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

Gachon University Gil Oriental Medical Hospital

Status and phase: Completed; Phase 4

Conditions: Cold Hypersensitivity

Treatments: Drug: Danggui-Sayuk-Ga-Osuyu-Saenggang-tang; Drug: Placebo: corn starch

Study type: Interventional

Funder types: Other

Identifiers

NCT02645916

ISEE_2015_DSGOST

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: Female

Ages: 19 to 59 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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66 participants in 2 patient groups, including a placebo group

DSGOST

Experimental group

Description:

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

Treatment:

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

Placebo

Placebo Comparator group

Description:

admission to placebo

Treatment:

Drug: Placebo: corn starch