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Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands

Primary Purpose

Cold Hypersensitivity

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Danggui-Sayuk-Ga-Osuyu-Saenggang-tang
Placebo: corn starch
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 in the Hands, Korean medicine, DSGOST

Eligibility Criteria

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

Inclusion Criteria:

  1. Female subjects aged 19 to 59 years have a complaint of CHH.

  2. 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;
  3. Those who have 4 cm or greater of VAS CHH score;
  4. A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher than 0.3℃;
  5. Those who can comply with all study-related procedures, medications, and evaluations;
  6. Given a written informed consent form.

Exclusion Criteria:

We will exclude patients who have taken

  1. Patients with calcium antagonists or beta-blockers with the purpose of treating CHH;
  2. Those who have one or more finger gangrene or ulceration;
  3. Those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs;
  4. Those who are diagnosed by autoimmune disease or have a positive ANA test result;
  5. Those who are diagnosed by carpal tunnel syndrome or have a positive Tinel and Phalen's tests;
  6. Those who are diagnosed with cervical disc herniation or (malignant) tumor disease;
  7. Those who are diagnosed with diabetes;
  8. Those who are currently medicated to drugs that may affect to CHH symptoms, such as anticoagulants etc;
  9. Those who have moderate level of liver dysfunction (each of AST, ALT greater than 100 IU/L) or kidney dysfunction (Cr 2.0mg/dL);
  10. 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;
  11. 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);
  12. 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;
  13. Those who are suspected arrhythmia that showing up on ECG, or diagnosed by heart diseases, such as, ischemic heart disease and so on;
  14. Those who are addicted to alcohol or drugs;
  15. Those who are pregnant (positive urine-HCG) or lactating or have the chances of pregnancy;
  16. Those who are currently participated in other clinical trials;
  17. Those who are able to understand and speak Korean;
  18. Those who are judged to be inappropriate for the clinical study by the researchers.

Sites / Locations

  • Gachon University, Gil Oriental Medicine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DSGOST

Placebo

Arm Description

admission to Danggui-Sayuk-Ga-Osuyu-Saenggang-tang granule

admission to placebo

Outcomes

Primary Outcome Measures

Changes from baseline in visual analogue scale

Secondary Outcome Measures

Changes from baseline in body temperature
Changes from baseline in clinical global impression(CGI)
Changes from baseline in WHOQoL-BREF
Changes from baseline in cold stress test
similar to the cold stimulation test

Full Information

First Posted
December 30, 2015
Last Updated
November 27, 2017
Sponsor
Gachon University Gil Oriental Medical Hospital
Collaborators
Sangji University Oriental Medical Hospital, Semyung University Affiliated Oriental Medical Hospital, Kyunghee University Medical Center, Kyung Hee University Hospital at Gangdong, DongGuk University
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1. Study Identification

Unique Protocol Identification Number
NCT02645916
Brief Title
Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands
Official Title
Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
August 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The Purpose of this trial is to investigate the efficacy and safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang(DSGOST) on Korean Patients With Cold Hypersensitivity in the Hands

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cold Hypersensitivity
Keywords
Cold Hypersensitivity in the Hands, Korean medicine, DSGOST

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DSGOST
Arm Type
Experimental
Arm Description
admission to Danggui-Sayuk-Ga-Osuyu-Saenggang-tang granule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
admission to placebo
Intervention Type
Drug
Intervention Name(s)
Danggui-Sayuk-Ga-Osuyu-Saenggang-tang
Other Intervention Name(s)
DSGOST, Dangsanin Granule
Intervention Description
Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Intervention Type
Drug
Intervention Name(s)
Placebo: corn starch
Intervention Description
Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Primary Outcome Measure Information:
Title
Changes from baseline in visual analogue scale
Time Frame
At baseline, week 2, 4, 6
Secondary Outcome Measure Information:
Title
Changes from baseline in body temperature
Time Frame
At baseline, week 2, 4, 6
Title
Changes from baseline in clinical global impression(CGI)
Time Frame
At baseline, week 2, 4, 6
Title
Changes from baseline in WHOQoL-BREF
Time Frame
At baseline, week 2, 4, 6
Title
Changes from baseline in cold stress test
Description
similar to the cold stimulation test
Time Frame
At baseline, week 6

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 CHH. 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: We will exclude patients who have taken 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 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.
Facility Information:
Facility Name
Gachon University, Gil Oriental Medicine Center
City
Incheon
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28595610
Citation
Ko Y, Go HY, Cho YY, Shin JH, Kim TH, Choi DJ, Lee JM, Jang JB, Song YK, Ko SG, Sun SH, Jeon CY. The efficacy and safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean patients with cold hypersensitivity in the hands: study protocol for a pilot, double-blind, randomized, placebo-controlled, parallel-group clinical trial. Trials. 2017 Jun 8;18(1):268. doi: 10.1186/s13063-017-2002-8.
Results Reference
derived

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Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands

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