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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

Primary Purpose

Cold Hypersensitivity

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ucha-Shinki-Hwan
Placebo
Sponsored by
Gachon University Gil Oriental Medical Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cold Hypersensitivity focused on measuring Cold Hypersensitivity, Korean medicine, Ucha-Shinki-Hwan

Eligibility Criteria

19 Years - 59 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female subjects aged 19 to 59 years have a complaint of CHHF.
  • Patients must include at least one or more of the following symptoms:
  • Those who have the symptoms of CHH in normal temperature which most individuals feel no cold;
  • Those who have the symptoms of extremely cold hands in cold temperature exposure;
  • Those who are on the return to a warmer environment, the symptoms of cold hands is not completely rewarmed;
  • Those who have 4 cm or greater of VAS CHH score;
  • A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher than 0.3℃;
  • Those who can comply with all study-related procedures, medications, and evaluations;
  • Given a written informed consent form.

Exclusion Criteria:

  • Patients with calcium antagonists or beta-blockers with the purpose of treating CHH;
  • Those who have one or more finger gangrene or ulceration;
  • Those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs;
  • Those who are diagnosed by autoimmune disease or have a positive ANA test result;
  • Those who are diagnosed by carpal tunnel syndrome or have a positive Tinel and Phalen's tests;
  • Those who are diagnosed with cervical disc herniation or (malignant) tumor disease;
  • Those who are diagnosed with diabetes;
  • Those who are currently medicated to drugs that may affect to CHH symptoms, such as anticoagulants etc;
  • Those who have moderate level of liver dysfunction (each of AST, ALT greater than 100 IU/L) or kidney dysfunction (Cr 2.0mg/dL);
  • Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis, schizophrenia, or serious mental illness;
  • Those who are Diagnosed with moderate anemia and hematologic disorders (adult non-pregnant women hemoglobin (Hgb) level less than 7g/dL, hematocrit (Hct) level less than 26%, white blood cell (WBC) level greater than 11,000/mm3); Those whose systolic blood pressure (SBP) 180mmHg or diastolic blood pressure (DBP) is greater than 100 mmHg based on average value of at least 2 measurements;
  • Those who are suspected arrhythmia that showing up on ECG, or diagnosed by heart diseases, such as, ischemic heart disease and so on;
  • Those who are addicted to alcohol or drugs;
  • Those who are pregnant (positive urine-HCG) or lactating or have the chances of pregnancy;
  • Those who are diagnosed with malignant tumor
  • Those who are currently participated in other clinical trials;
  • Those who are able to understand and speak Korean;
  • Those who are judged to be inappropriate for the clinical study by the researchers.

Sites / Locations

  • Kyung Hee University medical center at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

UCHA group

Placebo group

Arm Description

2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Shinhwa Pharmaceutical company

2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Tsumura Co., Tokyo, Japan

Outcomes

Primary Outcome Measures

Changes from baseline in visual analogue scale(VAS)
The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.

Secondary Outcome Measures

Changes from baseline in body temperature
Changes from baseline in body temperature
Changes from baseline in WHO Quality of Life-BREF
It is a international cross-culturally comparable quality of life assessment instrument. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. There are also two items that are examined separately: Q1 asks about an individuals overall perception of QoL and Q2 asks about an individuals overall perception of their health. The four domain scores denote an individuals perception of QoL in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Meanscores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.
Changes from baseline in blood pressure
assess for monitoring patient safety
Changes from baseline in Pulse rate
assess for monitoring patient safety
Levels of AST
liver function test for monitoring patient safety(IU/L)
Levels of ALT
liver function test for monitoring patient safety(IU/L)
Levels of r-GTP
liver function test for monitoring patient safety(IU/L)
Levels of BUN
Kidney function test for monitoring patient safety(mmol/L)
Levels of Cr
Kidney function test for monitoring patient safety(mmol/L)
Adverse event

