Primary Biliary CholangitisPhase 4NCT06371196
Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule
A Phase 4 study testing Babaodan Capsule in people with Primary Biliary Cholangitis, run by Mei Han.
Trial summary
1. Explore the effect of Babaodan Capsule on the serum total bilirubin level of primary biliary cholangitis patients with elevated total serum bilirubin; 2. To observe the positive intervention effect of Babaodan Capsule on the clinical symptoms of primary biliary cholangitis patients with elevated total bilirubin. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- Babaodan Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2024to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. meets the diagnostic criteria for primary biliary cholangitis (PBC) in the Diagnostic and Therapeutic Guidelines for Primary Biliary Cholangitis (2021), i.e., meets at least 2 out of the following 3 criteria: (i) Biochemical evidence of cholestasis, i.e., elevated ALP and GGT, and imaging studies that exclude extrahepatic or intrahepatic biliary obstruction; (ii) Anti-mitochondrial antibody (AMA) or AMA-M2 positivity or, if AMA negative, PBC-specific antibody (anti-GP210 and/or anti-SP100) positivity; (iii) Histologic evidence suggestive of non-purulent destructive cholangitis and interlobular bile duct destruction.
- 2. Male or female, ≥ 18 years of age and < 75 years of age;
- 3. ursodeoxycholic acid capsule (Yusuf) 10 ~15 mg/d for ≥6 months prior to screening and after screening enrollment, the therapeutic dose was maintained unchanged for the duration of the trial;
- 4. ALP ≥ 1.67 x ULN;
- 5. liver function tests no less than 2 times in the last 3 months, and total bilirubin in liver function tests before enrollment and in the last 3 months are in accordance with the following: 1 × ULN < TBil ≤ 5 × ULN;
- 6. Understand the content of the study, be willing to comply with the study protocol, and voluntarily sign the written informed consent.
Who cannot join
- 1. Combination of or history of other liver diseases, including: (1) hepatitis C virus (HCV) infection; (2) hepatitis B virus (HBV) infection; (3) primary sclerosing cholangitis (PSC); (4) alcoholic liver disease; (5) autoimmune hepatitis (AIH) or overlapping autoimmune liver disease; (6) nonalcoholic steatohepatitis (NASH); (7) drug-induced liver injury; (8) extrahepatic biliary obstruction; (9) Gilbert's syndrome; (10) suspected or diagnosed primary liver cancer; (11) suspected or confirmed primary liver cancer; and (12) extrahepatic biliary obstruction; ⑨ Gilbert's syndrome; ⑩ suspected or confirmed primary liver cancer;
- 2. Presence of clinical complications of PBC, including but not limited to: (i) history of liver transplantation, pending liver transplantation, or current Model for End-Stage Liver Disease (MELD) score ≥ 15; (ii) portal hypertension with complications, including gastric or large esophageal varices, refractory or diuretic-resistant ascites, history of variceal hemorrhage, history of variceal treatment such as use of β-blockers, endoscopic tissue adhesive injections or ligatures, transjugular portacaval shunts, or hepatic encephalopathy; (iii) cirrhosis with Complications, including spontaneous bacterial peritonitis, hepatocellular carcinoma; 4. Hepatorenal syndrome (type I or II) or screening serum creatinine (Cr) ≥ 1.5 x ULN and serum creatinine clearance < 60 mL/min;
- 3. Hepatic function Child-Pugh classification grade B/C;
- 4. ALT ≥ 5 × ULN and/or AST ≥ 5 × ULN;
- 5. ALP > 10 × ULN;
- 6. patients with pruritus with severe itching or requiring systemic medication (e.g., bile acid sequestrants or rifampicin, etc.) within 2 months prior to enrollment
Show all 20Show fewer
- 7. use of the following medications within 3 months prior to enrollment: azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, hexacosanol, dicyclomine, simethicone, ximethicone; fenofibrate or other fibrates; budesonide and other systemic corticosteroids; and hepatotoxic medications (including alpha-methyldopa, valproate, isoniazid, furosemide, etc.);
- 8. use of the following medications within 12 months prior to enrollment and throughout the trial: antibodies or immunotherapies against interleukins or other cytokines or chemokines;
- 9. having or having had a previous cardiac arrhythmia requiring clinical intervention that may affect survival during the trial; or pre-treatment QT prolongation or QTc intervals ≥470ms in men and ≥480ms in women
- 10. pregnant, planning pregnancy, breastfeeding women, women of childbearing potential who do not wish to use effective contraception (≥1 effective method of contraception e.g., condom, hormonal contraceptive pill, intrauterine device), or male subjects who do not wish to use contraception during the trial period and up to 30 days after the last dose of study medication
- 11. patients with co-infections of infectious diseases such as HIV, syphilis, and neo-coronavirus;
- 12. the presence of any other disease or condition that interferes with the absorption, distribution, metabolism, or excretion of the drug (e.g., patients with inflammatory bowel disease or those who have undergone gastric bypass surgery);
- 13. any other disease that is not well controlled or for which the need for the drug is expected to change during the trial;
- 14. persons with a suspected or confirmed history of alcohol or drug abuse within 1 year prior to screening;
- 15. incapacitated or restricted persons;
- 16. subjects who have been enrolled in another study within 30 days prior to Screening
- 17. mentally unstable or incapacitated persons for whom the validity of informed consent or compliance with the trial is uncertain;
- 18. has had a malignant tumor in the last 5 years, with or without treatment and with or without evidence of local recurrence or metastasis;
- 19. the patient has taken Babao Dan capsule within 1 month prior to the trial;
- 20. who, in the opinion of the investigator, should not participate in the trial.
