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Amazon.com: Bladder Regulator, Gosha Jinki Gan an Effective Herbal Bladder Control Support Formula: Health & Personal CareComplementary and evidence-based alternative medicineOn this page Collaboration of Medicine Kampo Japonesa and Biomedicine ModernaInvestigation Article ANTE Open AccessK. Watanabe, A. Shimada, K. Miyaki, A. Hirakata, K. Matsuoka, K. Omae, I. Takei, "Long-term effects of Goshajinkigan on the prevention of diabetic complications: a clinical trial of randomized open label87." https://doi.org/10.1155/2014/128726Long-Term University of Shinkajinkigan for prevention Watanabe1 Kampo Medical Center, Faculty of Environment and Information Study, Keio University School of Medicine, 5322 Endo, Fujisawa, Kanagawa 252-0882, Japan2 Internal Medicine Division, Saiseikai Central Hospital, 1-14-17 Mita This clinical trial was designed to investigate whether goshajinkigan reduces the start of diabetic complications or not. Materials and Methods. A total of 332 diabetic patients of type 2 mellitus were registered from 9 clinical centers from March 2000 to August 2007. Patients were randomly assigned to take goshajinkigan extract powder, 2.5 grams per 3 times a day or without kampotherapy, in addition to regular treatment. The main final points were the initiation of macrovascular diseases or the progression of nephropathy or retinopathy. Statistical analysis was performed by the method of intent to treat. Results. After 5 years of observation, 116 patients were subjected to analysis. Among them, no macrovascular events were observed in both groups. Although 43 participants had a level of retinopathy or total nephropathy, there was no significant difference between the goshajinkigan group and the control group. The deterioration of the reflex of the ankle was suppressed in the goshajinkigan group. Also glucose glucose hemoglobin glucose glucose glucose glucose glucose in the goshajinkigan group. Conclusion. Although the power of the analysis was too low to demonstrate any goshajinkigan effect on the progression of macrovascular diseases, retinopathy or nephropathy, goshajinkigan may be beneficial to diabetic neuropathy and glucemic control.1. IntroductionDiabetes mellitus has become a big problem worldwide. Also in Japan, the number of patients with diabetes mellitus has increased steadily every year. In 1998, the Ministry of Health and Welfare estimated that there were 6.9 million diabetics in Japan. Subsequently, this estimate increased to 7.4 million and 8.9 million in 2002 and 2007, respectively []. According to the Atlas of Diabetes (International Diabetes Federation) published in 2011, the number of patients with diabetes living in Japan was 10.7 million []. Several studies have shown that the progression of diabetic microvascular complications, such as retinopathy, nephropathy and neuropathy, can be inhibited by good glycemic control [–]. However, several randomized, large-scale clinical trials have shown that glucemic control alone was not sufficient to prevent the progression of macrovascular complications, such as brain and myocardial infarction [–]. In addition, in terms of arteriosclerosis and microcirculation disorders, older people usually have several risk factors for cardiovascular events, including hypertension and dyslipidemia []. However, the protective effects of antihypertensive therapy and lipid control have been found with limited effects to prevent macrovascular complications. Therefore, it is necessary to improve the lifestyle, such as quitting and controlling the weight. Given the above, avoiding the progression of complications only by glucemic control in the elderly is difficult, and new treatment methods are needed []. The clinical conditions similar to diabetes were treated with hachimijiogan administration at the Jingui Yaolue, a Chinese classic written about 1,800 years ago. Goshajinkigan, a kampo product, contains 10 herbal ingredients that add two herbs, that is, Achyranthis radix and Plantaginis semen, a hachimijiogan and applies to patients with lumbago, edema of the lower legs, dissuria, etc. In an animal model of diabetes, goshajinkigan showed weight gain inhibition, blood glucose inhibitors, microalbuminuria suppression [], preventive effects on hypertriglyremia [], platelet aggregation inhibition [], and pain threshold elevation [,], all of which seemed to be effective in preventing new complications of diabetes. However, to date no report has been published on the preventive effects of goshajinkigan for diabetic complications, with the exception of neuropathy and corneal disorders []. As such, a comprehensive study is needed to investigate whether kampo is effective in preventing the progression of diabetic complications. This trial was specifically designed to determine whether a goshajinkigan kampo formulation would reduce the rate of cardiovascular events, microvascular complications and laboratory abnormalities, compared to a control group without this kampo formulation in middle-aged and older people with type 2 diabetes mellitus and additional cardiovascular risk factors. Here, we report the effects of kampo formulation on the primary compound result of major cardiovascular events and microvascular complications in middle-aged and older people with type 2 diabetes mellitus. Methods This multicenter clinical trial was conducted in 9 clinical centers in Japan. We contract external patients with type 2 diabetes mellitus between 40 and 75 years of March 2000 to August 2007. To investigate the progression of diabetic complications, the level of hemoglobin ≥6.5% was selected in the inclusion