Efficacy of Kalonji(Nigella sativa) in Diabetic Neuropathy- a Randomised Placebo Control Study.

Diabetic Neuropathy (DN) is the most common microvascular complication that occursin both type 1 and type 2 diabetes. Diabetic Peripheral Neuropathy (DPN) has been defined as the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetesafter the exclusion of other causes. It is a kind of neurodegenerative disease of the peripheral nerves that primarily affectsautonomic, sensory, and eventually, to a lesser degree, motor axons.

The most common formof diabetic neuropathy is Distal Symmetric Polyneuropathy. It often affects the hands and lowerlimbs and presents as a Stocking and Glove distribution. The important indicators of diabetic neuropathy are an increase in the duration ofdiabetes and HbA1c levels. Presently, it has been shown that the prevalence of DPN in Indiavaries widely, ranging from 9.6 to 78percentage.

According to WHO, the number of people withdiabetic neuropathy has more than tripled globally since 1990, rising to 206 million cases in2021. Damage to the nerves (diabetic neuropathy) affects up to 50% of people with diabetes.Although many different problems can occur as a result of diabetic neuropathy, commonsymptoms are tingling, pain, numbness, or weakness in the feet and hands. Combined withreduced blood flow, neuropathy in the feet increases the chance of foot ulcers and eventuallimb amputation.

Currently, it is treated by supplementation of vitamins (B6, B12, Folate), tricyclicagents (amitriptyline, imipramine), opioid analgesics (tramadol, oxylodone), anticonvulsants(phenytoin, carbamazepine) and gabapentin, but some of these drugs have been reported todevelop side effects.

Ibn Sina (Avicenna) in Al-Qanun fil Tibb has mentioned two specific complications ofdiabetes, which are gangrene and loss of sexual functions. They are closely related to vascularand neurological complications, as described in the modern pathology of diabetic neuropathy.Further, Razi (Rhazes) has mentioned in his book Al Hawi Fit Tib (Liber Continents) theconcept of Khadar (neuropathy) and its occurrence in those tissues, which are somatosensoryin nature.

In Khadar (DN), the following changes occur, 1. Su-i-Mizaj Barid Madda (morbid cold temperament with substance) 2.Tafarruq-i-Ittesal (loss of continuity) – it is correlated with the discontinuity of nerveconduction caused by damage due to axonal degeneration, thickening of Schwann cellbasal lamina, and accumulation of toxic substances in the nerve ending.

As the literature review mentioned the properties of kalonji are Muhallil auram,Musakkin al-waja, and munaffith-i-balgham. The oil of kalonji is Muqawwi-i-bah wa Asab.In the classical book like Ghina Muna, Muhit-i-Azam use of kalonji in khadar(DN) ismentioned. An increasing amount of research links oxidative stress to diabetic neuropathy. Increased free-radical formation and a defect in antioxidant defenses which result in oxidativestress have been implicated in the pathogenesis of diabetic neuropathy.

Kalonji is an annual herb possessing a wide range of medicinal uses apart from itscommercial significance as a spice-yielding plant. Thymoquinone is the most activephytochemical compound in NS. Nigella sativa and thymoquinone have many proventherapeutic activities, and some potent activities are Antioxidants, immunomodulative, antiinflammatory, anti-diabetic, and Neuroprotective. Animal studies have beenconducted on the effect of kalonji on Sciatic nerves in experimental Diabetic Neuropathy.With the help of literature research, in this study, an attempt is made to evaluate theefficacy of Kalonji in Diabetic Peripheral Neuropathy.