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Development of PHY606 as Adjunct Therapy for Anemia Patients

Primary Purpose

Anemia, Herbal Interaction

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
PHY606
Sponsored by
Sheng-Teng Huang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anemia focused on measuring Anemia, Danggui Buxue Tang, PHY606, Side effects, TCM

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Other

Arm Label

control group

PHY606

Healthy group

Arm Description

with traditional western medicine treatment based on underlined disease

PHY606 7.5gm BID for 3 months

PHY606 7.5gm BID for 2 days

Outcomes

Primary Outcome Measures

Constitution in Chinese Medicine Questionnaire (CCMQ)
Serum Cytokines
Collect blood and measure the level of serum cytokines.

Secondary Outcome Measures

Tongue diagnosis
Use tongue photos for analysis
Pulse diagnosis
Use the pulse detector to detect the rhythm data of the subject's left and right hand pulse.
Anemia blood test
Collect blood and measure the level of ferritin(ng/mL), TIBC(ug/dL), transferrin(mg/dL).
Genotype
Collect blood and analyze the genotype by microarray assay.

Full Information

First Posted
July 1, 2021
Last Updated
August 10, 2021
Sponsor
Sheng-Teng Huang
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1. Study Identification

Unique Protocol Identification Number
NCT04974073
Brief Title
Development of PHY606 as Adjunct Therapy for Anemia Patients
Official Title
Development of PHY606 as Adjunct Therapy for Anemia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 22, 2017 (Actual)
Primary Completion Date
August 22, 2017 (Actual)
Study Completion Date
November 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sheng-Teng Huang

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Herbal Interaction
Keywords
Anemia, Danggui Buxue Tang, PHY606, Side effects, TCM

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
with traditional western medicine treatment based on underlined disease
Arm Title
PHY606
Arm Type
Experimental
Arm Description
PHY606 7.5gm BID for 3 months
Arm Title
Healthy group
Arm Type
Other
Arm Description
PHY606 7.5gm BID for 2 days
Intervention Type
Drug
Intervention Name(s)
PHY606
Other Intervention Name(s)
Danggui Buxue Tang
Intervention Description
Danggui Buxue Tang is a well-known TCM formula indicated for anemia through immune modulation and increase energy metabolism
Primary Outcome Measure Information:
Title
Constitution in Chinese Medicine Questionnaire (CCMQ)
Time Frame
Change from baseline CCMQ at Day0, Day31, Day93 and Day180.
Title
Serum Cytokines
Description
Collect blood and measure the level of serum cytokines.
Time Frame
Change from baseline serum cytokines at Day0, Day31 and Day93.
Secondary Outcome Measure Information:
Title
Tongue diagnosis
Description
Use tongue photos for analysis
Time Frame
Change from baseline tongue diagnosis at Day0 and Day93.
Title
Pulse diagnosis
Description
Use the pulse detector to detect the rhythm data of the subject's left and right hand pulse.
Time Frame
Change from baseline Pulse diagnosis at Day0 and Day93.
Title
Anemia blood test
Description
Collect blood and measure the level of ferritin(ng/mL), TIBC(ug/dL), transferrin(mg/dL).
Time Frame
Change from baseline anemia blood at Day 0, Day 31 and Day93.
Title
Genotype
Description
Collect blood and analyze the genotype by microarray assay.
Time Frame
Change from baseline genotype at Day 0, Day 31 and Day93.
Other Pre-specified Outcome Measures:
Title
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Time Frame
Change from baseline FACIT-F score at Day0, Day31, Day93 and Day180.
Title
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Change from baseline PSQI score at Day0, Day31, Day93 and Day180.
Title
36-Item Short Form Health Survey (SF-36)
Time Frame
Change from baseline SF-36 score at Day0, Day31, Day93 and Day180.
Title
White blood cell (WBC)
Description
Collect blood and measure the value of WBC (x 10^3/ul).
Time Frame
Change from baseline WBC at Day 0, Day 31 and Day93.
Title
Red Blood Cells (RBC)
Description
Collect blood and measure the value of RBC (x 10^6/ul).
Time Frame
Change from baseline RBC at Day 0, Day 31 and Day93.
Title
Hemoglobin (Hb)
Description
Collect blood and measure the value of Hemoglobin (gm/dL).
Time Frame
Change from baseline Hemoglobin at Day 0, Day 31 and Day93.
Title
Hematocrit (Hct)
Description
Collect blood and measure the value of Hematocrit (%).
Time Frame
Change from baseline Hematocrit at Day 0, Day 31 and Day93.
Title
Red blood cell volume distribution width (RDW)
Description
Collect blood and measure the value of RDW (%).
Time Frame
Change from baseline RDW at Day 0, Day 31 and Day93.
Title
Platelet
Description
Collect blood and measure the value of Platelet (x 10^3/ul).
Time Frame
Change from baseline Platelet at Day 0, Day 31 and Day93.
Title
Mean corpuscular volume (MCV)
Description
Collect blood and measure the value of MCV (fl).
Time Frame
Change from baseline MCV at Day 0, Day 31 and Day93.
Title
Mean corpuscular hemoglobin (MCH)
Description
Collect blood and measure the value of MCH (pg).
Time Frame
Change from baseline MCH at Day 0, Day 31 and Day93.
Title
Mean corpuscular hemoglobin concentration (MCHC)
Description
Collect blood and measure the value of MCHC (g/dL).
Time Frame
Change from baseline MCHC at Day 0, Day 31 and Day93.
Title
Mean platelet volume (MPV)
Description
Collect blood and measure the value of MPV (fl).
Time Frame
Change from baseline MPV at Day 0, Day 31 and Day93.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng-Teng Huang, MD PHD
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Development of PHY606 as Adjunct Therapy for Anemia Patients

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