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Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet-Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial

NCT03790033 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2021-09-01

No results posted yet for this study

Summary

To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet

Conditions

  • Cold Hypersensitivity

Interventions

DRUG

Ucha-Shinki-Hwan

Product name : Bosinji Granule Manufacturer : Tsumura \& Co. Ingredient : Bosinji granule 2.5g (Bosinji extract 1.523g) Bosinji extract is composed of following proportion of ingredient Rehmannia Root 1.7g Achyranthes Root 1.0g Cornus Fruit 1.0g Dioscorea Rhizome 1.0g Psyllium Husk 1.0g Alisma Rhizome 1.0g Hoelen 1.0g Moutan Root Bark 1.0g Cinnamon Bark 0.3g Pulvis Aconiti Tuberis Purificatum 0.3g

DRUG

Placebo

placebo granule

Sponsors & Collaborators

  • Kyunghee University Medical Center

    collaborator OTHER

  • Kyung Hee University Hospital at Gangdong

    collaborator OTHER

  • Semyung University Affiliated Oriental Medical Hospital

    collaborator OTHER

  • Sangji University Oriental Medical Hospital

    collaborator UNKNOWN

  • Gachon University Gil Oriental Medical Hospital

    lead OTHER

Principal Investigators

  • Chan Yong Jun · Gachon University Gil Oriental Medicine Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
59 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2019-08-14
Completion
2019-09-14

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03790033 on ClinicalTrials.gov