Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands
Phase 4
Completed
- Conditions
- Cold Hypersensitivity
- Interventions
- Drug: Danggui-Sayuk-Ga-Osuyu-Saenggang-tang
- Registration Number
- NCT02645916
- Lead Sponsor
- Gachon University Gil Oriental Medical Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 66
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DSGOST Danggui-Sayuk-Ga-Osuyu-Saenggang-tang admission to Danggui-Sayuk-Ga-Osuyu-Saenggang-tang granule
- Primary Outcome Measures
Name Time Method Changes from baseline in visual analogue scale At baseline, week 2, 4, 6
- Secondary Outcome Measures
Name Time Method Changes from baseline in clinical global impression(CGI) At baseline, week 2, 4, 6 Changes from baseline in cold stress test At baseline, week 6 similar to the cold stimulation test
Changes from baseline in body temperature At baseline, week 2, 4, 6 Changes from baseline in WHOQoL-BREF At baseline, week 2, 4, 6
Trial Locations
- Locations (1)
Gachon University, Gil Oriental Medicine Center
🇰🇷Incheon, Korea, Republic of