Full Information

First Posted
December 26, 2018
Last Updated
August 30, 2021
Sponsor
Gachon University Gil Oriental Medical Hospital
Collaborators
Kyunghee University Medical Center, Kyung Hee University Hospital at Gangdong, Semyung University Affiliated Oriental Medical Hospital, Sangji University Oriental Medical Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03790033
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 11, 2018 (Actual)
Primary Completion Date
August 14, 2019 (Actual)
Study Completion Date
September 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Oriental Medical Hospital
Collaborators
Kyunghee University Medical Center, Kyung Hee University Hospital at Gangdong, Semyung University Affiliated Oriental Medical Hospital, Sangji University Oriental Medical Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cold Hypersensitivity
Keywords
Cold Hypersensitivity, Korean medicine, Ucha-Shinki-Hwan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UCHA group
Arm Type
Experimental
Arm Description
2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Shinhwa Pharmaceutical company
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
2.5g, three times a day, each taken before or between meals for 8 weeks. Manufacturing company: Tsumura Co., Tokyo, Japan
Intervention Type
Drug
Intervention Name(s)
Ucha-Shinki-Hwan
Other Intervention Name(s)
Bosinji
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo granule
Primary Outcome Measure Information:
Title
Changes from baseline in visual analogue scale(VAS)
Description
The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels.
Time Frame
At baseline, week 4, 8, 12
Secondary Outcome Measure Information:
Title
Changes from baseline in body temperature
Description
Changes from baseline in body temperature
Time Frame
At baseline, week 4, 8, 12
Title
Changes from baseline in WHO Quality of Life-BREF
Description
It is a international cross-culturally comparable quality of life assessment instrument. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. There are also two items that are examined separately: Q1 asks about an individuals overall perception of QoL and Q2 asks about an individuals overall perception of their health. The four domain scores denote an individuals perception of QoL in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Meanscores are then multiplied by 4 in order to make domain scores comparable with the scores used in the WHOQOL-100.
Time Frame
At baseline, week 4, 8, 12
Title
Changes from baseline in blood pressure
Description
assess for monitoring patient safety
Time Frame
up to 12 weeks
Title
Changes from baseline in Pulse rate
Description
assess for monitoring patient safety
Time Frame
up to 12 weeks
Title
Levels of AST
Description
liver function test for monitoring patient safety(IU/L)
Time Frame
At screening visit, week 8
Title
Levels of ALT
Description
liver function test for monitoring patient safety(IU/L)
Time Frame
Kidney function test for monitoring patient safety(mmol/L)
Title
Levels of r-GTP
Description
liver function test for monitoring patient safety(IU/L)
Time Frame
Kidney function test for monitoring patient safety(mmol/L)
Title
Levels of BUN
Description
Kidney function test for monitoring patient safety(mmol/L)
Time Frame
Kidney function test for monitoring patient safety(mmol/L)
Title
Levels of Cr
Description
Kidney function test for monitoring patient safety(mmol/L)
Time Frame
Kidney function test for monitoring patient safety(mmol/L)
Title
Adverse event
Time Frame
At week 4, 8, 12
Other Pre-specified Outcome Measures:
Title
Pattern Identification Questionnaire
Description
This tool is a traditional medicine researcher self-developed questionnaire of screening for patients with Cold Hypersensitivity in the Hands and feet In this trial, we will assess the validity of the tool.
Time Frame
At screening visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female subjects aged 19 to 59 years have a complaint of CHHF. Patients must include at least one or more of the following symptoms: Those who have the symptoms of CHH in normal temperature which most individuals feel no cold; Those who have the symptoms of extremely cold hands in cold temperature exposure; Those who are on the return to a warmer environment, the symptoms of cold hands is not completely rewarmed; Those who have 4 cm or greater of VAS CHH score; A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher than 0.3℃; Those who can comply with all study-related procedures, medications, and evaluations; Given a written informed consent form. Exclusion Criteria: Patients with calcium antagonists or beta-blockers with the purpose of treating CHH; Those who have one or more finger gangrene or ulceration; Those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs; Those who are diagnosed by autoimmune disease or have a positive ANA test result; Those who are diagnosed by carpal tunnel syndrome or have a positive Tinel and Phalen's tests; Those who are diagnosed with cervical disc herniation or (malignant) tumor disease; Those who are diagnosed with diabetes; Those who are currently medicated to drugs that may affect to CHH symptoms, such as anticoagulants etc; Those who have moderate level of liver dysfunction (each of AST, ALT greater than 100 IU/L) or kidney dysfunction (Cr 2.0mg/dL); Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis, schizophrenia, or serious mental illness; Those who are Diagnosed with moderate anemia and hematologic disorders (adult non-pregnant women hemoglobin (Hgb) level less than 7g/dL, hematocrit (Hct) level less than 26%, white blood cell (WBC) level greater than 11,000/mm3); Those whose systolic blood pressure (SBP) 180mmHg or diastolic blood pressure (DBP) is greater than 100 mmHg based on average value of at least 2 measurements; Those who are suspected arrhythmia that showing up on ECG, or diagnosed by heart diseases, such as, ischemic heart disease and so on; Those who are addicted to alcohol or drugs; Those who are pregnant (positive urine-HCG) or lactating or have the chances of pregnancy; Those who are diagnosed with malignant tumor Those who are currently participated in other clinical trials; Those who are able to understand and speak Korean; Those who are judged to be inappropriate for the clinical study by the researchers.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chan Yong Jun
Organizational Affiliation
Gachon University Gil Oriental Medicine Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University medical center at Gangdong
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
not decided
Citations:
PubMed Identifier
32080084
Citation
Ko Y, Sun SH, Go HY, Lee JM, Jang JB, Sung HK, Jang BH, Jeon CY, Ko SG. Efficacy and safety of ucha-shinki-hwan on korean patients with cold hypersensitivity in the hands and feet: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Feb;99(8):e19110. doi: 10.1097/MD.0000000000019110.
Results Reference
derived

Learn more about this trial

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

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