Trial locations and contacts
No sites are listed yet.
About this study
- Explore the effect of Babaodan Capsule on the serum total bilirubin level of primary biliary cholangitis patients with elevated total serum bilirubin;
- To observe the positive intervention effect of Babaodan Capsule on the clinical symptoms of primary biliary cholangitis patients with elevated total bilirubin.
Read the detailed description
- Primary objective: to investigate the effect of Baobao Dan capsule on serum total bilirubin levels in patients with primary biliary cholangitis with elevated total serum bilirubin.
- Secondary objective: to observe the effects of Babaodan Capsule on the following aspects in patients with primary biliary cholangitis with elevated total bilirubin: (1) Other indicators of liver function: ALP, GGT, AST, ALT, TBA, TBil, DBil, IBil; (2) Itching and fatigue symptom scores; (3) Biochemical response rate; (4) Histologic changes; (5) Changes in immunologic indices (serum IgM, IgG, IgA, autoantibodies AMA/AMA-M2 and anti-gp210 antibody, anti-sp100 antibody); (6) Adverse events and safety evaluation.
- Conditions
- Primary Biliary Cholangitis
- Being tested
- Babaodan Capsule
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Babaodan CapsuleDrug
Babao Dan Capsule (State Drug License: Z10940006) is produced by Xiamen Traditional Chinese Medicine Factory Co., Ltd; Packing specification: 0.3g/capsule, 6 capsules/board×2 boards/small box; Ingredients are in vitro cultivated cowhide, snake gallbladder, antelope horn, pearl, panax ginseng, artificial musk, and so on. Intervention measures are really the original UDCA treatment program based on the addition of eight treasure Dan capsule, 2 capsules / times, tid, oral. Course of treatment: 3 months (based on 30 days/month).
| Study group | Role | What they receive |
|---|---|---|
| Babaodan Capsule | Experimental | Babaodan Capsule (State Drug License: Z10940006) is manufactured by Xiamen Traditional Chinese Medicine Factory Co., Ltd; Packing specification: 0.3g/capsule, 6 capsules/board×2 boards/carton; Ingredients are in vitro cultivated cowhide, snake gallbladder, antelope horn, pearl, panax ginseng, artificial musk and so on. Receives: Drug: Babaodan Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total bilirubin (TBil) reversion rate
Total bilirubin (TBil) reversion rate: cases with normal total bilirubin index after treatment/60 cases × 100%
Measured: 90 days
Total bilirubin (TBil) efficacy rate
Total bilirubin (TBil) efficacy rate: total bilirubin index decreased by 1×ULN cases/60 cases×100% after treatment compared with before treatment.
Measured: 90 days
Secondary outcomes (35)
biological response rate
Biological response rate of UDCA combined with Baobao Dan capsule in the treatment of PBC: number of cases meeting the biochemical response standard criteria / 60 cases × 100%. Referring to the UDCA treatment of PBC proposed in the "Diagnostic and therapeutic standard of primary biliary cholangitis (2021)", ALP <1.67×ULN was used as the biochemical response standard.
Measured: 90 days
ALT
The actual level of ALT was collected in the form of measured information.
Measured: 90 days
AST
The actual level of AST was collected in the form of measured information.
Measured: 90 days
ALP
The actual level of ALP was collected in the form of measured information.