criteria. Exclusion criteria were past macrovascular events, such as cerebelal stroke, myocardial infarction, angina pectoris, foot gangrene or atherosclerotic obstruction. Other exclusion criteria were macroalbuminuria nephropathy or serum creatinine levels of 1 mg/dL or more and proliferative and preproliferative retinopathy. Additional exclusion criteria related to the pattern of goshajinkigan were a body mass index of ≥30 kg/m2, 2 or more symptoms of the digestive system (e.g. gastrointestinal weakness, anorexia, nausea and diarrhea), and 3 or more indicative symptoms or activities of heat sensitivity, including a preference for slightly dressing, sweating up from the neck, a trend to drink All 116 patients were assigned to the goshajinkigan group or control group. Randomization was performed by a study controller, and assignments were provided in sealed envelopes. Due to the long-term clinical trial, we anticipate that the dropout rate is high in the goshajinkigan group and the assignment to the goshajinkigan group was planned to be twice the control group. The trial was opened once the patients were randomized. Only the readers of the background photographs were blinded. No placebo treatments were given. As a background treatment, all participants received nutrition and physical activity advising each year when entering the study. Nutritional guidance included a recommendation that caloric intake should not exceed the number of calories derived from multiplying the estimated body weight (kg) by a factor of 25. Current smokers and drinkers received advice on smoking and quit drinking. All participants received low-glucose therapy, the same as the one before the study, as well as low-use lipid therapy and/or blood pressure reduction therapy. No restrictions were imposed on the choice of medicines, except that no kampo formula other than goshajinkigan could be used. Focused hemoglobin was less than 6.9% (National Glycohemoglobin Normalization Program); targeted blood pressure was lower than 130/85; target body mass index was less than 22.0 kg/m2; total target cholesterol was less than 220 mg/dL; high-density lipoprotein was higher than 40 mg/dL, according to the Jabetes Society Guide Patients received teaching materials and behavioral advice on diabetes care and received goshajinkigan. Therapeutic regimes were identified at the discretion of researchers and patients on the basis of assignments of study groups and response to therapy. The adverse effects of therapy were carefully audited at both local and central levels to ensure patient safety. The patients in the goshajinkigan treatment group received 2.5 g of goshajinkigan extract (TJ-107; Tsumura Co., Tokyo, Japan) preprandially that includes 4.5 g of extracts composed of 10 herbal drugs: Rehmanniae radix (5g), Achyranthis radixsum (3g), Corni fructus cut (3g), Dioscoreae rhizoma (3giti) The manufacturing process meets all requirements of the Japanese and international GMP guidelines. The pre-spected primary endpoints were the first appearance of nonfatal myocardial infarction or nonfatal spill or worsening diabetic nephropathy (DNA) or retinopathy (DR). The progression of the DN was evaluated by the new beginning of kidney failure due to dialysis or an increase in the amount of urinary protein. The urinary protein was calculated by dividing the urinary albumin by urinary creatinine not related to any acute intercurrent disease. The amount of urinary protein was divided into 3 stages: 300 mg/g The progression of the RD was evaluated by standard eye exams performed by ophthalmologists or optometrists, along with the background photography of 4 standard stereoscopic fields at the base and each year. The photographs were gathered at the Fundus Photo Reading Center, located at the University of Kyorin (Mitaka, Tokyo), and were qualified by trained personnel masked to the treatment allocations of the participants. The presence of capillary aneurysms, retinal bleeding, hard exudate, hard exudate resembling the ring, soft exudate, intraretineal microvascular abnormalities, venous anomalies and new blood vessels was evaluated. The DR stage was divided into 8 steps from normal to proliferating (3 classifications each corresponding to simple and pre-proliferative steps). The study researchers also measured the effect of the intervention on body weight, blood pressure, blood glucose, hemoglobin glucose, serum insulin (C-peptide-user reactivity of insulin), total cholesterol, triglyceride, high-density lipoprotein, serum creatinine, urea nitrogen and DN as side results. The ND was evaluated through bidirectional analysis of variance. The degree of the reflex of the ankle was classified in 3 steps: normal, decreased and absent. In addition, the results of the questionnaire on 10 subjective symptoms were evaluated by 4 steps, and 4 of these 10 symptoms were also evaluated with a visual analogue scale (grade 0 to 100). The questionnaire included head of light, abnormal sweating, appearance of constipation and diarrhea, impotence, abnormal feeling like pater glued to plants, uncomfortable feeling of heat of hands and feet, pain of hands and feet, abnormal feeling of hands and feet, cold feeling of hands and feet, and muscle cramp. To monitor side effects, aminotransferase aspartada, aminotransferase alanine, serum creatinine, urea nitrogen, uric acid, urinary blood, glucose and ketona were investigated every 6 months. When critical side effects were suspected due to goshajinkigan, treatment was stopped immediately and appropriate treatment was performed. Concomitantly, a report was quickly made to the research centre. We had the objective of recruiting 1000 