CompletedPhase 3

Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet

South Korea60 participantsStarted 2017-03-30

Plain-language summary

The Purpose of this trial is to investigate the efficacy and safety of Ojeok-san(OJS) on Korean Patients With Cold Hypersensitivity in the Hands

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.

✓. 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.

✕. 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;

Changes from baseline in visual analogue scale

Timeframe: At baseline, week 4, 8, 12

NCT IDNCT03083522

SponsorChan-Yong Jeon

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-14