Efficacy and safety of the Chinese herbal formula Hewei Jiangni recipe for NERD with cold-heat complex syndrome: study protocol for a double-blinded randomized controlled trial

Table 5 Adverse drug reaction supervision center of the Ministry of Health. Evaluation criteria for the relationship between AE and research drug use

Judgment index	Judgment result
Judgment index	Definitely	Probably	Probably	Suspiciously	Impossible
1. Whether there is a reasonable relationship between the time of starting medication and the time of suspicious occurrence.	+	+	+	+	+
2. Whether the suspected ADR (ADR) conforms to the known ADR type of the drug	+	+	+	−	−
3. Whether the suspected ADR can be explained by the patient's pathological condition, combined medication, therapy or previous therapy.	−	−	±	±	+
4. It is doubtful whether the withdrawal or reduced dose of ADR alleviates or disappears	+	+	±	±	−
5. Does the same reaction occur again after re-exposure to suspicious drugs	+	?	?	?	-

Description: + for positive, − for negative, ± for positive or negative, ? indicates that the situation is unknown

ISSN: 1745-6215