Clinical trial NCT03083522: Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet
Official title: Efficacy and Safety of Ojeok-san on Korean Patients With Cold Hypersensitivity in the Hands and Feet - A Randomized, Double-blinded, Placebo Controlled, Multi-center Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cold Hypersensitivity
Keywords: Cold Hypersensitivity
Korean medicine
Ojeok-san
Cold intolerance
Lead sponsor: Gachon University Gil Oriental Medical Hospital
Sponsor class: OTHER
Collaborators: name: Kyunghee University Medical Center
name: Kyung Hee University Hospital at Gangdong
name: Semyung University Affiliated Oriental Medical Hospital
First posted: 2017-03-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

1. Female subjects aged 19 to 59 years have a complaint of CHH.
2. 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;
3. Those who have 4 cm or greater of VAS CHH score;
4. A thermal differences between the palm (PC8) and the upper arm (LU4) may be higher than 0.3℃;
5. Those who can comply with all study-related procedures, medications, and evaluations;
6. Given a written informed consent form.

Exclusion Criteria:

1. Patients with calcium antagonists or beta-blockers with the purpose of treating CHH;
2. Those who have one or more finger gangrene or ulceration;
3. Those who are diagnosed by hypothyroidism or currently medicated to thyroid drugs;
4. Those who are diagnosed by autoimmune disease or have a positive ANA test result;
5. Those who are diagnosed by carpal tunnel syndrome or have a positive Tinel and Phalen's tests;
6. Those who are diagnosed with cervical disc herniation or (malignant) tumor disease;
7. Those who are diagnosed with diabetes;
8. Those who are currently medicated to drugs that may affect to CHH symptoms, such as anticoagulants etc;
9. Those who have moderate level of liver dysfunction (each of AST, ALT greater than 100 IU/L) or kidney dysfunction (Cr 2.0mg/dL);
10. 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;
11. 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);
12. 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;
13. Those who are suspected arrhythmia that showing up on ECG, or diagnosed by heart diseases, such as, ischemic heart disease and so on;
14. Those who are addicted to alcohol or drugs;
15. Those who are pregnant (positive urine-HCG) or lactating or have the chances of pregnancy;
16. Those who are diagnosed with malignant tumor
17. Those who are currently participated in other clinical trials;
18. Those who are unable to understand and speak Korean;
19. Those who are judged to be inappropriate for the clinical study by the researchers.

Primary outcomes:
measure: Changes from baseline in visual analogue scale
timeFrame: At baseline, week 4, 8, 12
Secondary outcomes:
measure: Changes from baseline in body temperature
timeFrame: At baseline, week 4, 8, 12
measure: Changes from baseline in WHOQoL-BREF
timeFrame: At baseline, week 4, 8, 12
measure: Changes from baseline in cold stress test
timeFrame: At baseline, week 8
measure: Vital Sign
timeFrame: every visit
measure: Liver function tests
timeFrame: At screening visit, week 8
measure: Kidney function test
timeFrame: At screening visit, week 8
measure: complete blood count
timeFrame: At screening visit, week 8
measure: Adverse event
timeFrame: At week 4, 8, 12
Other outcomes:
measure: Pattern Identification Questionnaire
timeFrame: At screening visit
measure: Cold Hypersensitivity diagnostic tool
timeFrame: At screening visit
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee university medical center
Study officials:
affiliation: Gachon University Gil Oriental Medical Hospital
name: Chanyong Jeon, PhD
role: STUDY_CHAIR
References:
citation: Ko Y, Go HY, Han IS, Lee KY, Kim TH, Lee JM, Jang JB, Song YK, Sun SH, Jeon CY, Ko SG. Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study. Trials. 2018 Nov 29;19(1):662. doi: 10.1186/s13063-018-3013-9.