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Table 3 Participant withdrawal criteria of the Sipjeondaebo-tang study

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

Participant withdrawal criterion

1. Those whose medication compliance is < 70%

2. Those who become pregnant during the study period

3. Those who need surgery or inpatient treatment due to emergencies such as accidents or other illnesses

4. Subject’s withdrawal of consent

5. Subjects who have received prohibited medicines or therapies (e.g., anticoagulants, psychotropic drugs, and other drugs that may affect the symptoms of CHHF)

6. Those who need standard treatment due to deterioration of symptoms of CHHF

7. Occurrence of a serious adverse event

8. Occurrence of factors making it difficult to sustain the process or investigator’s decision to terminate because of clinical trial results affected by some factors

  1. CHHF cold hypersensitivity in the hands and feet