Comprehensive Evaluation of the Clinical Efficacy of an Anti-Diabetic Polyherbal Formulation

Hasib Sheikh, Md. Khairul Alam, Md. Abdus Samad
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Abstract

Background: There are several clinical studies examining the health advantages of several single medicinal herbs utilized in traditional blood glucose-lowering treatments. But very few or no studies on herbal formulations were made as Polyherbal for the same goal. As a result, it is now necessary to confirm that patients with hyperglycemia can benefit from such Polyherbal medicines as Dolabi. Methods: This prospective open-label, herbal coded test drug-controlled, randomized trial was conducted at the Munshiganj and Dhaka area in Bangladesh. We enrolled 108 male and 104 female patients of 30-70 years with primary and moderate hyperglycemia. They were recruited from the OPD of an Unani & Ayurvedic hospital in Munshiganj and different Unani clinics in Dhaka, Bangladesh after fulfilling the inclusion criteria. Patients were randomly assigned to receive metformin hydrochloride 500 mg two times daily and 2 tablets of Dolabi two times daily by using a random numbers table with the help of an assistant. Blood samples, height, weight, blood pressure, and personal data were recorded—laboratory results were obtained at the study baseline, after 1.5 months and after 3 months of intervention. Results: In the case of the test drug, results showed a significant decrease in blood glucose level between the baseline and after 3 months, in males, it was from 9.83±1.17 to 7.72±1.06 mg/dL for fasting glucose, from 16.60±2.35 to 8.23±1.17 mg/dL for 2 hours PP glucose, from 9.33±1.17 to 7.45±2.03 percent for HbA1c and for Insulin it reduces from 183.10±27.59 to 168.10±29.59 pmol/ L. The control drug metformin hydrochloride also showed a significant decrease in blood glucose level between baseline and after 3 months, in the case of males it was from 9.99±2.52 to 6.97±1.76 mg/dL for fasting glucose, from 17.43±5.05 to 7.89±2.42 mg/dL for 2 hours PP glucose, from 10.43±2.36 to 6.87±1.18 percent for HbA1c and for Insulin it reduces from 198.75±30.61 to 183.75±30.61p mol/L. In the case of females the test drug showed a significant reduction in fasting glucose, 2 hours PP glucose, HbA1c and Insulin between the baseline and after 3 months, it was from 10.02±1.11 to 7.78±0.93 mg/dL, from 16.88±2.21 to 8.16±1.11 mg/dL, from 9.84±1.04 to 7.45±1.03 percent and from 199.47±30.90 to 173.47±30.90 mg/dL respectively. In the case of females, the control drug showed a significant reduction in fasting glucose, 2 hours PP glucose, HbA1c and Insulin between baseline and after 3 months, it was from 10.18±1.92 to 6.71±1.59 mg/dL, from 18.70±3.88 to 7.60±3.74 mg/dL, from 10.58±1.08 to 6.98±1.08 percent and from 200.00±31.83 to 188.00±31.83 mg/dL respectively. Conclusions: We can infer the following from the present study’s findings: The polyherbal formulation Dolabi is able to reduce the blood glucose level. It can be an effective drug for primary hyperglycemic patients.
一种抗糖尿病复方临床疗效的综合评价
背景:有几项临床研究考察了几种单一草药在传统降糖治疗中的健康益处。但很少或根本没有对草药配方的研究是为了同样的目的而做的。因此,现在有必要确认高血糖患者可以从多药如朵拉比中获益。方法:这项前瞻性开放标签、草药编码试验、药物对照、随机试验在孟加拉国的Munshiganj和Dhaka地区进行。我们招募了108名男性和104名女性患者,年龄在30-70岁之间,患有原发性和中度高血糖。他们是从一家乌干达的OPD招募的。Munshiganj的阿育吠陀医院和孟加拉国达卡的不同Unani诊所在满足纳入标准后。在助手的帮助下,使用随机数字表,随机分配患者接受盐酸二甲双胍500 mg,每日2次,多乐比2片,每日2次。记录血液样本、身高、体重、血压和个人数据,并在研究基线、干预1.5个月和干预3个月后获得实验室结果。结果:在试验药物的情况下,结果显示血糖水平在基线和3个月后显著下降,在男性中,空腹血糖从9.83±1.17 mg/dL降至7.72±1.06 mg/dL, 2小时PP血糖从16.60±2.35 mg/dL降至8.23±1.17 mg/dL。HbA1c从9.33±1.17降至7.45±2.03%,胰岛素从183.10±27.59降至168.10±29.59 pmol/ l,对照药物盐酸二甲双胍也显示出基线和3个月后血糖水平的显著下降,男性空腹血糖从9.99±2.52降至6.97±1.76 mg/dL, 2小时PP血糖从17.43±5.05降至7.89±2.42 mg/dL。HbA1c从10.43±2.36降至6.87±1.18%,胰岛素从198.75±30.61降至183.75±30.61p mol/L。在女性中,试验药物显示空腹血糖、2小时PP血糖、HbA1c和胰岛素在基线和3个月后显著降低,分别从10.02±1.11 mg/dL降至7.78±0.93 mg/dL,从16.88±2.21降至8.16±1.11 mg/dL,从9.84±1.04降至7.45±1.03%,从199.47±30.90降至173.47±30.90 mg/dL。在女性病例中,对照药物显示空腹血糖、2小时PP血糖、HbA1c和胰岛素在基线和3个月后显著降低,分别从10.18±1.92 mg/dL降至6.71±1.59 mg/dL,从18.70±3.88降至7.60±3.74 mg/dL,从10.58±1.08降至6.98±1.08%,从200.00±31.83降至188.00±31.83 mg/dL。结论:从本研究结果可以得出以下结论:复方朵拉比具有降低血糖水平的作用。它对原发性高血糖患者是一种有效的药物。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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