A research group led by Professor Takanori Kanai of Keio University has scientifically demonstrated in a placebo-controlled clinical trial that plant-derived dyes are effective in treating active ulcerative colitis.
Seitai is a crude drug of powder extracted from plants such as pink strobilanthes and persicaria tinctorum. Its effectiveness and safety have not been verified.In recent years, even in Japan, there have been cases of self-purchase and folk remedies based on uncertain information such as Internet information, rumors, and word-of-mouth, which has been regarded as a problem.
The research group focused on the fact that the components (indigo, indirubin) contained in Aomori are "indole compounds", which are said to promote mucosal healing.So far, a small number of single-center studies have suggested that it may be highly effective for patients with ulcerative colitis.
In this study, we conducted a multicenter clinical trial at 33 centers nationwide, including a comparison with placebo (placebo), in patients with moderate or higher active phase ulcerative colitis for verification including the setting of safe doses.
As a result, Aomori showed a high efficacy of 70-81%, and also had a high clinical remission rate indicating symptom disappearance and a mucosal healing rate (endoscopic remission rate).However, more than 5% of patients had mild adverse events such as transient liver injury and headache.
Not related to this study, the Ministry of Health, Labor and Welfare warns that doctors will instruct patients not to take Aomori at their own discretion in response to cases of pulmonary arterial hypertension in patients who took Aomori as a folk remedy. The arousal was sent to related academic societies (December 28).After that, the results were announced after suspending this clinical trial in consideration of safety.
From this result, it is expected to elucidate the pathological condition and develop a new therapeutic drug aiming at the complete cure of ulcerative colitis in the future.At this stage, we do not recommend the use of Aomori at the patient's own discretion due to safety concerns.In the future, the company plans to proceed with safety verification through research including animal experiments.
Paper information:[Gastroenterology] Efficacy of Indigo naturalis in a Multicenter Randomized Controlled Trial of Patients with Ulcerative Colitis
