HPTLC characterization of Tinospora cordifolia (Guduchi/Giloy) mother tincture and a randomized clinical comparison with individualized homeopathic medicines in adults with type 2 diabetes mellitus

Tinospora cordifolia in diabetes mellitus

Abstract

Diabetes mellitus (DM) is a chronic metabolic disorder and remains a major contributor to the global burden of disease. The present study focused on the standardization of Tinospora cordifolia (TC) mother tincture (Ø), a medicinal plant widely used in Ayurveda for its antidiabetic potential and known to contain alkaloids such as berberine and palmatine. Standardization was carried out using high-performance thin layer chromatography (HPTLC), along with other established quality-control procedures, and the clinical effects of TCØ were compared with those of individualized homeopathic medicines (IHMs) in adults with type II DM. Pharmacognostic (microscopic), physicochemical (including ash and extractive values), and pharmacological evaluations were performed, supported by thin layer chromatography (TLC), UV spectrophotometry, and HPTLC, to assess the purity, consistency, and overall quality of the preparation. The clinical component was an open-label, randomized (1:1), two-arm pragmatic trial conducted over 3 months in 60 participants with type II DM. Patients received either TCØ (n = 30) or IHMs (n = 30), in addition to standardized dietary advice and lifestyle modification. Primary outcome measures included fasting blood sugar (FBS), post-prandial blood sugar (PPBS), and HbA1c%, while secondary outcomes comprised lipid profile, urea, and creatinine. All outcomes were assessed at baseline and at the end of 3 months, and between-group differences were analysed using unpaired t-tests with Bonferroni-adjusted significance (p<0.0167). TCØ demonstrated superior efficacy: HbA1c% (mean difference -1.3±0.5, 95% CI -2.3 to -0.4, p=0.006), FBS (-38.4±13.7, 95% CI -66.0 to -10.9, p=0.007), PPBS (-70.8±22.9, 95% CI -116.7 to -24.9, p=0.003), favouring TC over IHMs. Secondary outcomes showed trends that did not reach statistical significance (p>0.0167), and non-inferiority could not be demonstrated (p>0.773). Among the individualized homeopathic medicines prescribed, Carcinosinum, Causticum, and Crataegus oxyacantha were most frequently used. No adverse events were reported in either study arm. Overall, these findings are consistent with earlier trials of Tinospora cordifolia that have reported improvements in glycemic parameters when used as an add-on intervention, and they support the need for larger, well-designed blinded studies.