A Phase 3 interventional study of Chang Ji'an capsule and Chang Ji'an capsule mimic in IBS, Diarrhea Predominant, sponsored by Beijing Hospital of Traditional Chinese Medicine. Not yet recruiting at 29 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-28.
Sponsored by Beijing Hospital of Traditional Chinese Medicine · Phase 3, Interventional, and Treatment
This trial is a randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase III clinical trial. Its purpose is to evaluate the efficacy and safety of Changji'an Capsules in subjects with diarrhea-predominant irritable bowel syndrome (liver-qi invading spleen syndrome) after 8 weeks of treatment.
24 studies on the registry are indexed under Ichthyosis Bullosa of Siemens; 6 are open to participants now.
This study's planned enrollment of 636 is above the median of 88 across 18 interventional studies indexed under Ichthyosis Bullosa of Siemens.
Browse Ichthyosis Bullosa of Siemens studies →Beijing Hospital of Traditional Chinese Medicine is the lead sponsor of 22 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chang Ji'an Capsules, 4 capsules each time, 3 times a day, orally
Drug: Chang Ji'an capsule
Chang Ji'an Capsules mimic, 4 capsules per dose, 3 times a day, orally
Drug: Chang Ji'an capsule mimic
The prescription consists of 13 medicinal ingredients including Radix Paeoniae Alba, Rhizoma Atractylodis Macrocephalae (processed), and Radix Astragali.
Mock capsules with "no pharmaceutically active ingredients", identical to the Chang Ji'an capsule in color, odor and appearance.
Response rate of diarrhea (stool characteristics) at the end of 8 weeks of treatment
Proportion of subjects who met the following criteria for at least 50% of the period from randomization to the end of Week 8 of treatment: patients with a reduction of at least 50% from baseline in the number of days per week with at least one stool that has a consistency of Type 6 or 7 Bristol Stool Score compared with baseline, and abdominal pain, abdominal distension and abdominal discomfort are unchanged or improved in comparison with baseline.
Time frame: Evaluation will be performed at Day 56.
The abdominal pain response rate at the end of treatment weeks 2, 4, 6 and 8
Proportion of subjects who satisfy the following criteria in no less than 50% of the treatment period from randomization to week endpoint: patients who experience a decrease in the weekly average of worst abdominal pain in the past 24 hours score of at least 30 percent compared with baseline, and the number of days per week with at least one stool with consistency of Type 6 or 7 that is the same as baseline or decreased and the number of stools of Type 6 or 7 on those days remains unchanged or decreased.
Time frame: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
The response rate of diarrhea (stool form) at the end of treatment weeks 2, 4 and 6
Proportion of subjects who met the following criteria for at least 50% of the period from randomization to week endpoint: patients with a reduction of at least 50% from baseline in the number of days per week with at least one stool that has a consistency of Type 6 or 7 Bristol Stool Score compared with baseline, and abdominal pain, abdominal distension and abdominal discomfort are unchanged or improved in comparison with baseline.
Time frame: Evaluation will be performed at baseline and Day 14, Day 28, Day 42.
Treatment response rate at the end of treatment weeks 2, 4, 6 and 8
Defined as the proportion of subjects who meet the following criteria during at least 50% of the treatment period from randomization to the week endpoint: 1.Intensity of abdominal pain, abdominal distension and abdominal discomfort: a decrease in the weekly average of worst abdominal pain, abdominal distension and abdominal discomfort in the past 24 hours score of at least 30 percent compared with baseline; 2.Stool form: 50 percent or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline.
Time frame: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Distention response rate at the end of treatment weeks 2, 4, 6 and 8
Proportion of subjects who satisfy the following criteria in no less than 50% of the treatment period from randomization to week endpoint: patients who experience a decrease in the weekly average of worst abdominal distention in the past 24 hours score of at least 30 percent compared with baseline, and the number of days per week with at least one stool with consistency of Type 6 or 7 that is the same as baseline or decreased and the number of stools of Type 6 or 7 on those days remains unchanged or decreased.
Time frame: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Response rate of abdominal discomfort at the end of 2, 4, 6, and 8 weeks of treatment
Proportion of subjects who satisfy the following criteria in no less than 50% of the treatment period from randomization to week endpoint: patients who experience a decrease in the weekly average of worst abdominal discomfort in the past 24 hours score of at least 30 percent compared with baseline, and the number of days per week with at least one stool with consistency of Type 6 or 7 that is the same as baseline or decreased and the number of stools of Type 6 or 7 on those days remains unchanged or decreased.
Time frame: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Changes in the number of days with diarrhea in the past week compared to baseline at the end of 2, 4, 6, and 8 weeks of treatment
Among patients with unchanged or improved intensity of abdominal pain, abdominal distension and abdominal discomfort, the change from baseline in the number of days with Bristol Stool Form Scale type 6 or 7 at least once during the week.
Time frame: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Changes in the average number of diarrhea episodes in the past week compared to baseline at the end of 2, 4, 6, and 8 weeks of treatment
Defined as the change from baseline in the weekly frequency of Bristol Stool Form Scale Type 6 or 7 stools divided by 7 days, among patients whose intensity of abdominal pain, abdominal distension, and abdominal discomfort remained unchanged or improved.
Time frame: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Changes in Urgency Numeric Rating Scale(Likert 5 point scale, score range:0-4, Lower-is-Better endpoint) compared to baseline at the end of weeks 2, 4, 6, and 8, and in the past 2 weeks
Assessed based on the change in defecation urgency score.
Time frame: Evaluation will be performed at baseline and D14, D28, D42, D56.
Changes from baseline in IBS Symptom Severity Score (IBS-SSS, score range:0-500, Lower-is-Better endpoint) at the end of 2, 4, 6, and 8 weeks of treatment.
Assessed by the changes in scores of the IBS-SSS scales.
Time frame: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Changes from baseline in Quality of Life scale score (IBS-QOL, score range:0-136, Lower-is-Better endpoint) at the end of 2, 4, 6, and 8 weeks of treatment.
Assessed by the changes in scores of the IBS-QOL scales.
Time frame: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Changes from baseline in Traditional Chinese Medicine syndrome score at the end of treatment weeks 2, 4, 6 and 8.
Assessed by the changes in Traditional Chinese Medicine (TCM) syndrome scores.
Time frame: Evaluation will be performed at baseline and Day 14, Day 28, Day 42, Day 56.
Proportion of subjects with sustained remission and no worsening of diarrhea severity at Week 4 and Week 8 during the follow-up period.
Assessed via the Likert scale(Likert 7 point scale, score range:1-7, Lower-is-Better endpoint) completed in ePRO.
Time frame: Evaluations will be performed at baseline, 4 and 8 weeks of the follow-up period after the end of treatment.
Proportion of subjects without diarrhea associated with diarrhea-predominant irritable bowel syndrome at follow-up Week 4 and Week 8.
Assessed via the Likert scale(Likert 7 point scale, score range:1-7, Lower-is-Better endpoint) completed in ePRO.
Time frame: Evaluations will be performed at Day 7, Day 14, Day 21, Day 28, Day 35, Day 42, Day 49, Day 56 after treatment completion.
Usage of rescue medication
Statistical analysis will be performed based on the consumption of rescue medication throughout the entire trial period.
Time frame: Evaluations shall be conducted at Week 8 of treatment.
Plan to share: No
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Ichthyosis Bullosa of Siemens →
Beijing Hospital of Traditional Chinese Medicine