Efficacy of Ma'aljobon Aftimouni (Cuscuta Reflexa and whey) on HbA1c and blood glucose levels in patients with Type 2 Diabetes: A randomized triple-blind clinical trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2025-02-01 DOI:10.1016/j.conctc.2024.101401
Fatemeh Mehrabi , Ali Safdari , Azam Moslemi , Mehdi Salehi , Ali Agharazi , Mohammad Reza Rezvanfar
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Abstract

Introduction and objective

Type 2 Diabetes is a common and chronic metabolic disease. Complementary and alternative medicine can provide a suitable option for demands for new treatments. Therefore, the present study aimed to investigate the effect of Persian medicine on the glycemic status of patients with Type 2 Diabetes.

Method

This randomized, controlled, and triple-blind trial study was conducted from November 2021 to August 2022 on 102 diabetic patients referred to the diabetes clinic in Iran. In this regard, patients with inclusion criteria were randomly divided into three groups Ma'aljobon with Aftimoun (n = 34), Ma'aljobon without Aftimoon (n = 34), and the control group (n = 34). The control group received a placebo of medicinal salt, light calcium carbonate, lactose, and carboxymethyl cellulose. In contrast, the treatment groups received 25 g of drug powder (in 250 cc of lukewarm water) on an empty stomach for 8 consecutive weeks. Patients' fasting blood sugar (FBS) levels and HbA1c were measured at the beginning and end of the intervention. Data were analyzed using SPSS 23, employing paired t-tests, ANOVA, and chi-square tests for comparison between groups.

Results

Data analysis was conducted on 90 patients with Type 2 Diabetes. The findings revealed a significant reduction in fasting blood sugar levels post-intervention in the Ma'aljobon Aftimouni group (134.27 ± 21.79 vs. 152.3 ± 31.37, mean difference 18.03 ± 5.63, 95 % CI: 6.53 to 29.53, p = 0.003). Additionally, a significant difference in HbA1c values was observed post-intervention in both the Ma'aljobon Aftimouni group (7.88 ± 0.77 vs. 8.09 ± 0.73, mean difference 0.21 ± 0.09, 95 % CI: 0.03 to 0.39, p = 0.031) and the Ma'aljobon without Aftimoun group (7.97 ± 0.84 vs. 8.25 ± 0.78, mean difference 0.28 ± 0.08, 95 % CI: 0.11 to 0.45, p = 0.002).

Conclusion

The findings showed that daily consumption of Ma'aljobon supplements on an empty stomach before breakfast may have a beneficial effect on the glycemic indices of patients. However, further studies seem to be necessary in this regard.
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Ma'aljobon Aftimouni (Cuscuta Reflexa和乳清)对2型糖尿病患者HbA1c和血糖水平的疗效:一项随机三盲临床试验
简介与目的:2型糖尿病是一种常见的慢性代谢性疾病。补充和替代医学可以为新疗法的需求提供合适的选择。因此,本研究旨在探讨波斯药对2型糖尿病患者血糖状态的影响。方法:这项随机、对照、三盲试验研究于2021年11月至2022年8月对伊朗糖尿病诊所的102例糖尿病患者进行了研究。为此,将符合纳入标准的患者随机分为Ma'aljobon联合Aftimoun组(n = 34)、Ma'aljobon不联合Aftimoon组(n = 34)和对照组(n = 34)。对照组服用药盐、轻质碳酸钙、乳糖和羧甲基纤维素的安慰剂。治疗组空腹给药25 g药粉(温水250 cc),连续8周。在干预开始和结束时测量患者的空腹血糖(FBS)水平和HbA1c。数据采用SPSS 23进行分析,组间比较采用配对t检验、方差分析和卡方检验。结果:对90例2型糖尿病患者进行数据分析。结果显示,Ma'aljobon Aftimouni组干预后空腹血糖水平显著降低(134.27±21.79 vs 152.3±31.37,平均差异18.03±5.63,95% CI: 6.53 ~ 29.53, p = 0.003)。此外,Ma'aljobon Aftimouni组干预后HbA1c值(7.88±0.77 vs 8.09±0.73,平均差值0.21±0.09,95% CI: 0.03 ~ 0.39, p = 0.031)与Ma'aljobon无Aftimouni组(7.97±0.84 vs 8.25±0.78,平均差值0.28±0.08,95% CI: 0.11 ~ 0.45, p = 0.002)差异有统计学意义。结论:每日早餐前空腹服用Ma'aljobon补充剂对患者的血糖指数有有益的影响。然而,在这方面似乎还需要进一步的研究。
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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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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