Measured: 90 days
TBA
The actual level of TBA was collected in the form of measured information.
Measured: 90 days
DBil
The actual level of DBil was collected in the form of measured information.
Measured: baseline, 30 days, 60 days, 90 days
IBil
The actual level of IBil was collected in the form of measured information.
Measured: 90 days
5-D Pruritus Scale Score
Evaluation was performed according to the 5-D Pruritus Scale Score, which includes 5 aspects of site, duration, intensity, tendency, and impairment of life, with a total score of 5 to 25.
Measured: 90 days
Fatigue section of the PBC-40 questionnaire
It was carried out using the entries of malaise in the Quality of Life Questionnaire for Patients with Primary Biliary Cholangitis (PBC-40), which consisted of 11 items that were categorized according to the degree of malaise as none, seldom, sometimes, often, and continually, with scores of 1, 2, 3, 4, and 5, respectively, and a total score of 11-55.
Measured: 90 days
Immunological indicators - serum IgM
The actual level of serum IgM was collected in the form of measured information.
Measured: 90 days
Immunological indicators - serum IgG
The actual level of serum IgG was collected in the form of measured information.
Measured: 90 days
Immunological indicators - serum IgA
The actual level of serum IgA was collected in the form of measured information.
Measured: 90 days
Immunological indicators - anti-gp210 antibody
The actual level of anti-gp210 antibody was collected in the form of measured information.
Measured: 90 days
Immunological indicators - anti-sp100 antibody
The actual level of anti-sp100 antibody was collected in the form of measured information.
Measured: 90 days
Immunological indicators - autoantibodies AMA/AMA-M2
The actual level of autoantibodies AMA/AMA-M2 was collected in the form of measured information.
Measured: 90 days
Histopathology of the liver - grading of inflammatory activity
Baseline liver puncture biopsy results were valid for 6 months prior to screening, allowing patients to refuse to provide a histologic sample of the liver. The grading of inflammatory activity was observed and changes in the frequency of each corresponding grade were analyzed.
Measured: Changes of 90 days from the baseline.
Histopathology of the liver - staging of the degree of fibrosis
Baseline results of hepatic puncture biopsy were valid for 6 months prior to screening, allowing patients to refuse to provide a histologic sample of the liver. The staging of the degree of fibrosis was observed and changes in the frequency of each corresponding grade were analyzed.
Measured: Changes of 90 days from the baseline.
12-lead electrocardiogram
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal 12-lead electrocardiogram.
Measured: baseline, 30 days, 60 days, 90 days
Physical examination
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal physical examination which concludes general examination of the whole body, head examination, neck examination, chest examination, abdominal examination, etc.
Measured: baseline, 30 days, 60 days, 90 days
Routine blood test
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal routine blood test which concludes RBC, Hb, HCT, MCV, MCHC, RDW, WBC, Neut, Lymph, Mono, Eos, Basso, PLT.
Measured: baseline, 30 days, 60 days, 90 days
Renal Function Tests-BUN
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal BUN.
Measured: baseline, 30 days, 60 days, 90 days
Renal Function Tests-UA
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal UA.
Measured: baseline, 30 days, 60 days, 90 days
Renal Function Tests-Scr
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal Scr.
Measured: baseline, 30 days, 60 days, 90 days
Urinalysis
This is a safety outcome.
Measured: baseline, 30 days, 60 days, 90 days
Coagulation tests-PT
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal PT.
Measured: baseline, 30 days, 60 days, 90 days
Coagulation tests-APTT
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal APTT.
Measured: baseline, 30 days, 60 days, 90 days
Coagulation tests-TT
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal TT.
Measured: baseline, 30 days, 60 days, 90 days
Coagulation tests-FIB
This is a safety outcome. The test operator needs to check the numbers of participants with abnormal FIB.
Measured: baseline, 30 days, 60 days, 90 days
Urine beta-hCG pregnancy test
This is a safety outcome.
Measured: baseline, 30 days, 60 days, 90 days
adverse event
This is a safety outcome.
Measured: baseline, 30 days, 60 days, 90 days, 100 days
Body temperature
This is a safety outcome.
Measured: baseline, 30 days, 60 days, 90 days
Heart rate
This is a safety outcome.
Measured: baseline, 30 days, 60 days, 90 days
Number of breaths in 1 min
This is a safety outcome.
Measured: baseline, 30 days, 60 days, 90 days
Blood pressure-Diastolic blood pressure(mmHg)
This is a safety outcome.
