KCT0003723
Recruiting
未知
A Double-blind, Randomized, Placebo-controlled, pararell, Multicenter clinical Study of the efficacy and safety of the Ongyeong-tang(OKT) for Coldness of Feet(Cold Hypersensitivity in Feet)
Sangji University Oriental Medical Center0 sites112 target enrollmentTBD
ConditionsNot Applicable
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not Applicable
- Sponsor
- Sangji University Oriental Medical Center
- Enrollment
- 112
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female aged 19 to 59 years have a complaint of cold hypersensitivity on hands and feet
- •2\. Subject must include at least one or more of the following symptoms below:
- •Subject has the symptoms of cold hands and feet in normal temperature which most individuals feel no cold
- •Subject has the symptoms of severe cold hands and feet in colder than normal temperature exposure
- •Even subject is on the return to a warmer environment, the symptoms of cold hands and feet is not completely
- •disappeared
- •3\. When subject's VAS(Visual Analogue Scale) of cold hypersensitivity on feet VAS) is 4 or more
- •4\. When subject's both upper arms exposure to room temperature (24?±2\), the thermal deviation between the foot (acupuncture point, LR3\) with the thigh(acupuncture point, S32\) may be higher than 2?
- •5\. Ability to comply with all study\-related procedures, medications, and evaluations
- •6\. Ability to give informed consent
Exclusion Criteria
- •\- Patients who are admission to calcium antagonists and beta\-blockers as a treatment of cold hypersensitivity on hands
- •\- Patients who are having one or more finger gangrene or ulceration
- •\- Patients who are diagnosed by hyperthyroidism or currently medicated to thyroid drugs
- •\- Patients who are diagnosed by Autoimmune disease or having a positive antinuclear antibody(ANA) test
- •\- Patients who are diagnosed by Carpal Tunnel Syndrome or having a positive Tinel's sign and Phalen's tests
- •\- Patients who are diagnosed with Cervical disc herniation
- •\- Patients who are diagnosed with diabetes
- •\- Drug that may affect to the cold hypersensitivity on hands and feet(ex. anticoagulants)
- •\- Moderate level of liver dysfunction(each of AST, ALT greater than 100 IU/L) or kidney dysfunction patient(creatine 2\.0mg/dL)
- •\- Due to the behaviour disorder or depression or anxiety neurosis or schizophrenia or serious mental illness, do not cooperate with treatment and follow up
Outcomes
Primary Outcomes
Not specified
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