Efficacy and Safety of Changkang Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

A Randomized,Double-blind,Placebo-controlled,Multicenter Study to Evaluate the Efficacy and Safety of Changkang Granule in the Treatment of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D)

The aim of this study is to evaluate the efficacy and safety of Changkang granule as compared to placebo over a 8-week treatment period and explore TCM syndrome types.

Study Overview

• Status: Unknown
• Conditions: Irritable Bowel Syndrome With Diarrhea
• Intervention / Treatment: Drug: Changkang Granule; Drug: Changkang Placebo Granule

Detailed Description

The clinical phase of the study comprises up to 2 weeks of screening for patient's eligibility, a 2-week run-in period , a 8-week double-blind treatment period, and a 4-week safety follow-up.

Patients report their IBS-related symptoms daily from run-in until end of treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rui Liu; Phone Number: 022-86343724; Email: liurui@tasly.com

Study Locations

• China
  • Beijing, China
    • Not yet recruiting
    • Xiyuan Hospital, China Academy of Traditional Chinese Medicine
    • Contact: Hua Zhen Li, director; Phone Number: 13671157196; Email: lixingka@aliyun.com
  • Dalian, China
    • Not yet recruiting
    • Shengjing Hospital of China Medical University
    • Contact: Ning Su Chen, director; Phone Number: 18940251919; Email: chensn@sj-hospital.org
  • Gansu, China
    • Recruiting
    • Gansu provincial hospital of TCM
    • Contact: Dong Xu Tian, director; Phone Number: 15002591589; Email: xytxd@163.com
  • Hunan, China
    • Recruiting
    • The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
    • Contact: Bin Yu, director; Phone Number: 13507314549; Email: Yubin410@163.com
  • Shanghai, China
    • Not yet recruiting
    • Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
    • Contact: Biao Gong, director; Phone Number: 18801800616; Email: rachel_1983@126.com
  • Sichuan, China
    • Not yet recruiting
    • West China Hospital of Sichuan University
    • Contact: Hua Mei Wan, vice-director; Phone Number: 13980082219; Email: meihuawan@hotmail.com
  • Wenzhou, China
    • Recruiting
    • Wenzhou Hospital of Traditional Chinese Medicine
    • Contact: Ming Yao Zeng, director; Phone Number: 13867704929; Email: 250858111@qq.com
  • Xiamen, China
    • Recruiting
    • Xiamen Hospital of Traditional Chinese Medicine
    • Contact: Bin Yi Chen, director; Phone Number: 18950126702; Email: chenyb2004@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The patients with diarrhea predominant irritable bowel syndrome (IBS-D) met Rome IV criteria;
2. It is in accordance with the syndrome differentiation standard of TCM, such as the syndrome of liver Qi multiplying spleen, spleen stomach weakness, spleen kidney yang deficiency or large intestine damp heat syndrome;
3. Male or female aged 18 to 65 years (including the boundary value);
4. The weekly mean NRS score of abdominal pain was ≥ 3.0, and the number of days with stool type 6 or 7 was more than 2 days per week;
5. IBS-SSS score>175;
6. Signed informed consent voluntarily.

Exclusion Criteria:

1. Patients with IBS-C、IBS-M or IBS-U；
2. Those who had been diagnosed with organic diseases of digestive system, such as inflammatory bowel disease, intestinal tuberculosis, intestinal tumor, etc., or still combined with peptic ulcer and infectious diarrhea;
3. Patients were diagnosed with similar symptoms of irritable bowel syndrome in the past, such as eosinophilic enteritis, collagen enteritis, lactose intolerance, etc;
4. Patients with non intestinal diseases of digestive system, such as tuberculous peritonitis, gallstones, liver cirrhosis, chronic pancreatitis, etc;
5. Previous diagnosis of systemic diseases affecting gastrointestinal function, such as hyperthyroidism or hypothyroidism, endometriosis, chronic renal insufficiency, autoimmune diseases, diabetes, etc
6. With history of abdominal surgery (e.g., cholecystectomy);
7. Patients with severe cardiovascular disease, liver, kidney and other major organ diseases, hematopoietic system diseases, tumor, nervous or mental system diseases (such as severe depression, severe anxiety)
8. Those who could not stop using concomitant drugs (prokinetic agents, anticholinergics, calcium channel blockers, 5-HT3 receptor antagonists, antidiarrheal agents, antacids, antidepressants, antianxiety drugs, intestinal flora regulators, etc.) that affected gastrointestinal motility and function ;
9. Taking emergency medication in the run-in period；
10. Pregnant or lactating women；
11. Those who are allergic to the test drug, emergency drug and its ingredients；
12. Suspected or confirmed history of alcohol and drug abuse;
13. Patients who participated in other clinical trials within one month before enrollment;
14. The researchers believe that others are not suitable for clinical trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Changkang Granules	Drug: Changkang Granule; Take Changkang granule before meals twice a day , one bag for each time
PLACEBO_COMPARATOR: Changkang Placebo Granules	Drug: Changkang Placebo Granule; Take Changkang Placebo granule before meals twice a day , one bag for each time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Are Composite Responders Consistency Scores	Composite responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval. The patient will be considered a weekly responder if she/he meets both of the following criteria in the same week.; Abdominal pain response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline;; Stool consistency response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.	8 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Are Responders in Abdominal Pain Scores	Abdominal pain responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval; Weekly response: decrease in weekly average of worst abdominal pain score in the past 24 hours of at least 30% compared with baseline.	8 week
Percentage of Participants Who Are Responders in Stool Consistency Scores	Stool consistency responders are defined as participants who met the weekly response criteria for at least 50% of the weeks with diary entries over the 8-week interval. Weekly response: decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.	8 week
Change from baseline to each week during follow up for IBS-symptoms abdominal pain；	Abdominal Pain：Scored between 0 and 10 (none to severe).	8 week
Change from baseline to each week during follow up for IBS-symptoms stool consistency;	Stool consistency：Bristol Stool Scale（Scored 1-7）.	8 week
Change from baseline to each week during follow up for IBS-symptoms bloating	Bloating：Scored between 0 and 10.	8 week
Change from baseline to each week during follow up for IBS-symptoms urgency	The change of frequency of defecation urgency per week compared with baseline.	8 week
Change from baseline to each week during follow up for IBS-symptoms Defecation frequency	Change from baseline in mean number of bowel movements per week.	8 week
Disappearance rate of traditional Chinese Medicine（TCM）symptom	Each syndrome type has 2-3 symptoms，liver Qi multiplying spleen syndrome includes Chest and flank fullness, depression, irritability	8 week

Collaborators and Investigators

• Sponsor: Tasly Pharmaceutical Group Co., Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 6, 2020
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): October 30, 2022

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (ACTUAL): July 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Changkang Granule
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea
• Other Study ID Numbers: TSL-TCM-CKKL-Ⅱ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No