ABSTRACT
Objectives: Prediabetes is a major public health concern. Different plant extracts are used in homeopathy as mother tinctures (MTs) for the treatment of prediabetes as an adjunct to individualized homeopathic medicines (IHMs); however, their effectiveness remains under-researched. Design: Open-label, randomized (1:1), active-controlled, pragmatic, exploratory trial. Setting: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Subjects: Eighty-nine patients with prediabetes. Interventions: Group 1 (n = 45; IHMs plus any one of the following MTs: Cephalandra indica, Gymnema sylvestre, and Syzygium jambolanum; experimental/verum) versus Group 2 (n = 44; IHMs only; control). Outcome measures: Blood parameters, including-the fasting blood sugar (FBS) level, blood sugar level 2 h after ingestion of 75 g of glucose (oral glucose tolerance test [OGTT] result), and glycosylated hemoglobin percentage (HbA1c%), and symptoms, including the Diabetes Symptom Checklist-Revised (DSC-R) score; all of them were measured at baseline and after 3 and 6 months. Results: Although recruitment of 140 patients was initially planned, the target sample size could not be achieved because of coronavirus disease pandemic-related restrictions. Only 89 patients could be enrolled, and the trial had to be terminated prematurely owing to the time constraints of the project. The data of 82 patients (Group 1, n = 40; Group 2, n = 42) were analyzed using a modified intention-to-treat approach. Improvements in all outcomes were greater in Group 1 than in Group 2, but without a significant difference: FBS level (F1, 80 = 4.095, p = 0.046), OGTT result (F1, 80 = 2.399, p = 0.125), HbA1c% (F1, 80 = 1.612, p = 0.208), and DSC-R score (F1, 80 = 0.023, p = 0.880). Conclusions: A promising but nonsignificant trend favored the combination of MTs and IHMs compared with IHMs alone among the patients with prediabetes, especially in FBS. Therefore, further studies are required. Clinical Trial Registration Number: CTRI/2018/08/015319; secondary identifier (UTN): U1111-1218-6016.