The Phase ? Clinical Trial On The Efficacy And Safety Of Liqi Nuanwei Granules Against Chronic Superficial Gastritis (Hepatogastric Disharmony)

Objective To evaluate the effectiveness and safety of Liqi Nuanwei granules in the treatment of chronic superficial gastritis(hepato-gastric disharmony and cold syndrome).Strengthening the post-marketing evaluation work and completing Phase IV clinical work according to regulations[23],focusing on the new security incidents that arise after the diversification of patients and the complexity of administration.Materials and methods More than 2,000 patients with chronic superficial gastritis were collected from multiple centers in City People's Hospital,Yichun,between June 2017 and March 2018.Patients were grouped according to the wishes and needs of the patients.The control group was treated routinely,and the experimental group was treated with granules dissolved in warm boiled-water.One bag at a time and three times a day[24].The course of treatment lasts for4 weeks.If the subject is willing to continue the treatment,the treatment period can be extended to 8 weeks.At the same time,the changes of the individual symptom scores before and after treatment,such as hernia,loss of warming pain,noxiousness,pantothenic acid,and poor appetite,were compared between the two groups,and the follow-up of patients after the trial was actively performed.Results Comparisons of stomach dilatation pain VAS scores,belching VAS scores,stomach ache TCM syndrome scores before and after treatment were performed after two and four weeks.After treatment,the above-mentioned scores showed a significant and consistent decrease.The cure rates of belching TCM syndrome scores[25],TCM syndrome of stomach aches and pains reach a maximum value after 4 weeks of treatment.TCM syndrome scores(gastric fistula,belching,hypothermia,noxiousness,pantothenic acid,and poor appetite)were significantly lower than that before treatment after 2/4 weeks of treatment.After 4 weeks of treatment[26],the obvious curative effect of TCM syndromes has been achieved,and the effective rate reaches the maximum value.The trend of indicators of TCM syndromes is improved and consistent and the conclusions of the data sets are consistent.Conclusions The trial was mainly conducted at the First Affiliated Hospital of Hunan University of Chinese Medicine and a total of 29 medical institutions including the People's Hospital of Yichun City,Jiangxi Province were contained in this research.Totally 2103 cases were enrolled in the study,of which 2004 cases completed the prescription according to the protocol.The following conclusions could be achieved after the analysis of experimental data: more than 2,000 cases that are basically consistent with the market application,can be effectively improved with the chronic superficial gastritis(hepato-gastric disharmony and cold syndrome)Stomach cramps pain,temperature[27],belching,poor appetite,noisy,pantothenic acid and other symptoms after 4 weeks of treatment with Qiqi Nuanwei granule,and a satisfactory tolerance was showed on all the patients.