Hepatitis B， ChronicNCT03018821
The Study of Two Different Chinese Traditional Medicine Treatment on Chronic Hepatitis B
A study testing Standard - Yinchengao Decoction plus Ganlu Detoxification Pill, Entecavir or Tenofovir and Standard - Ge Xia Zhu Yu Decoction in people with Hepatitis B， Chronic, run by Xi'an Traditional Medicine Hospital at 1 site in China.
Trial summary
Although the incidence of Hepatitis B has been decreased a lot recently years, there are still quite a few chronic hepatitis B patients in China. The anti-virus drugs of western medicine such as Entecavir and Tenofovir have been proved effective on decreasing the serum hepatitis B virus (HBV) level, on the other hand… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B， Chronic
- What is being tested?
- Standard - Yinchengao Decoction plus Ganlu Detoxification Pill, Entecavir or Tenofovir and Standard - Ge Xia Zhu Yu Decoction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2017
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18<=age at treatment<=65 years old
- Was diagnosed as chronic hepatitis B (ICD10:K73.901) and one of the following Chinese syndromes: hypochondriac pain (TCD:BNG010), jaundice(TCD:BNG020) or abdominal mass (TCD:BNG040).
Who cannot join
- Combined with other virus hepatitis or alcoholic hepatitis
- Combined with autoimmune disease
- Combined with liver cancer or cirrhosis
- Combined with severe hepatitis with or without complications
- Combined with unstable cardio-cerebrovascular disease
- Combined with severe lung, kidney, endocrine system, nervous system and hematological system diseases
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- Combined with Tuberculosis
- Chronic hepatitis patients with ongoing INF treatment
- Woman with pregnancy or breasting feeding
- Mental disorder and can not express self clearly
- Cannot speak Chinese
- Allergic constitution or allergy to multiple drugs
- Refuse to enroll into the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xi'an Traditional Medicine Hospital
Xi'an, Shaanxi
Jianmei Hao, MD, 86-29-89626651, 12479088@qq.com
About this study
Official title: Efficacy Comparison Between Two Kind of Chinese Herbal Formulas on Traditional Chinese Medicine Syndromes Among Chronic Hepatitis Patients
Although the incidence of Hepatitis B has been decreased a lot recently years, there are still quite a few chronic hepatitis B patients in China. The anti-virus drugs of western medicine such as Entecavir and Tenofovir have been proved effective on decreasing the serum hepatitis B virus (HBV) level, on the other hand, Chinese materia medica showed effective on TCM syndromes of chronic hepatitis B (CHB) such as hypochondriac pain, jaundice and abdominal mass. Besides, the hepatic fibrosis could be delayed after the appropriate treatment of TCM. This study is a multicenter, randomized, open label, parallel group clinical trial to evaluate the efficacy of two different traditional Chinese medicine (TCM) herbal treatment on chronic hepatitis B.
- Conditions
- Hepatitis B， Chronic
- Being tested
- Standard - Yinchengao Decoction plus Ganlu Detoxification Pill, Entecavir or Tenofovir, Standard - Ge Xia Zhu Yu Decoction, Advanced - Supplemented Taohong Huazhuo Decoction, Standard - Chaihu Shugan San
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard - Yinchengao Decoction plus Ganlu Detoxification PillDrug
Yinchengao Decoction plus Ganlu Detoxification Pill is one Chinese Medicine Formula for the TCM syndrome: Damp-heat blocking middle jiao.
Entecavir or TenofovirDrug
Western drug for anti-HBV such as Entecavir and Tenofovir
Standard - Ge Xia Zhu Yu DecoctionDrug
Ge Xia Zhu Yu Decoction is one Chinese Medicine Formula for the TCM syndrome: internal blood stasis.
Advanced - Supplemented Taohong Huazhuo DecoctionDrug
Supplemented Taohong Huazhuo Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Damp-heat blocking middle jiao.
Standard - Chaihu Shugan SanDrug
Chaihu Shugan San is one Chinese Medicine Formula for the TCM syndrome: Liver depression and qi stagnation.
Advanced - Soothe the liver and regulate qi DecoctionDrug
Soothe the liver and regulate qi Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Liver depression and qi stagnation.
Standard - Xiaoyao powderDrug
Xiaoyao powder is one Chinese Medicine Formula for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
Advanced - Supplemented Ganbi DecoctionDrug
Supplemented Ganbi Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
Standard - Yiguan DecoctionDrug
Yiguan Decoction is one Chinese Medicine Formula for the TCM syndrome: Yin deficiency of liver and kidney.
Advanced - Supplemented Zimu DanDrug
Supplemented Zimu Dan is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Yin deficiency of liver and kidney.
