Official Title

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

    Phase 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    66
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
Study Started
Dec 31
2015
Primary Completion
Aug 01
2017
Study Completion
Aug 01
2017
Last Update
Nov 29
2017

Drug Danggui-Sayuk-Ga-Osuyu-Saenggang-tang

Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.

  • Other names: DSGOST, Dangsanin Granule

Drug Placebo: corn starch

Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.

DSGOST Experimental

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

Placebo Placebo Comparator

admission to placebo

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.
No Results Posted