Efficacy and Safety of Sipjeondaebo-tang on Korean Patients With Cold Hypersensitivity in the Han… (NCT03374345) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy and Safety of Sipjeondaebo-tang on Korean Patients With Cold Hypersensitivity in the Hands and Feet (SDT)
South Korea60 participantsStarted 2018-01-31
Plain-language summary
Gachon University, Gil Oriental Medicine Center
Who can participate
Age range19 Years – 59 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* 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 dysfun…
What they're measuring
1
Changes from baseline in visual analogue scale(VAS)
Timeframe: At baseline, week 4, 8, 12
Trial details
NCT IDNCT03374345
SponsorGachon University Gil Oriental Medical Hospital