The primary objective of the present study was to evaluate the effects of a Nerve Support Formula NeuropAWAY® on diabetic neuropathic pain. Patients aged ≥40 and ≤65 years with a history of type 2 diabetes (T2D) with a confirmed diagnosis of diabetic neuropathic pain were included in the study. The primary efficacy endpoint was to assess the effect of the 42 days administration of the Nerve Support Formula on the neuropathic pain as assessed by the 11 point Pain Intensity Numeric Rating Scale (PI-NRS). The secondary objectives were to assess the effect on plasma vitamin B12 levels, nerve conduction velocity, blood flow velocity, Brief Pain Inventory, Neuropathy Total Symptom Score, and Insomnia Severity Index.

A Hong Kong-based manufacturer of complementary medicine based on TCM approached Vedic Lifesciences for research on an adhesive patch called Patch-It®. They were commercializing this medical device in the UK, US, and Asia for swelling, aching and discomfort in the lower limbs. They needed a formal study to substantiate their claims to their target audience as well as regulatory. A total of 100 patients with recurring swelling in the feet were randomized in this placebo-controlled multi-centric study. Patches were applied to both soles overnight for 8 weeks. Patch-It® was more effective than the placebo in alleviating recurring swelling and aching in the legs and feet.

There were two challenges for this study for a unique product Patch-It^® – firstly such patients were not easily available for clinical research in most parts of the world including India, and secondly, there were not enough centers with a reliable assessment tool for peripheral arterial disease. A minor challenge was to convince investigators, especially their patients to apply the quaint Chinese patch under their feet every night for a fortnight. Patch-It^® is a TCM patch consisting of mandarin wood vinegar, green tea powder and black tourmaline that is to be applied to soles of the feet in peripheral arterial disease. This pilot study was planned to investigate its possible mechanism of action by assessing the transcutaneous oxygen pressure (TcPO₂) and regional perfusion index (RPI).
The results obtained suggest that the product enhances limb blood circulation by improving microcirculation, through a direct or indirect effect on capillary permeability as evident from changes in TcPO₂ and RPI. Thus, completed a most unique study on a highly traditional Chinese medicine using one of the most sophisticated modern equipment that was available in very few centers in India at that time.

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