None listed
Conditions
Brief summary
This study evaluates the clinical efficacy of Rong-Yang-Jyh-Gan-Tang (a combination of long-dan-xie-gan-tang, jia-wei-xia-yao-san, dan-shen and hou-po) on patients with chronic hepatitis C. Rong-Yang-Jyh-Gan-Tang and its ingredients have been proven to have in vitro or in vivo anti-viral, anti-inflammatory, immune modulation effect, and been commonly used in clinical practice of Chinese Medicine in Taiwan. The purpose of this study is to evaluate the clinical efficacy of Rong-Yang-Jyh-Gan-Tang in treating patients with chronic hepatitis C, particularly emphasize on the effect on serum liver transaminase and HCV RNA.
Interventions
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 ma
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.
Sponsors
Commitee on Chinese Medicine and Pharmacy
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 90 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed