Abstract:
Digas colic drops (DCD-684) a polyherbal formulation containing Carum carvi, Foeniculum vulgare, Mentha
arvensis, Mentha piperita and Zingiber officinale is widely used in Pakistan against gastrointestinal ailments including
infantile colic. The DCD-684 (0.03-3ml/kg.bw) administered orally in acute (7-days) and sub-acute toxicity (14-days)
tests, displayed neither mortality nor toxicological changes in physical, behavioral, biochemical and histopathological
parameters. In chronic study (90-days), DCD-684 (0.3-12 ml/kg.bw) also revealed no changes. However, at 18 and 36
ml/kg.bw, liver demonstrated mild inflammation correlating with raised aspartate transaminase (AST), alkaline
phosphatase (ALP) and alpha fetoprotein (AFP) levels. Increased levels of urea and inflamed renal parenchyma indicated
mild nephro-toxicity with high alanine aminotransferase (ALT) at 36 ml/kg.bw. The LD50 of DCD-684 in mice was 27.5
ml/kg.bw. In hepatocytes at 36 ml/kg.bw, elevated mRNA expression of pro-inflammatory chemokines and cytokines
were evident. DCD-684 neither damaged DNA nor induced cytotoxicity in micronucleus assay. In conclusion,
polyherbal DCD-684 caused neither hepatic, renal, genotoxicity nor any undesirable effect in mice. Higher doses
administered for 90 days showed mild toxic effects with no sign of necrosis, fibrosis or genotoxicity. Thus, in mice
DCD-684 demonstrated a wide margin of safety to be used for the relief of infantile colic.
