Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hyperse… (NCT02645916) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean Patients With Cold Hypersensitivity in the Hands
South Korea66 participantsStarted 2015-12
Plain-language summary
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
Who can participate
Age range19 Years – 59 Years
SexFEMALE
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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 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;
✕
What they're measuring
1
Changes from baseline in visual analogue scale
Timeframe: At baseline, week 2, 4, 6
Trial details
NCT IDNCT02645916
SponsorGachon University Gil Oriental Medical Hospital