Development of PHY606 as Adjunct Therapy for Anemia Patients

NCT04974073 | Completed Phase 3

• 1 other identifier: CMUH106-REC3-028
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Herbal Interaction

Keywords

Anemia; Danggui Buxue Tang; PHY606; Side effects; TCM

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Tongue diagnosis

  Change from baseline tongue diagnosis at Day0 and Day93.

• Pulse diagnosis

  Change from baseline Pulse diagnosis at Day0 and Day93.

• Anemia blood test

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

• Genotype

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

Other Outcomes (13)

• 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.

Study Arms (3)

control group

NO INTERVENTION

with traditional western medicine treatment based on underlined disease

PHY606

EXPERIMENTAL

PHY606 7.5gm BID for 3 months

Drug: PHY606

Healthy group

OTHER

PHY606 7.5gm BID for 2 days

Drug: PHY606

Interventions

PHY606 DRUG

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

Also known as: Danggui Buxue Tang

Healthy group; PHY606

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female: Hb\<11 g/dL; male: Hb\<13.5 g/dL
• has no allergic reaction to TCM

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheng-Teng Huang: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Anemia

Interventions

danggui buxue decoction

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Sheng-Teng Huang, MD PHD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 23, 2021
• Study Start: August 22, 2017
• Primary Completion: August 22, 2017
• Study Completion: November 18, 2019
• Last Updated: August 16, 2021

Record last verified: 2021-08

Locations

TW (1)