Preprint / Version 1

A randomized, controlled, comparative, proof-of-concept study to evaluate the efficacy and safety of Nisha-Amalaki capsules in prediabetic patients for preventing progression to diabetes

Authors

  • Renuka Munshi aDepartment of Clinical Pharmacology, TN Medical College & BYL Nair Charitable Hospital, Mumbai Central, Mumbai 400 008, India
  • Shilpa Karande-Patil bDepartment of Medicine, TN Medical College & BYL Nair Charitable Hospital, Mumbai Central, Mumbai 400 008, India
  • Dipti Kumbhar aDepartment of Clinical Pharmacology, TN Medical College & BYL Nair Charitable Hospital, Mumbai Central, Mumbai 400 008, India
  • Amol Deshmukh cPharmanza Herbals Pvt Ltd, India
  • Lal Hingorani cPharmanza Herbals Pvt Ltd, India

Keywords:

Prameha, Prophylactic, IDRS, HOMA-IR, Ayurvedic symptoms score, Quality of life score

Abstract

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. Objective 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. Methods 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. Results 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. Conclusion 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. Keywords: Prameha, Prophylactic, IDRS, HOMA-IR, Ayurvedic symptoms score, Quality of life score

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