cases for the goshajinkigan group and 500 for the control group. The sample size was calculated for an event rate of 6% per year, an effect of 20%, an alpha error of 5%, and a power level of 80%. All statistical analyses were performed at the focal point with the use of SAS software, version 9.1 (SAS Institute). The basal characteristics were compared in the 2 study groups with the use of chi-square tests and two sample tests. In each evaluation visit, the levels of hemoglobin glucose glucose glucose glucose glucose glucose glucose were summed up with the use of medians and interquartile ranges. According to the study group, exposure to low-glucose-consumption drugs was summarized as the number of patients who received a prescription for a drug. The analysis of the primary result was performed with the use of the log-rank method according to the principle of intention-treatment, and the cases of this result in the 2 study groups were compared with the use of risk ratios and confidence intervals of 95%. Kaplan-Meier estimates were used to obtain the proportion of patients who had an event during follow-up. The analysis of the side results was performed with the use of log-rank methods, two Wilcoxon samples test and Fisher's exact test. Here we report all nominal values, unjustified by the multiplicity associated with the various tests performed for this study or the monitoring of the primary endpoints and mortality by the data monitoring and security committee.3. Results 332 patients were registered for this clinical trial (Figure), of which 162 patients were excluded because they had no criteria. The main reason for exclusion was retinopathy. Although, in regular ophthalmological control, these patients coincided with the inclusion criteria, background photography revealed that these patients did not match the inclusion criteria. Another reason was the pattern of goshajinkigan. This was relatively difficult for the doctor who contributed to this study. As a result, 170 patients were assigned to the goshajinkigan group (GJG) () to the control group (). A total of 116 patients were presented for the analysis of this study. The table shows the reference characteristics of two groups. The age, sexual distribution and duration of diabetes were similar in the 2 study groups. Smoking habits were also similar. The blood chemistry profile was also similar in the 2 groups. The average follow-up duration was 28 months for the goshajinkigan group and 15 months for the control group. 0,21,0,0,0 There were no macrovascular events, such as myocardial infarction, angina pectoris or strokes, in any group. None of the patients had macrovascular events. A total of 43 participants had a progression of stages in nephropathy or retinopathy: 40.2% in the goshajinkigan group and 39.1% in the control group (Figure ). In terms of nephropathy, 25 participants had nephropathy at the end of this study: 27.2% in goshajinkigan group and 18.7% in control group () (Figure ). In terms of retinopathy, a total of 25 participants had nephropathy at the end of this study: 17.9% in goshajinkigan group and 20.0% in control group () (Figure). The progression of the degree of the ankle reflex was significantly more frequent in the control group. The risk ratio was calculated as 0.436 (95% CI: 0.198–0.962), and the value was 0.040 as determined by the registration test (Figure ). They were maintained in the goshajinkigan and control groups, respectively, stable median levels of glucose hemoglobin of 7.8% (interquartile range, 6,4–11,5) and 7.9% (interquartile range, 6,7–13,5). According to an exploratory examination, the glucated hemoglobin of the goshajinkigan group decreased significantly in the 60th month compared to the control group (Figure ). Plasmatic fasting glucose also decreased significantly from the 36th month on the base (Figure) while no significant changes were observed in the control group. No significant differences were observed in terms of insulin doses or oral antidiabetic drugs. Most patients did not have subjective symptoms during the trial period. An analysis was performed of only patients who had a change in subjective symptoms, in addition to an analysis of the entire patient group. For patients who experienced a change in symptoms, the appearance of constipation and diarrhea was significantly improved in the goshajinkigan group. For the entire group of patients, there were no significant changes in any of the issues addressed in the questionnaire. There was no desertion due to the side effects of goshajinkigan. Other results, including body mass index and laboratory test results, showed no significant differences.4. DiscussionThe goshajinkigan extract (TJ-107) is a drug covered by the national health insurance program. The indications include pain in low limbs, back pain, numbness, blurred vision, disssury, cockkiuria and edema. It is mainly used for senile problems. Goshajinkigan is a medication for kidney function deficiency in terms of traditional medicine. Kidney function deficiency means a loss of congenital energy. With aging, this function deteriorates. In this case, renal function is not the function of the organ kidney. The kidney maintains congenital energy and, with aging, this function deteriorates. Goshajinkigan is hachimijiogan derivative and add two additional herbs, Achyranthis Radix and Plantaginis Semen. There are studies to show hachimijiogan or goshajinkigan is effective for diabetic complications. Yokozawa et al. investigated that hachimijiogan had a protective effect against diabetic nephropathy in animal models [–]. They speculated that the hachimijiogan mechanism is the protection of