Development of PHY606 as Adjunct Therapy for Anemia Patients

Study Overview
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Brief Summary
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Many reasons can cause anemia, decreased RBC production or increased destruction of circulation RBC. The investigators investigate the Danggui Buxue Tang (PHY606) composed of Angelicae Sinensis Radix and Astragali Radix in the fields of genomic and metabolomics in the healthy people and the patiens with anemia.

Detailed Description
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Many reasons can cause anemia, decreased RBC production or increased destruction of circulating RBC. The reasons of the former are lake of nutrients, bone marrow disorder, low level tropic hormone, inflammation associated with infectious, inflammatory, or malignant disorders and the latter are intravascular hemolysis or blood loss. Anemia is characterized by the sign of pallor (reduced oxyhemoglobin in skin or mucous membranes), fatigue, lightheadedness, and weakness associated with low hemoglobin. Iron deficiency anemia (IDA) is mainly resulted from inadequate iron uptake of food, malabsorption of iron and blood loss. Adult female are easy to have IDA compared to male because of menstruation, pregnancy, lactation and low caloric uptake leading to iron deficiency. In Taiwan, cancer-related and chronic kidney disease also lead to insufficient secretion of erythropoietin (EPO). The cost of long-term use EPO and its derivative drugs is high. Besides, drug resistance, risk of tumor growth and cardiovascular disease are all important issues. However, ferrotherapy will induce GI upset, muscle pain and skin hives. Also, iron supplementation can lead to an increase in infectious disease morbidity in areas where bacterial infections or where malaria are common. Based on the concept of dietetic invigoration, the investigators investigate the Danggui Buxue Tang (PHY606) composed of Angelicae Sinensis Radix and Astragali Radix in the fields of genomics and metabolomics in the healthy people and the patients with anemia. In the meantime, the investigators will explore whether PHY606 activates the immune function, improves anemia and reduces the side effects induced by anemia treatment. Furthermore, the novel metabolites from Angelicae Sinensis Radix and Astragali Radix will be tested from clinic back to the bench including immunological potentiation and hematopoietic function. According to the TCM theory, the investigators integrate with modern medicine and molecular biotechnology to investigate anemia and hope to provide the evidence base for clinical application.

Official Title
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Development of PHY606 as Adjunct Therapy for Anemia Patients

Conditions
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Anemia, Herbal Interaction

Intervention / Treatment
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* Drug: PHY606


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female: Hb<11 g/dL; male: Hb<13.5 g/dL has no allergic reaction to TCM Exclusion Criteria: below 20 years old ever drug abuse or still in drug abuse pregnant or in breast-feeding women with psychotic disorders cardiac arrhythmia with pacemaker dyscoagulation or thrombocytopenia (platelet< 15000/uL) or liver dysfunction (> 2 fold normal range) with severe disease (cardiac arrest, heart failure, COPD, GI bleeding, etc.) under another clinical trials

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>with traditional western medicine treatment based on underlined disease | |
| Experimental: PHY606<br>PHY606 7.5gm BID for 3 months | Drug: PHY606<br>* Danggui Buxue Tang is a well-known TCM formula indicated for anemia through immune modulation and increase energy metabolism<br>* Other names: Danggui Buxue Tang;|
| Other: Healthy group<br>PHY606 7.5gm BID for 2 days | Drug: PHY606<br>* Danggui Buxue Tang is a well-known TCM formula indicated for anemia through immune modulation and increase energy metabolism<br>* Other names: Danggui Buxue Tang;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constitution in Chinese Medicine Questionnaire (CCMQ) |  | Change from baseline CCMQ at Day0, Day31, Day93 and Day180. | 
| Serum Cytokines | Collect blood and measure the level of serum cytokines. | Change from baseline serum cytokines at Day0, Day31 and Day93. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tongue diagnosis | Use tongue photos for analysis | Change from baseline tongue diagnosis at Day0 and Day93. | 
| Pulse diagnosis | Use the pulse detector to detect the rhythm data of the subject's left and right hand pulse. | Change from baseline Pulse diagnosis at Day0 and Day93. | 
| Anemia blood test | Collect blood and measure the level of ferritin(ng/mL), TIBC(ug/dL), transferrin(mg/dL). | Change from baseline anemia blood at Day 0, Day 31 and Day93. | 
| Genotype | Collect blood and analyze the genotype by microarray assay. | Change from baseline genotype at Day 0, Day 31 and Day93. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TCM, Anemia, Danggui Buxue Tang, PHY606, Side effects