Munshi Renuka, Karande-Patil Shilpa, Kumbhar Dipti, Deshmukh Amol, Hingorani Lal
Department of Clinical Pharmacology, TN Medical College & BYL Nair Charitable Hospital, Mumbai Central, Mumbai 400 008, India.
Department of Medicine, TN Medical College & BYL Nair Charitable Hospital, Mumbai Central, Mumbai 400 008, India.
J Ayurveda Integr Med. 2023 Nov-Dec;14(6):100806. doi: 10.1016/j.jaim.2023.100806. Epub 2023 Oct 17.
Prediabetes is an intermediate state of hyperglycemia, which acts as a precursor to Diabetes mellitus if left untreated. Nisha (Curcuma longa) and Amalaki (Emblica officinalis) combination has been advocated as drugs of choice to treat the early manifestations of Diabetes mellitus.
This prospective, randomized, single-blind, placebo-controlled, comparative study was planned to assess the efficacy and safety of Nisha-Amalaki capsules in preventing progression to Diabetes mellitus in prediabetic patients when administered for 6 months.
The study was conducted on prediabetic participants randomized to receive either Nisha-Amalaki (500 mg) or placebo one capsule twice a day for six months. The effect of study medications on IDRS (Indian Diabetes Risk Score), BMI (Body Mass Index), blood sugar, serum insulin, HOMA-IR (Homeostasis Model Assessment-Estimated Insulin Resistance), HbA1c (glycated hemoglobin), oxidative markers, Ayurvedic symptoms and Quality of Life (QoL) scores was assessed at regular intervals.
58 of the 62 participants enrolled completed the study. Significant fall in IDRS score [p < 0.001], BMI [p < 0.001], fasting, and 2 h post-OGTT sugar, insulin, HbA1c, HOMA-IR, and oxidative stress markers [p < 0.001] was observed in patients receiving Nisha-Amalaki at 6 months. Ayurvedic symptoms and QoL scores also improved at 6 months in the treatment group.
Treatment with Nisha-Amalaki capsules improved all study parameters including insulin sensitivity at 6 months as compared to placebo in prediabetic patients. Thus Nisha-Amalaki should be considered as prophylactic therapy in prediabetics to delay progression to diabetes.
糖尿病前期是高血糖的一种中间状态，如果不治疗，它会成为糖尿病的先兆。姜黄（郁金）和余甘子（余甘子）的组合已被推荐为治疗糖尿病早期表现的首选药物。
本前瞻性、随机、单盲、安慰剂对照的比较研究旨在评估姜黄 - 余甘子胶囊在对糖尿病前期患者给药6个月时预防进展为糖尿病的疗效和安全性。
该研究针对随机分为接受姜黄 - 余甘子（500毫克）或安慰剂的糖尿病前期参与者进行，每天两次，每次一粒胶囊，持续六个月。定期评估研究药物对印度糖尿病风险评分（IDRS）、体重指数（BMI）、血糖、血清胰岛素、稳态模型评估 - 估计胰岛素抵抗（HOMA - IR）、糖化血红蛋白（HbA1c）、氧化标志物、阿育吠陀症状和生活质量（QoL）评分的影响。
62名入组参与者中有58名完成了研究。在接受姜黄 - 余甘子治疗6个月的患者中，观察到IDRS评分[p < 0.001]、BMI[p < 0.001]、空腹及口服葡萄糖耐量试验后2小时血糖、胰岛素、HbA1c、HOMA - IR和氧化应激标志物[p < 0.001]显著下降。治疗组的阿育吠陀症状和QoL评分在6个月时也有所改善。
与安慰剂相比，姜黄 - 余甘子胶囊治疗在6个月时改善了所有研究参数，包括糖尿病前期患者的胰岛素敏感性。因此，姜黄 - 余甘子应被视为糖尿病前期患者的预防性治疗，以延缓进展为糖尿病。
