Development of PHY606 as Adjunct Therapy for Anemia Patients

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Herbal Interaction
• Intervention / Treatment: Drug: PHY606

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)		Change from baseline FACIT-F score at Day0, Day31, Day93 and Day180.
Pittsburgh Sleep Quality Index (PSQI)		Change from baseline PSQI score at Day0, Day31, Day93 and Day180.
36-Item Short Form Health Survey (SF-36)		Change from baseline SF-36 score at Day0, Day31, Day93 and Day180.
White blood cell (WBC)	Collect blood and measure the value of WBC (x 10^3/ul).	Change from baseline WBC at Day 0, Day 31 and Day93.
Red Blood Cells (RBC)	Collect blood and measure the value of RBC (x 10^6/ul).	Change from baseline RBC at Day 0, Day 31 and Day93.
Hemoglobin (Hb)	Collect blood and measure the value of Hemoglobin (gm/dL).	Change from baseline Hemoglobin at Day 0, Day 31 and Day93.
Hematocrit (Hct)	Collect blood and measure the value of Hematocrit (%).	Change from baseline Hematocrit at Day 0, Day 31 and Day93.
Red blood cell volume distribution width (RDW)	Collect blood and measure the value of RDW (%).	Change from baseline RDW at Day 0, Day 31 and Day93.
Platelet	Collect blood and measure the value of Platelet (x 10^3/ul).	Change from baseline Platelet at Day 0, Day 31 and Day93.
Mean corpuscular volume (MCV)	Collect blood and measure the value of MCV (fl).	Change from baseline MCV at Day 0, Day 31 and Day93.
Mean corpuscular hemoglobin (MCH)	Collect blood and measure the value of MCH (pg).	Change from baseline MCH at Day 0, Day 31 and Day93.
Mean corpuscular hemoglobin concentration (MCHC)	Collect blood and measure the value of MCHC (g/dL).	Change from baseline MCHC at Day 0, Day 31 and Day93.
Mean platelet volume (MPV)	Collect blood and measure the value of MPV (fl).	Change from baseline MPV at Day 0, Day 31 and Day93.

Collaborators and Investigators

• Sponsor: Sheng-Teng Huang
• Investigators: Principal Investigator: Sheng-Teng Huang, MD PhD, China Medical University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2017
• Primary Completion (Actual): August 22, 2017
• Study Completion (Actual): November 18, 2019

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: July 13, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Anemia; Side effects; TCM; Danggui Buxue Tang; PHY606
• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: CMUH106-REC3-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No