the formation of advanced final glucocation product by Corni Fructus which is one of the ingredients of hachimijiogan [] or the suppression of oxidative stress []. For retinopathy, Cameron-Schaefer et al. showed the protective effect of goshajinkigan against diabetic retinopathy []. They showed that lipid peroxide was enhanced by tyreptozotocin-induced hyperglycemia and that goshajinkigan prevented lipid peroxide. They showed that the soluble activation of guanylate cyclase is a key mechanism to decrease lipid peroxide. Although it has not been shown that goshajinkigan prevented diabetic macroangiopathy, Suzuki et al. assessed the effects of goshajinkigan in the aggregation of platelets in diabetic rats induced by streptozotocin. They concluded that goshajinkigan could improve the aggregation of platelets in diabetes through increased production of nitric oxide through bradykinin B2 receptors and muscarinic acetylcholine receptors []. This clinical trial was designed on the basis of these publications. However, we find a difference between animal models and complex clinical trials. The chosen final point, macroangiopathy, could have been inappropriate for the clinical environment in such a short period. While changes in microangiopathy may not be anatomically visible in background photography, goshajinkigan could influence the metabolism of retina and thus have effects on a functional level, an effect that cannot be easily studied in live humans. There had been no cases of macrovascular events. And there were no differences in the progression of retinopathy and nephropathy. Because the progression of retinopathy and nephropathy takes time, we enroll patients with type 2 diabetes with moderate hyperglycemia. However, 5 years of follow-up time is long for patients and the final number for the analysis was only 116 cases. Power was very low compared to the original calculation. So we could not conclude any definite effect of goshajinkigan in the prevention of macrovascular events such as myocardial brain infarction or stroke, nor could we indicate effects on diabetic nephropathy. Recently some macroangiopathy markers were proposed, such as mediated flow dilation, the brachial pressure rate of the ankle or the pulse wave rate. These are covered by Japanese national health insurance and could be taken into account as substitute markers. On the other hand, our results support a beneficial effect of goshajinkigan in diabetic neuropathy, which we choose as a secondary endpoint. There have been many manuscripts showing that goshajinkigan had a beneficial effect on diabetic neuropathy in the animal model [] or in the clinical settings [, ].The goshajinkigan action mechanism in diabetic neuropathy was partially speculated by the inhibition of the aldose reductase [, ].In addition, recently, goifjinkigan was reported to relieve the advanced neuropathy This can be explained by the variable modes of action of the different ingredient of goshajinkigan. Our data have also shown that goshajinkigan has some beneficial effect on serum glucose and glucose hemoglobin. When we have compared medication in two groups, patients in the control group had more advanced medications in 5 years (not medications or insulin medications). The body mass index was similar to the beginning of this study, but in 5 years, the GJG group maintained the BMI and the control group lost weight. These two facts argue that GJG reduces serum glucose compared to the control group. Because the difference in serum blood glucose or glucose hemoglobin was observed only in recent years, we assume that GJG itself does not affect insulin secretion itself. An improvement in insulin resistance may be involved in reducing the level of glucose in blood. This speculation was supported by previous studies [, ].In large RCTs such as the Action to Control Cardiovascular Risk in Diabetes and Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation trial [, ], hypoglycemia has been observed as one of the reasons why strict glucemic control showed no benefit to reduce the incidence and mortality of macroangiopathy. If goshajinkigan can control blood glucose without any risk of hypoglycemia, patients can receive it with long-term safety. Although primary endpoints were not met, our data support a positive effect of goshajinkigan on diabetic neuropathy. In addition, it could positively affect long-term glucose metabolism. More studies are needed with the focus of diabetic microangiopathy and especially neuropathy. Conflict of interest Center for Kampo Medicine, Keio University, was financially supported by Tsumura & Company. Dr. Watanabe received fees from Tsumura & Company for talking about commitments. The other authors do not report any conflict of interest or need for disclosure. Acknowledgements Kyoka Hospital, Tokyo University, Koma University Medical Center, Tokyo University Medical Center, Tokyo University Medical Center, Tokyo University Medical Center, K. Oaku University Medical Center, Tokyo University, This study was supported by grants from the Research Council of the Ministry of Health, Labour and Welfare of Japan (the main financial sponsor), and Tsumura Co., the goshajinkigan manufacturer. For the preparation of the paper, we appreciate Dr. Tetsuhiro Yoshino of the Faculty of Medicine of the University of Keio. ReferencesCopyrightCopyright © 2014 K. Watanabe et al. This is an open access article distributed under the article, which allows unrestricted use, distribution and reproduction in any medium, provided that the original work is duly cited. More related articles Share Related articles

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