Clinical Effect of Poly Herbal Unani Formulation on Dyslipidemia- A Randomized Trial

Khairul Alam, Hasib Sheikh, Md. Abdus Samad
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Abstract

Background: In adults aged 30-70 with primary and moderate hyperlipidemia, the present study took place to investigate the therapeutic benefits of a polyherbal unani preparation called Garlitab. Methods: It was a prospective open label, herbal coded test drug-controlled, randomized trial. Out of total screened patients we were enrolled 212 hyperlipidemic patients of 30–70 years in the study fulfilling the inclusion criteria, we were recruited them from OPD of a hospital in Munshiganj and different Unani clinics of Dhaka, Bangladesh after obtaining written informed consent from the patients. Selected individuals were allocated into two groups at random. Group1 Received 500 mg Garlitab tablets twice daily and Group 2 received tablet atorvastatin calcium 10 mg 2 times daily. Height, weight, and blood pressure were recorded along with blood samples. The random distributions were carried out by a research assistant utilizing a random numbers table. Blood samples were taken at the beginning of the trial, 1.5 months later, and 3 months following the intervention. Results: Results for the test medication revealed a substantial drop in cholesterol levels between baseline and the data collected after three months and in case of male it was from 241.72±38.11 to 218.24±34.06 mg/dL for total cholesterol, from 198.27±30.57 to 173.54±29.34 mg/dL for LDL and from 280.78±85.81 to 207.07±51.40 mg/dL for triglyceride. HDL increases from 33.05±3.21 to 34.69±3.13 mg/dL in male patients. The control drug atorvastatin calcium also showed a significant decrease in lipids between baseline and after 3 months data and in case of male it was from 241.92±31.54 to 174.90±22.87 mg/dL for total cholesterol, from 196.20±30.91 to 130.30±24.29 mg/dL for LDL and from 279.48±115.35 to 141.27±59.55 mg/dL for triglyceride. It increases HDL from 32.00±2.25 to 34.03±2.19 mg/dL in male patients. Between the baseline and the 3-month data, the test medicine for females significantly reduced total cholesterol, LDL, and triglycerides and it was from 244.64±52.18 to 220.12±45.07 mg/dL, from 200.32±30.57 to 173.54±29.34 mg/dL and from 272.32±99.69 to 195.25±60.68 mg/dL respectively. HDL increases from 33.77±3.36 to 35.03±3.23 mg/dL. Between the baseline and the 3-month data, the control medication for females significantly reduced total cholesterol, LDL, and triglycerides and it was from 247.74±37.95 to 175.26±29.54 mg/dL, from 197.65±27.89 to 130.91±22.04 mg/dL and from 271.57±94.52 to 142.00±50.88 mg/dL respectively. It increases HDL from 32.22±2.32 to 33.46±2.94 mg/dL. Conclusions: According to the results of the study, the polyherbal formulation Garlitab can lower cholesterol levels. It may be a useful medication for treating primary hyperlipidemia.
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复方乌尼方治疗血脂异常的临床疗效——随机试验
背景:在30-70岁患有原发性和中度高脂血症的成年人中,本研究调查了一种名为Garlitab的多草药unani制剂的治疗效果。方法:前瞻性开放标签、草药编码试验、药物对照、随机试验。在所有筛选的患者中,我们招募了212名符合纳入标准的30-70岁的高脂血症患者,我们在获得患者的书面知情同意后,从Munshiganj一家医院的门诊和孟加拉国达卡的不同Unani诊所招募了他们。选定的个体被随机分为两组。组1患者给予加立他片500 mg,每日2次;组2患者给予阿托伐他汀钙片10 mg,每日2次。身高、体重、血压和血液样本一起被记录下来。随机分布由一名研究助理利用随机数表进行。在试验开始时、1.5个月后和干预后3个月采集血样。结果:测试药物的结果显示,在基线和三个月后收集的数据之间,胆固醇水平大幅下降,在男性中,总胆固醇从241.72±38.11降至218.24±34.06 mg/dL, LDL从198.27±30.57降至173.54±29.34 mg/dL,甘油三酯从280.78±85.81降至207.07±51.40 mg/dL。男性患者HDL从33.05±3.21 mg/dL增加到34.69±3.13 mg/dL。对照药物阿托伐他汀钙也显示,在基线和3个月后的数据中,男性的总胆固醇从241.92±31.54降至174.90±22.87 mg/dL, LDL从196.20±30.91降至130.30±24.29 mg/dL,甘油三酯从279.48±115.35降至141.27±59.55 mg/dL。使男性患者HDL从32.00±2.25 mg/dL增加到34.03±2.19 mg/dL。在基线和3个月的数据之间,女性试验药物显著降低总胆固醇、低密度脂蛋白和甘油三酯,分别从244.64±52.18 mg/dL降至220.12±45.07 mg/dL,从200.32±30.57降至173.54±29.34 mg/dL和从272.32±99.69降至195.25±60.68 mg/dL。HDL从33.77±3.36 mg/dL增加到35.03±3.23 mg/dL。在基线和3个月的数据之间,女性对照药物显著降低了总胆固醇、低密度脂蛋白和甘油三酯,分别从247.74±37.95 mg/dL降至175.26±29.54 mg/dL,从197.65±27.89降至130.91±22.04 mg/dL和从271.57±94.52降至142.00±50.88 mg/dL。使HDL从32.22±2.32 mg/dL增加到33.46±2.94 mg/dL。结论:复方Garlitab具有降低胆固醇水平的作用。它可能是治疗原发性高脂血症的有效药物。
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