Measured: baseline, 30 days, 60 days, 90 days
Blood pressure-Systolic blood pressure(mmHg)
This is a safety outcome.
Measured: baseline, 30 days, 60 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start25 Apr 2024 (estimated)
- Primary completion25 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mei Han
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mei Han, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371196
- Sponsor's protocol ID
- BBD-PBC 2024-03
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Elevated Total Bilirubin in Primary Biliary Cholangitis With Baobao Dan Capsule
- ClinicalTrials.gov ID
- NCT06371196
- Acronym / sponsor ID
- BBD-PBC 2024-03
- Conditions
- Primary Biliary Cholangitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mei HanUniversity, hospital or other
- Study start
- 25 Apr 2024 (estimated)
- Primary completion
- 25 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Explore the effect of Babaodan Capsule on the serum total bilirubin level of primary biliary cholangitis patients with elevated total serum bilirubin;
- To observe the positive intervention effect of Babaodan Capsule on the clinical symptoms of primary biliary cholangitis patients with elevated total bilirubin.
Detailed description
- Primary objective: to investigate the effect of Baobao Dan capsule on serum total bilirubin levels in patients with primary biliary cholangitis with elevated total serum bilirubin.
- Secondary objective: to observe the effects of Babaodan Capsule on the following aspects in patients with primary biliary cholangitis with elevated total bilirubin: (1) Other indicators of liver function: ALP, GGT, AST, ALT, TBA, TBil, DBil, IBil; (2) Itching and fatigue symptom scores; (3) Biochemical response rate; (4) Histologic changes; (5) Changes in immunologic indices (serum IgM, IgG, IgA, autoantibodies AMA/AMA-M2 and anti-gp210 antibody, anti-sp100 antibody); (6) Adverse events and safety evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Babaodan Capsule | Experimental | Drug: Babaodan CapsuleBabaodan Capsule (State Drug License: Z10940006) is manufactured by Xiamen Traditional Chinese Medicine Factory Co., Ltd; Packing specification: 0.3g/capsule, 6 capsules/board×2 boards/carton; Ingredients are in vitro cultivated cowhide, snake gallbladder, antelope horn, pearl, panax ginseng, artificial musk and so on. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. meets the diagnostic criteria for primary biliary cholangitis (PBC) in the Diagnostic and Therapeutic Guidelines for Primary Biliary Cholangitis (2021), i.e., meets at least 2 out of the following 3 criteria: (i) Biochemical evidence of cholestasis, i.e., elevated ALP and GGT, and imaging studies that exclude extrahepatic or intrahepatic biliary obstruction; (ii) Anti-mitochondrial antibody (AMA) or AMA-M2 positivity or, if AMA negative, PBC-specific antibody (anti-GP210 and/or anti-SP100) positivity; (iii) Histologic evidence suggestive of non-purulent destructive cholangitis and interlobular bile duct destruction.
- 2. Male or female, ≥ 18 years of age and < 75 years of age;
- 3. ursodeoxycholic acid capsule (Yusuf) 10 ~15 mg/d for ≥6 months prior to screening and after screening enrollment, the therapeutic dose was maintained unchanged for the duration of the trial;
- 4. ALP ≥ 1.67 x ULN;
- 5. liver function tests no less than 2 times in the last 3 months, and total bilirubin in liver function tests before enrollment and in the last 3 months are in accordance with the following: 1 × ULN < TBil ≤ 5 × ULN;
Key exclusion criteria (20 listed)
- 1. Combination of or history of other liver diseases, including: (1) hepatitis C virus (HCV) infection; (2) hepatitis B virus (HBV) infection; (3) primary sclerosing cholangitis (PSC); (4) alcoholic liver disease; (5) autoimmune hepatitis (AIH) or overlapping autoimmune liver disease; (6) nonalcoholic steatohepatitis (NASH); (7) drug-induced liver injury; (8) extrahepatic biliary obstruction; (9) Gilbert's syndrome; (10) suspected or diagnosed primary liver cancer; (11) suspected or confirmed primary liver cancer; and (12) extrahepatic biliary obstruction; ⑨ Gilbert's syndrome; ⑩ suspected or confirmed primary liver cancer;