Standard - Fuzilizhong Decoction plus Jinkui Shenqi BolusDrug
Fuzilizhong Decoction plus Jinkui Shenqi Bolus is one Chinese Medicine Formula for the TCM syndrome: Yang deficiency of spleen and kidney.
Advanced - Guifu Erxian DecoctionDrug
Guifu Erxian Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Yang deficiency of spleen and kidney.
Advanced - Supplemented Ganji DecoctionDrug
Supplemented Ganji Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: internal blood stasis.
| Study group | Role | What they receive |
|---|---|---|
| Standard CMF | Active comparator | Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir).
1. Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
2. Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation
3. Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
4. Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney
5. Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney
6. Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis Receives: Drug: Standard - Yinchengao Decoction plus Ganlu Detoxification Pill; Drug: Entecavir or Tenofovir; Drug: Standard - Ge Xia Zhu Yu Decoction; Drug: Standard - Chaihu Shugan San; Drug: Standard - Xiaoyao powder; Drug: Standard - Yiguan Decoction; Drug: Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus |
| Advanced CMF | Experimental | Advanced TCM formulas for corresponding TCM syndromes provided by famous TCM doctors who were national wide known in China, plus an anti-virus western drugs (such as Entecavir or Tenofovir).
1. Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao
2. Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation
3. Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
4. Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney
5. Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney
6. Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis Receives: Drug: Entecavir or Tenofovir; Drug: Advanced - Supplemented Taohong Huazhuo Decoction; Drug: Advanced - Soothe the liver and regulate qi Decoction; Drug: Advanced - Supplemented Ganbi Decoction; Drug: Advanced - Supplemented Zimu Dan; Drug: Advanced - Guifu Erxian Decoction; Drug: Advanced - Supplemented Ganji Decoction |
| Pure Entecavir or Tenofovir | Experimental | Use an anti-virus western drug alone (such as Entecavir or Tenofovir). Receives: Drug: Entecavir or Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traditional Chinese Medicine symptom scale
Measured: Change of TCM symptom scale between baseline and sixth months of treatment
Secondary outcomes (2)
The change of liver fibrosis
Use change of FibroScan measurement of liver between baseline and 6th months of treatment to express the change of liver fibrosis
Measured: Chnage of liver fibrosis between baseline and 6th months of treatment
Overall effectiveness of treatment defined by the guidelines for prevention and treatment of chronic hepatitis B
Treatments were completely effective, partially effective or not effective after treatment.
Complete effective: Alanine aminotransferase normal, HBV DNA, HBeAg and HBsAg are negative
Partially effective: Alanine aminotransferase normal, HBV DNA, HBeAg are negative and HBsAg stay positive
Not effective: Did not reach any one of what are listed above.
Measured: Overall effectiveness of treatment between baseline and 6th months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B， ChronicStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Traditional Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018821
- Sponsor's protocol ID
- XAZYYLS2017-02
- Status last verified
- Jan 2017
- First submitted
- 6 Jan 2017
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Comparison Between Two Kind of Chinese Herbal Formulas on Traditional Chinese Medicine Syndromes Among Chronic Hepatitis Patients
- ClinicalTrials.gov ID
- NCT03018821
- Acronym / sponsor ID
- XAZYYLS2017-02
- Conditions
- Hepatitis B， Chronic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Xi'an Traditional Medicine HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- 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.
Although the incidence of Hepatitis B has been decreased a lot recently years, there are still quite a few chronic hepatitis B patients in China. The anti-virus drugs of western medicine such as Entecavir and Tenofovir have been proved effective on decreasing the serum hepatitis B virus (HBV) level, on the other hand, Chinese materia medica showed effective on TCM syndromes of chronic hepatitis B (CHB) such as hypochondriac pain, jaundice and abdominal mass. Besides, the hepatic fibrosis could be delayed after the appropriate treatment of TCM. This study is a multicenter, randomized, open label, parallel group clinical trial to evaluate the efficacy of two different traditional Chinese medicine (TCM) herbal treatment on chronic hepatitis B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard CMF | Active comparator | Drug: Standard - Yinchengao Decoction plus Ganlu Detoxification Pill, Drug: Entecavir or Tenofovir, Drug: Standard - Ge Xia Zhu Yu Decoction, Drug: Standard - Chaihu Shugan San, Drug: Standard - Xiaoyao powder, Drug: Standard - Yiguan Decoction, Drug: Standard - Fuzilizhong Decoction plus Jinkui Shenqi BolusStandard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir). 1. Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation 3. Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney 5. Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney 6. Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis |
| Advanced CMF | Experimental | Drug: Entecavir or Tenofovir, Drug: Advanced - Supplemented Taohong Huazhuo Decoction, Drug: Advanced - Soothe the liver and regulate qi Decoction, Drug: Advanced - Supplemented Ganbi Decoction, Drug: Advanced - Supplemented Zimu Dan, Drug: Advanced - Guifu Erxian Decoction, Drug: Advanced - Supplemented Ganji DecoctionAdvanced TCM formulas for corresponding TCM syndromes provided by famous TCM doctors who were national wide known in China, plus an anti-virus western drugs (such as Entecavir or Tenofovir). 1. Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation 3. Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney 5. Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney 6. Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis |
| Pure Entecavir or Tenofovir | Experimental | Drug: Entecavir or TenofovirUse an anti-virus western drug alone (such as Entecavir or Tenofovir). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18<=age at treatment<=65 years old
- Was diagnosed as chronic hepatitis B (ICD10:K73.901) and one of the following Chinese syndromes: hypochondriac pain (TCD:BNG010), jaundice(TCD:BNG020) or abdominal mass (TCD:BNG040).
