Cold Hypersensitivity
Conditions
Keywords
Cold Hypersensitivity, Korean medicine, Ojeok-san, Cold intolerance
Brief summary
The Purpose of this trial is to investigate the efficacy and safety of Ojeok-san(OJS) on Korean Patients With Cold Hypersensitivity in the Hands
Interventions
DRUGOjeok-San
Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
DRUGPlacebo
Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
Sponsors
Chan-Yong Jeon
Kyunghee University Medical Center
Kyung Hee University Hospital at Gangdong
Semyung University Affiliated Oriental Medical Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 59 Years
Healthy volunteers
No
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
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 diagnosed with malignant tumor 17. Those who are currently participated in other clinical trials; 18. Those who are unable to understand and speak Korean; 19. Those who are judged to be inappropriate for the clinical study by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from baseline in visual analogue scale | At baseline, week 4, 8, 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in body temperature | At baseline, week 4, 8, 12 | — |
| Changes from baseline in WHOQoL-BREF | At baseline, week 4, 8, 12 | — |
| Changes from baseline in cold stress test | At baseline, week 8 | similar to the cold stimulation test |
| Vital Sign | every visit | Body temperature, blood pressure, pulse rate |
| complete blood count | At screening visit, week 8 | — |
| Adverse event | At week 4, 8, 12 | — |
| Liver function tests | At screening visit, week 8 | Levels of AST, ALT and r-GTP |
| Kidney function test | At screening visit, week 8 | Levels of BUN and Cr |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pattern Identification Questionnaire | At screening visit | This questionnaire is a traditional medicine researcher self-developed questionnaire for collecting general symptoms of patients with Cold Hypersensitivity in the Hands and feet |
| Cold Hypersensitivity diagnostic tool | At screening visit | 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. |
Countries
South Korea
Outcome results
None listed