- 2. Presence of clinical complications of PBC, including but not limited to: (i) history of liver transplantation, pending liver transplantation, or current Model for End-Stage Liver Disease (MELD) score ≥ 15; (ii) portal hypertension with complications, including gastric or large esophageal varices, refractory or diuretic-resistant ascites, history of variceal hemorrhage, history of variceal treatment such as use of β-blockers, endoscopic tissue adhesive injections or ligatures, transjugular portacaval shunts, or hepatic encephalopathy; (iii) cirrhosis with Complications, including spontaneous bacterial peritonitis, hepatocellular carcinoma; 4. Hepatorenal syndrome (type I or II) or screening serum creatinine (Cr) ≥ 1.5 x ULN and serum creatinine clearance < 60 mL/min;
- 3. Hepatic function Child-Pugh classification grade B/C;
- 4. ALT ≥ 5 × ULN and/or AST ≥ 5 × ULN;
- 5. ALP > 10 × ULN;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Babaodan CapsuleBabao Dan Capsule (State Drug License: Z10940006) is produced by Xiamen Traditional Chinese Medicine Factory Co., Ltd; Packing specification: 0.3g/capsule, 6 capsules/board×2 boards/small box; Ingredients are in vitro cultivated cowhide, snake gallbladder, antelope horn, pearl, panax ginseng, artificial musk, and so on. Intervention measures are really the original UDCA treatment program based on the addition of eight treasure Dan capsule, 2 capsules / times, tid, oral. Course of treatment: 3 months (based on 30 days/month). | Drug | Babaodan Capsule |
Primary outcome
Total bilirubin (TBil) reversion rate
Time frame: 90 days
Total bilirubin (TBil) reversion rate: cases with normal total bilirubin index after treatment/60 cases × 100%
Total bilirubin (TBil) efficacy rate
Time frame: 90 days
Total bilirubin (TBil) efficacy rate: total bilirubin index decreased by 1×ULN cases/60 cases×100% after treatment compared with before treatment.
35 secondary outcomes
biological response rate
Time frame: 90 days
ALT
Time frame: 90 days
AST
Time frame: 90 days
ALP
Time frame: 90 days
TBA
Time frame: 90 days
DBil
Time frame: baseline, 30 days, 60 days, 90 days
IBil
Time frame: 90 days
5-D Pruritus Scale Score
Time frame: 90 days
Fatigue section of the PBC-40 questionnaire
Time frame: 90 days
Immunological indicators - serum IgM
Time frame: 90 days
Immunological indicators - serum IgG
Time frame: 90 days
Immunological indicators - serum IgA
Time frame: 90 days
Immunological indicators - anti-gp210 antibody
Time frame: 90 days
Immunological indicators - anti-sp100 antibody
Time frame: 90 days
Immunological indicators - autoantibodies AMA/AMA-M2
Time frame: 90 days
Histopathology of the liver - grading of inflammatory activity
Time frame: Changes of 90 days from the baseline.
Histopathology of the liver - staging of the degree of fibrosis
Time frame: Changes of 90 days from the baseline.
12-lead electrocardiogram
Time frame: baseline, 30 days, 60 days, 90 days
Physical examination
Time frame: baseline, 30 days, 60 days, 90 days
Routine blood test
Time frame: baseline, 30 days, 60 days, 90 days
Renal Function Tests-BUN
Time frame: baseline, 30 days, 60 days, 90 days
Renal Function Tests-UA
Time frame: baseline, 30 days, 60 days, 90 days
Renal Function Tests-Scr
Time frame: baseline, 30 days, 60 days, 90 days
Urinalysis
Time frame: baseline, 30 days, 60 days, 90 days
Coagulation tests-PT
Time frame: baseline, 30 days, 60 days, 90 days
Coagulation tests-APTT
Time frame: baseline, 30 days, 60 days, 90 days
Coagulation tests-TT
Time frame: baseline, 30 days, 60 days, 90 days
Coagulation tests-FIB
Time frame: baseline, 30 days, 60 days, 90 days
Urine beta-hCG pregnancy test
Time frame: baseline, 30 days, 60 days, 90 days
adverse event
Time frame: baseline, 30 days, 60 days, 90 days, 100 days
Body temperature
Time frame: baseline, 30 days, 60 days, 90 days
Heart rate
Time frame: baseline, 30 days, 60 days, 90 days
Number of breaths in 1 min
Time frame: baseline, 30 days, 60 days, 90 days
Blood pressure-Diastolic blood pressure(mmHg)
Time frame: baseline, 30 days, 60 days, 90 days
Blood pressure-Systolic blood pressure(mmHg)
Time frame: baseline, 30 days, 60 days, 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Babaodan Capsule in people with Primary Biliary Cholangitis, run by Mei Han.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Shuiping (136660698451, linsp@dinglu.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total bilirubin (TBil) reversion rate (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.