Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hand… (NCT03790033) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy and Safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet-Double Blinded, Randomized, Multicenter, Placebo Controlled Clinical Trial
South Korea164 participantsStarted 2018-12-11
Plain-language summary
To investigate the efficacy and safety of Ucha-Shinki-Hwan on Korean Patients With Cold Hypersensitivity in the Hands and Feet
Who can participate
Age range
19 Years – 59 Years
Sex
FEMALE
See this in plain English?
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 CHHF.
* 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 dysfu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes from baseline in visual analogue scale(VAS)
Timeframe: At baseline, week 4, 8, 12
Trial details
NCT IDNCT03790033
SponsorGachon University Gil Oriental Medical Hospital