Development of PHY606 as Adjunct Therapy for Anemia Patients

Anemia Clinical Trial

Official title:

Development of PHY606 as Adjunct Therapy for Anemia Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04974073
• Other study ID #: CMUH106-REC3-028
• Status: Completed
• Phase: Phase 3
• Start date: August 22, 2017
• Est. completion date: November 18, 2019

Study information

• Verified date: August 2021
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 18, 2019
• Est. primary completion date: August 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Herbal Interaction

Intervention

Drug:
• PHY606
Danggui Buxue Tang is a well-known TCM formula indicated for anemia through immune modulation and increase energy metabolism

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Sheng-Teng Huang

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)		Change from baseline FACIT-F score at Day0, Day31, Day93 and Day180.
Other	Pittsburgh Sleep Quality Index (PSQI)		Change from baseline PSQI score at Day0, Day31, Day93 and Day180.
Other	36-Item Short Form Health Survey (SF-36)		Change from baseline SF-36 score at Day0, Day31, Day93 and Day180.
Other	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.
Other	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.
Other	Hemoglobin (Hb)	Collect blood and measure the value of Hemoglobin (gm/dL).	Change from baseline Hemoglobin at Day 0, Day 31 and Day93.
Other	Hematocrit (Hct)	Collect blood and measure the value of Hematocrit (%).	Change from baseline Hematocrit at Day 0, Day 31 and Day93.
Other	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.
Other	Platelet	Collect blood and measure the value of Platelet (x 10^3/ul).	Change from baseline Platelet at Day 0, Day 31 and Day93.
Other	Mean corpuscular volume (MCV)	Collect blood and measure the value of MCV (fl).	Change from baseline MCV at Day 0, Day 31 and Day93.
Other	Mean corpuscular hemoglobin (MCH)	Collect blood and measure the value of MCH (pg).	Change from baseline MCH at Day 0, Day 31 and Day93.
Other	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.
Other	Mean platelet volume (MPV)	Collect blood and measure the value of MPV (fl).	Change from baseline MPV at Day 0, Day 31 and Day93.
Primary	Constitution in Chinese Medicine Questionnaire (CCMQ)		Change from baseline CCMQ at Day0, Day31, Day93 and Day180.
Primary	Serum Cytokines	Collect blood and measure the level of serum cytokines.	Change from baseline serum cytokines at Day0, Day31 and Day93.
Secondary	Tongue diagnosis	Use tongue photos for analysis	Change from baseline tongue diagnosis at Day0 and Day93.
Secondary	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.
Secondary	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.
Secondary	Genotype	Collect blood and analyze the genotype by microarray assay.	Change from baseline genotype at Day 0, Day 31 and Day93.