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Table 2 Exclusion criteria of the trial

From: The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial

Exclusion criterion

1. Patients receiving beta-blockers or calcium antagonists for the purpose of treatment of CHHF

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

3. Those who have been diagnosed with hypothyroidism or prescribed thyroid medications

4. Those who have been diagnosed with autoimmune diseases

5. Those who have been diagnosed with carpal tunnel syndrome or have positive results on Phalen’s and Tinel’s tests

6. Those who have been diagnosed with cervical disc herniation

7. Those who have been diagnosed with diabetes mellitus

8. Those receiving medicines that can affect the symptoms of CHHF, such as anticoagulants

9. Those who present with CHHF due to postpartum or menopausal syndrome

10. Those who present with a moderate level of liver dysfunction (AST and ALT levels of > 100 IU/L) or kidney dysfunction (creatinine level of > 2.0 mg/dl)

11. Those who have behavior disorder, depression, anxiety, neurosis, or any other severe mental disorder

12. Adult nonpregnant women with a hemoglobin level of < 7 g/dl and WBC count of > 11 cells × 109 L

13. Those whose mean SBP is ≥ 180 mmHg or DBP is ≥ 100 mmHg when measured twice

14. Patients with an arrhythmia as determined by an electrocardiogram and requiring treatment, or with heart disease such as ischemic heart disease

15. Alcohol or drug abusers

16. Women who are pregnant (urine hCG positive), lactating women, and fertile women who have a pregnancy plan or do not consent to the proper method of contraception

17. Those who have been diagnosed with a malignant tumor

18. Those who are participating in other clinical trials

19. Those who refuse to participate in clinical trials or provide written informed consent

20. Those who cannot understand or speak Korean

21. Those who are judged to be inappropriate for clinical trials by the researchers

  1. ALT alanine aminotransferase, AST aspartate aminotransferase, CHHF cold hypersensitivity in the hands and feet, DBP diastolic blood pressure, hCG human chorionic gonadotropin, SBP systolic blood pressure, WBC white blood cell