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Table 2 Eligible criteria

From: 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

Inclusion criteria

1. Female participants aged 19 to 59 years who complain of cold hypersensitivity in the hands and feet (CHHF)

2. Patients must have at least one of the following symptoms:

 (a) Symptoms of CHHF at a temperature at which most individuals feel no cold

 (b) Symptoms of extremely cold hands and feet upon exposure to cold

 (c) Continuance of symptoms of cold hands upon return to a warmer environment

3. Those with a CHHF Visual Analog Scale (VAS) score of 4 or higher

4. Those for whom the temperature of the palm (PC8) is lower than that of the upper arm (LU4) by 0.3 °C or more

5. Those who can comply with all study-related procedures, medications, and evaluations

6. Those who have completed a written informed consent form

Exclusion criteria

1. Those taking calcium antagonists or beta-blockers for the purpose of treating CHHF

2. Those with one or more ulcers or gangrene of the finger

3. Those who have been diagnosed with hypothyroidism or are taking thyroid-related medication

4. Those who are diagnosed with an autoimmune disease

5. Those who are diagnosed with carpal tunnel syndrome or have a positive result in Tinel and Phalen’s tests

6. Those who have been diagnosed with cervical disk herniation

7. Those who have been diagnosed with diabetes

8. Those who are currently medicated with drugs that may affect CHHF symptoms, such as anticoagulants

9. Those who have serious liver dysfunction (AST and ALT, each 100 IU/L or more) or renal dysfunction (creatinine (Cr) 2.0 mg/dL or more)

10. Those who do not (cannot) comply with treatment and follow-up due to 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 (Hb) level less than 7 g/dL, hematocrit (Hct) level less than 26%, white blood cell (WBC) level 11,000/mm3 or more)

12. Those with systolic blood pressure (SBP) 180 mmHg or diastolic blood pressure (DBP) greater than 100 mmHg based on average value of at least 2 measurements

13. Those who have suspected arrhythmia requiring treatment on EKG, or have been diagnosed with heart diseases, such as, ischemic heart disease and so on

14. Those who are addicted to alcohol or drugs

15. Fertile women who are pregnant (positive urine-HCG), have a pregnancy plan, or do not agree to the appropriate method of contraception

16, Those who have been diagnosed with a malignant tumor

17. Those who are currently participating 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