the 0-10 numerical rating scale (NRS).

    ②Fecal traits: the number of days and frequency with type 6 or 7 stool traits in a week is remained unchanged or decreased from baseline. Refer to Bristol Stool Traits Scale for evaluation of fecal traits.

    The response rate=(the number of the responders/the sample size of the group) x100%.

  4. IBS symptom severity scale（IBS-SSS）scores

    Time frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks

    There are five questions in the scale, each of which has a full score of 100 points and a total score of 500 points. The higher the total score, the more serious the patient's symptoms.

  5. Stool frequency

    Time frame: 2 weeks, 4 weeks, 6 weeks, 8 weeks，12 weeks

    Daily average number of spontaneous defecation in a week.

  6. IBS quality of life (IBS-QOL) scores

    Time frame: 6 weeks, 8 weeks（after treatment），12 weeks（after follow-up）

    The scale consists of 34 items, and each item is divided into five grades: asymptomatic, mild, moderate, overweight, and severe, with corresponding scores of 1-5. The higher the total score, the more serious the patient's symptoms.

Other outcomes

  1. Blood routine test

    Time frame: baseline， 8weeks（after treatment）

    This is a safety outcome.

  2. C-reactive protein

    Time frame: baseline， 8weeks（after treatment）

    This is a safety outcome.

  3. Urine routine test

    Time frame: baseline， 8weeks（after treatment）

    This is a safety outcome.

  4. Stool routine test

    Time frame: baseline， 8weeks（after treatment）

    This is a safety outcome.

  5. Stool occult blood

    Time frame: baseline， 8weeks（after treatment）

    This is a safety outcome.

  6. Liver function-Alanine aminotransferase（ALT）

    Time frame: baseline， 8weeks（after treatment）

    This is a safety outcome.

  7. Liver function-Aspartate aminotransferase (AST)

    Time frame: baseline， 8weeks（after treatment）

    This is a safety outcome.

  8. Liver function-alkaline phosphatase (ALP)

    Time frame: baseline， 8weeks（after treatment）

    This is a safety outcome.

  9. Renal function-blood urea nitrogen (BUN)

    Time frame: baseline， 8weeks（after treatment）

    This is a safety outcome.

  10. Renal function-creatinine

    Time frame: baseline， 8weeks（after treatment）

    This is a safety outcome.

  11. Electrocardiogram

    Time frame: baseline， 8weeks（after treatment）

    This is a safety outcome.

  12. Adverse events

    Time frame: Up to 8 weeks

    This is a safety outcome.

  13. Serious adverse events

    Time frame: Up to 8 weeks

    This is a safety outcome.

Sponsors and collaborators

Lead sponsor

Mei Han

Other

Registry information

Official study title

Changyanning Tablet for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D): A Multicenter, Randomized, Double Blind, Placebo-Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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