Key exclusion criteria (13 listed)
- Combined with other virus hepatitis or alcoholic hepatitis
- Combined with autoimmune disease
- Combined with liver cancer or cirrhosis
- Combined with severe hepatitis with or without complications
- Combined with unstable cardio-cerebrovascular disease
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 |
|---|---|---|
| Standard - Yinchengao Decoction plus Ganlu Detoxification PillYinchengao Decoction plus Ganlu Detoxification Pill is one Chinese Medicine Formula for the TCM syndrome: Damp-heat blocking middle jiao. | Drug | Standard CMF |
| Entecavir or TenofovirWestern drug for anti-HBV such as Entecavir and Tenofovir | Drug | Advanced CMF, Pure Entecavir or Tenofovir, Standard CMF |
| Standard - Ge Xia Zhu Yu DecoctionGe Xia Zhu Yu Decoction is one Chinese Medicine Formula for the TCM syndrome: internal blood stasis. | Drug | Standard CMF |
| Advanced - Supplemented Taohong Huazhuo DecoctionSupplemented Taohong Huazhuo Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Damp-heat blocking middle jiao. | Drug | Advanced CMF |
| Standard - Chaihu Shugan SanChaihu Shugan San is one Chinese Medicine Formula for the TCM syndrome: Liver depression and qi stagnation. | Drug | Standard CMF |
| Advanced - Soothe the liver and regulate qi DecoctionSoothe the liver and regulate qi Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Liver depression and qi stagnation. | Drug | Advanced CMF |
| Standard - Xiaoyao powderXiaoyao powder is one Chinese Medicine Formula for the TCM syndrome: Stagnation of liver qi and spleen deficiency. | Drug | Standard CMF |
| Advanced - Supplemented Ganbi DecoctionSupplemented Ganbi Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Stagnation of liver qi and spleen deficiency. | Drug | Advanced CMF |
| Standard - Yiguan DecoctionYiguan Decoction is one Chinese Medicine Formula for the TCM syndrome: Yin deficiency of liver and kidney. | Drug | Standard CMF |
| Advanced - Supplemented Zimu DanSupplemented Zimu Dan is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Yin deficiency of liver and kidney. | Drug | Advanced CMF |
| Standard - Fuzilizhong Decoction plus Jinkui Shenqi BolusFuzilizhong Decoction plus Jinkui Shenqi Bolus is one Chinese Medicine Formula for the TCM syndrome: Yang deficiency of spleen and kidney. | Drug | Standard CMF |
| Advanced - Guifu Erxian DecoctionGuifu Erxian Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Yang deficiency of spleen and kidney. | Drug | Advanced CMF |
| Advanced - Supplemented Ganji DecoctionSupplemented Ganji Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: internal blood stasis. | Drug | Advanced CMF |
Primary outcome
Traditional Chinese Medicine symptom scale
Time frame: Change of TCM symptom scale between baseline and sixth months of treatment
2 secondary outcomes
The change of liver fibrosis
Time frame: Chnage of liver fibrosis between baseline and 6th months of treatment
Overall effectiveness of treatment defined by the guidelines for prevention and treatment of chronic hepatitis B
Time frame: Overall effectiveness of treatment between baseline and 6th months of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard - Yinchengao Decoction plus Ganlu Detoxification Pill, Entecavir or Tenofovir and Standard - Ge Xia Zhu Yu Decoction in people with Hepatitis B， Chronic, run by Xi'an Traditional Medicine Hospital at 1 site in China.
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 2 inclusion and 13 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Jianmei Hao, MD (86-29-89626651, 12479088@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Traditional Chinese Medicine symptom scale (time frame: Change of TCM symptom scale between baseline and sixth months of treatment). 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 12 Jan 2017.