Clinical trial NCT04974073: Development of PHY606 as Adjunct Therapy for Anemia Patients
Official title: Development of PHY606 as Adjunct Therapy for Anemia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Herbal Interaction
Keywords: Anemia
Danggui Buxue Tang
PHY606
Side effects
TCM
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 39
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Constitution in Chinese Medicine Questionnaire (CCMQ)
timeFrame: Change from baseline CCMQ at Day0, Day31, Day93 and Day180.
measure: Serum Cytokines
timeFrame: Change from baseline serum cytokines at Day0, Day31 and Day93.
Secondary outcomes:
measure: Tongue diagnosis
timeFrame: Change from baseline tongue diagnosis at Day0 and Day93.
measure: Pulse diagnosis
timeFrame: Change from baseline Pulse diagnosis at Day0 and Day93.
measure: Anemia blood test
timeFrame: Change from baseline anemia blood at Day 0, Day 31 and Day93.
measure: Genotype
timeFrame: Change from baseline genotype at Day 0, Day 31 and Day93.
Other outcomes:
measure: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
timeFrame: Change from baseline FACIT-F score at Day0, Day31, Day93 and Day180.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change from baseline PSQI score at Day0, Day31, Day93 and Day180.
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: Change from baseline SF-36 score at Day0, Day31, Day93 and Day180.
measure: White blood cell (WBC)
timeFrame: Change from baseline WBC at Day 0, Day 31 and Day93.
measure: Red Blood Cells (RBC)
timeFrame: Change from baseline RBC at Day 0, Day 31 and Day93.
measure: Hemoglobin (Hb)
timeFrame: Change from baseline Hemoglobin at Day 0, Day 31 and Day93.
measure: Hematocrit (Hct)
timeFrame: Change from baseline Hematocrit at Day 0, Day 31 and Day93.
measure: Red blood cell volume distribution width (RDW)
timeFrame: Change from baseline RDW at Day 0, Day 31 and Day93.
measure: Platelet
timeFrame: Change from baseline Platelet at Day 0, Day 31 and Day93.
measure: Mean corpuscular volume (MCV)
timeFrame: Change from baseline MCV at Day 0, Day 31 and Day93.
measure: Mean corpuscular hemoglobin (MCH)
timeFrame: Change from baseline MCH at Day 0, Day 31 and Day93.
measure: Mean corpuscular hemoglobin concentration (MCHC)
timeFrame: Change from baseline MCHC at Day 0, Day 31 and Day93.
measure: Mean platelet volume (MPV)
timeFrame: Change from baseline MPV at Day 0, Day 31 and Day93.
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Sheng-Teng Huang, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: