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Completed

NCT Number: NCT04974073

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.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

China Medical University Hospital

Taichung, 404, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PHY606

Drug

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

Other names: Danggui Buxue Tang

Primary outcomes

  1. Constitution in Chinese Medicine Questionnaire (CCMQ)

    Time frame: Change from baseline CCMQ at Day0, Day31, Day93 and Day180.

  2. Serum Cytokines

    Time frame: Change from baseline serum cytokines at Day0, Day31 and Day93.

    Collect blood and measure the level of serum cytokines.

Secondary outcomes

  1. Tongue diagnosis

    Time frame: Change from baseline tongue diagnosis at Day0 and Day93.

    Use tongue photos for analysis

  2. Pulse diagnosis

    Time frame: Change from baseline Pulse diagnosis at Day0 and Day93.

    Use the pulse detector to detect the rhythm data of the subject's left and right hand pulse.

  3. Anemia blood test

    Time frame: Change from baseline anemia blood at Day 0, Day 31 and Day93.

    Collect blood and measure the level of ferritin(ng/mL), TIBC(ug/dL), transferrin(mg/dL).

  4. Genotype

    Time frame: Change from baseline genotype at Day 0, Day 31 and Day93.

    Collect blood and analyze the genotype by microarray assay.

Other outcomes

  1. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)

    Time frame: Change from baseline FACIT-F score at Day0, Day31, Day93 and Day180.

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from baseline PSQI score at Day0, Day31, Day93 and Day180.

  3. 36-Item Short Form Health Survey (SF-36)

    Time frame: Change from baseline SF-36 score at Day0, Day31, Day93 and Day180.

  4. White blood cell (WBC)

    Time frame: Change from baseline WBC at Day 0, Day 31 and Day93.

    Collect blood and measure the value of WBC (x 10^3/ul).

  5. Red Blood Cells (RBC)

    Time frame: Change from baseline RBC at Day 0, Day 31 and Day93.

    Collect blood and measure the value of RBC (x 10^6/ul).

  6. Hemoglobin (Hb)

    Time frame: Change from baseline Hemoglobin at Day 0, Day 31 and Day93.

    Collect blood and measure the value of Hemoglobin (gm/dL).

  7. Hematocrit (Hct)

    Time frame: Change from baseline Hematocrit at Day 0, Day 31 and Day93.

    Collect blood and measure the value of Hematocrit (%).

  8. Red blood cell volume distribution width (RDW)

    Time frame: Change from baseline RDW at Day 0, Day 31 and Day93.

    Collect blood and measure the value of RDW (%).

  9. Platelet

    Time frame: Change from baseline Platelet at Day 0, Day 31 and Day93.

    Collect blood and measure the value of Platelet (x 10^3/ul).

  10. Mean corpuscular volume (MCV)

    Time frame: Change from baseline MCV at Day 0, Day 31 and Day93.

    Collect blood and measure the value of MCV (fl).

  11. Mean corpuscular hemoglobin (MCH)

    Time frame: Change from baseline MCH at Day 0, Day 31 and Day93.

    Collect blood and measure the value of MCH (pg).

  12. Mean corpuscular hemoglobin concentration (MCHC)

    Time frame: Change from baseline MCHC at Day 0, Day 31 and Day93.

    Collect blood and measure the value of MCHC (g/dL).

  13. Mean platelet volume (MPV)

    Time frame: Change from baseline MPV at Day 0, Day 31 and Day93.

    Collect blood and measure the value of MPV (fl).

Sponsors and collaborators

Lead sponsor

Sheng-Teng Huang

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Jul 23, 2021
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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