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Table 2 Exclusion criteria for the Onkyeong-tang (OKT) clinical trial

From: Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study

Exclusion criteria

1. Those who are taking calcium antagonists or beta-blockers as a treatment for CHHF

2. Those who are experiencing gangrene or ulceration in one or more fingers

3. Those who are diagnosed with hyperthyroidism or are currently medicated with thyroid drugs

4. Those who are diagnosed with autoimmune disease(s)

5. Those who are diagnosed as having tarsal tunnel syndrome or a positive Tinel’s sign and Phalen’s test

6. Those who are diagnosed with cervical disc herniation

7. Those who are diagnosed with diabetes

8. Those who are taking a drug that may influence CHF (e.g., anticoagulants)

9. Those with a moderate level of liver dysfunction (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] levels both greater than 100 IU/L) or kidney dysfunction (creatinine [Cr] level greater than 2 mg/dL)

10. Those unable to give informed consent

11. Non-pregnant adult women with hemoglobin (Hb) level less than 7 g/dL, hematocrit level less than 26%, and white blood cell (WBC) count greater than 11,000/mm3

12. Those whose average systolic blood pressure (SBP) is 180 mmHg or more or whose diastolic blood pressure (DBP) is 100 mmHg or more when measured twice

13. Those with suspected arrhythmia, as shown with an electrocardiogram (ECG), or those diagnosed with heart disease, such as ischemic heart disease

14. Those who are addicted to alcohol or drugs

15. Those who are pregnant (positive urine human chorionic gonadotropin [hCG]), lactating, or planning for pregnancy

16. Those diagnosed with malignant tumors

17. Those taking part in other clinical trials

18. Those who are unable to understand or speak Korean

19. Those who are judged to be unfit for the clinical trial by the researchers