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

Irritable Bowel Syndrome With Diarrhea Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04492787
• Other study ID #: TSL-TCM-CKKL-?
• Status: Recruiting
• Phase: Phase 2
• Start date: June 6, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: June 2020
• Source: Tasly Pharmaceutical Group Co., Ltd
• Contact: Rui Liu
• Phone: 022-86343724
• Email: liurui[@]tasly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

Intervention

Drug:
• Changkang Granule
Take Changkang granule before meals twice a day , one bag for each time
• Changkang Placebo Granule
Take Changkang Placebo granule before meals twice a day , one bag for each time

Locations

Country	Name	City	State
China	Xiyuan Hospital, China Academy of Traditional Chinese Medicine	Beijing
China	Shengjing Hospital of China Medical University	Dalian
China	Gansu Provincial Hospital of TCM	Gansu
China	The first affiliated Hospital of Hunan University of Traditional Chinese Medicine	Hunan
China	Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai
China	West China Hospital of Sichuan University	Sichuan
China	Wenzhou Hospital of Traditional Chinese Medicine	Wenzhou
China	Xiamen Hospital of Traditional Chinese Medicine	Xiamen

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Pharmaceutical Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change from baseline to each week during follow up for IBS-symptoms stool consistency;	Stool consistency:Bristol Stool Scale(Scored 1-7).	8 week
Secondary	Change from baseline to each week during follow up for IBS-symptoms bloating	Bloating:Scored between 0 and 10.	8 week
Secondary	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
Secondary	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
Secondary	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