Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000229774
Ethics application status
Approved
Date submitted
22/02/2013
Date registered
27/02/2013
Date last updated
27/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical efficacy of Rong-Yang-Jyh-Gan-Tang on patients with chronic hepatitis C: a double-blinded randomized placebo-controlled cross-over study
Scientific title
Clinical efficacy of Rong-Yang-Jyh-Gan-Tang on patients with chronic hepatitis C: a double-blinded randomized placebo-controlled cross-over study
Secondary ID [1] 281914 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic hepatitis C 288312 0
Condition category
Condition code
Alternative and Complementary Medicine 288667 288667 0 0
Herbal remedies
Oral and Gastrointestinal 288823 288823 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with chronic hepatitis C who were not responsive or not suitable for standard interferon-based therapy are enrolled into this study. Patients are diagnosed first by Chinese herbal doctor to identified as “dampness heat stasis” and “liver Qi stagnation” by Bian-Zheng-lun-zhi (diagnosis and treatment with Traditional Chinese Medicine) and then randomized and allocated to receive Rong-Yang-Jyh-Gan-Tang (a combination of long-dan-xie-gan-tang, jia-wei-xia-yao-san, dan-shen and hou-po and made into a pastille to be taken orally) 15gm per day and three times a day. After 2 weeks’ washout period, patients are crossed over to receive placebo for another 12 weeks. Furthermore, those patients who had response continue to receive a 24 weeks course of Rong-Yang-Jyh-Gan-Tang to evaluate the sustained response 24 weeks after stopping treatment.
Intervention code [1] 286479 0
Treatment: Other
Comparator / control treatment
Patients with chronic hepatitis C are received placebo (starch which is made into a pastille to be taken orally) for 12weeks. After 2 weeks’ washout period, patients will be crossed over to receive Rong-Yang-Jyh-Gan-Tang for another 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 288814 0
Liver biochemistries: the serum liver transaminases ratio (ALT / AST)
Timepoint [1] 288814 0
At baseline, 4, 8, 12, 16, 20, 24, 28, 32, 36 and 48 weeks after randomisation
Primary outcome [2] 288816 0
Blood tests for complete blood count(CBC) and the renal function(Bun, Cr.)
Timepoint [2] 288816 0
At baseline, 12, 24, 36 and 48weeks after randomisation
Primary outcome [3] 288817 0
Blood test for HCV viral load
Timepoint [3] 288817 0
At baseline, 4, 12, 24, 28 and 48 weeks after randomisation
Secondary outcome [1] 301059 0
Chinese Medicine symptoms score
Timepoint [1] 301059 0
At baseline, 4, 8, 12, 16, 20, 24, 28, 36 and 48 weeks after randomisation
Secondary outcome [2] 301060 0
Fatigue severity score
Timepoint [2] 301060 0
At baseline, 12, 24, 28, 36 and 48weeks after randomisation
Secondary outcome [3] 301061 0
Quality of life questionnaire (SF-36)
Timepoint [3] 301061 0
At baseline, 24 and 48 weeks after randomisation

Eligibility
Key inclusion criteria
1. Chronic hepatitis C patients are older than twenty years old; Anti-HCV reaction is positive.
2. HCV RNA load is positive (greater than 15IU/ml), Alanine Aminotransferase (ALT) is greater than the standard value(40U / L).
3. Had failed in receiving the standard interferon-based treatment (including non-response and recurrence), or are not candidates for interferon treatment for hepatitis C patients.
Minimum age
20 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients had symptoms of acute diarrhea over the past two weeks.
2. Pregnant women or breastfeeding women.
3. Patients had compensatory disorders of liver disease or liver cirrhosis, such as esophageal variceal bleeding, ascites, hepatic encephalopathy, bilirubin greater than 2.0mg/dl and spontaneous bacterial peritonitis over the past six months.
4. Liver cancer or other treatment in malignant tumor.
5. Combined hepatitis B virus or HIV infection.
6. Drug or alcohol abuse.
7. Having allergies in Traditional Chinese medicine preparation.
8. Serious systemic diseases, such as severe cardiopulmonary disease or illness which will affect clinical research proceeding and evaluation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be enrolled with chronic hepatitis C who were not responsive or not suitable for standard interferon-based therapy into this study. Patients will be diagnosed first by Chinese herbal doctor to identified as “dampness heat stasis” and “liver Qi stagnation” by Bian-Zheng-lun-zhi (diagnosis and treatment with Traditioal Chinese Medicine) and then randomized and allocated by random number table to receive Rong-Yang-Jyh-Gan-Tang/placebo. Participants are concealed by allocating from collected sequence: single for A and plural for B.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Rong-Yang-Jyh-Gan-Tang therapy between the treatment group and the placebo group with sex stratified analysis for comparison of serum liver transaminases and HCV viral load reduction ratio uses Fisher’s Exact test. Traditional Chinese Medicine (TCM) syndromes, fatigue scale, and 36-Item Short Form Health Survey (SF-36) quality of life scale improvement between the two groups use Fisher's Exact test by categorical variables, and use the Mann Whitney U test by quantify variables. Values of serum liver transaminase, HCV viral load that patients treat with Rong-Yang-Jyh-Gan-Tang, and other quantitative indicators use Wilcoxon signed rank test analysis and categorical variables use McNemar Chi-Square test analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/09/2012
Actual
25/09/2012
Date of last participant enrolment
Anticipated
15/12/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 4858 0
Taiwan, Province Of China
State/province [1] 4858 0

Funding & Sponsors
Funding source category [1] 286712 0
Government body
Name [1] 286712 0
Department of Health, Executive Yuan
Country [1] 286712 0
Taiwan, Province Of China
Primary sponsor type
Government body
Name
Commitee on Chinese Medicine and Pharmacy
Address
No. 6, Shuangcheng St., Jhongshang District, Taipei City, 104
Country
Taiwan, Province Of China
Secondary sponsor category [1] 285484 0
Hospital
Name [1] 285484 0
Taipei Veterans General Hospital
Address [1] 285484 0
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217
Country [1] 285484 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37690 0
Prof Shinn-jang Huang
Address 37690 0
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217
Country 37690 0
Taiwan, Province Of China
Phone 37690 0
886-2-28757458
Fax 37690 0
Email 37690 0
[email protected]
Contact person for public queries
Name 37691 0
Shinn-jang Huang
Address 37691 0
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217
Country 37691 0
Taiwan, Province Of China
Phone 37691 0
886-2-28757458
Fax 37691 0
Email 37691 0
[email protected]
Contact person for scientific queries
Name 37692 0
Shinn-jang Huang
Address 37692 0
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217
Country 37692 0
Taiwan, Province Of China
Phone 37692 0
886-2-28757458
Fax 37692 0
Email 37692 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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