Efficacy and Safety of Sipjeondaebo-tang on Korean Patients With Cold Hypersensitivity in the Hands and Feet (SDT)
NCT ID: NCT03374345
Last Updated: 2021-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2018-01-31
2019-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SDT group
3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
Sipjeondaebo-tang Granule
3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
Placebo group
3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
Placebo
3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
Interventions
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Sipjeondaebo-tang Granule
3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
Placebo
3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM \& FOODS Co. Ltd.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 diagnosed with malignant tumor
* 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.
19 Years
59 Years
FEMALE
No
Sponsors
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Kyunghee University Medical Center
OTHER
Kyung Hee University Hospital at Gangdong
OTHER
Semyung University Affiliated Oriental Medical Hospital
OTHER
Sangji University Oriental Medical Hospital
UNKNOWN
Gachon University Gil Oriental Medical Hospital
OTHER
Responsible Party
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Chan-Yong Jeon
Principle Investigator
Locations
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Gachon University Gil Hospital
Incheon, , South Korea
Countries
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References
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Ko Y, Sun SH, Han IS, Go HY, Kim TH, Lee JM, Jang JB, Park KS, Song YK, Lee KY, Jeon CY, Ko SG. The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial. Trials. 2019 Apr 15;20(1):217. doi: 10.1186/s13063-019-3286-7.
Other Identifiers
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ISEE_2017_SDT
Identifier Type: -
Identifier Source: org_study_id
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