Multicenter double blind placebo (dummy) controlled randomized trial of treatment with ayurvedic formulation and life style modification in patients with mild to moderate Crohn’s disease.

Crohn’s disease is a chronic inflammatory disorder of the GI tract, affective both small and large intestine, characterized by long-term relapsing and remitting disease course, and requires prolonged treatment for maintenance of remission. Though, the exact pathogenesis of CD is not clear, it probably occurs due to an aberrant immune response causing destruction of intestinal epithelium in genetically pre-disposed individuals under the influence of environmental factors which can negatively affect the gut microbiome. The present treatment for CD targets the aberrant immune response and is limited by higher cost, side effects such as infection and malignancy, and limited efficacy, hence, therapies which can circumvent these barriers are required.

Polyherbal Ayurvedic formulations would be effective, safe and low cost option for treatment of patients with Crohn’s disease. Though these formulations have been in clinical use for hundreds of years, they have not been systematically evaluated in patients with Crohn’s disease. Dadimastak Churna is a traditional polyherbal Ayurvedic formulation, comprising of 14 natural constituents and pomegranate (dadima) is chief ingredient of dadimashtaka churna. It has been mentioned in the Ayurvedic Formulary of India and has been used for centuries in the treatment of diarrhoea, indigestion, dysentery and loss of appetite. Dadimashtak churna has also been advised by the Ayurveda Standard treatment guidelines by Ministry of Ayush for the treatment of Atisara, characterized by chronic diarrhea, a cardinal symptom of Crohn’s disease.

Hence, through a double blind placebo (dummy)controlled RCT plan to determine the efficacy and tolerance of Dadimastak Churna, as an alternative low cost option of treatment of patients with Crohn’s disease. The success of these formulations would also have global relevance and provide a treatment option which would be applicable globally.