An open-label randomized controlled trial to evaluate the efficacy of Vidangadi Ghanavati and Gokshuradi Guggulu after Virechana Karma versus Gabapentin in managing Pittavritta Madhumeha (Diabetic Neuropathy) in patients on conventional therapy

As we all know India is home to the world’s second highest number of diabetic patients. Within the age group of 20–79 years, India had 74.9 million diabetics in 2021 projected to increase to 124.9 million by 2045.[i] At the time a patient is diagnosed with diabetes, the literature estimates that 10% to 20% of these patients are concomitantly diagnosed with Diabetic Neuropathy; however, studies analyzing patients with long-standing diabetes mellitus report that Diabetic Neuropathy has a higher prevalence in those patients. After 5 years, 26% have peripheral neuropathy, and 41% of patients with diabetes have neuropathy at 10 years. The literature reports that 50% to 66% of patients with diabetes mellitus will eventually develop Diabetic Neuropathy during their lifetime.[ii] Diabetic neuropathy is the most common complication among diabetic patients with a prevalence ranging from 18.8 to 61.9% in India.[iii]

All these data show that there is a huge burden of diabetic neuropathy in society due to a lack of information regarding this disease. Diabetic Neuropathy considerably reduces the quality of life, causes disability due to foot ulceration and gait disturbances, and significantly increases the cost associated with diabetic care.In modern medicine, it is treated with gabapentin, pregabalin, and centrally-acting opioid analgesics (like tapentadol). Despite these modern medications, patients get relief only for a short period and thus become dependent on analgesics.

Ayurveda advocates various herbal, herb mineral drugs, Panchakarma procedures, and lifestyle modification in the comprehensive care of Diabetes and its complications. According to Ayurveda concepts, Diabetic Neuropathy is a Vatika-Paitik disorder in which vitiated Vayu causes Parishoshan of Snayughat Kapha (Sneha) and Parishoshan of Tarpaka Kapha which further leads to decreased quantity of  Snayughat Kapha. Tarpaka Kapha provides nutrition to Indriyas. Due to a decrease in the quantity of Tarpaka Kapha, the nutrition of Indriyas (sensory and motor) is decreased which leads to a decrease in the function of Indriyas. Thus, vitiated Vata causes impaired Indriya functions and leads to symptoms like sharp pain (Shoola), burning sensation (Karapada tala daha), numbness (Karapada Suptata), tingling sensation (Pipeelika sancharam), paresthesia and hyperesthesia, etc. Considering the Ayurvedic concepts of management of Vatika-Paitik disorder, Shodhana, and Shamana Chikitsa have been selected.Virechana as a Shodhana procedure helps to subside both Vataja & Pittaja lakshana like Karapada-Daha (burning sensation), Suptata (Numbness), and Shoola (sharp pain), tingling sensation (Pipeelika sancharam), paresthesia and hyperesthesia. Drug Vidangadi Ghanavati is specifically mentioned for Vataja - Pittaja Prameha treatment.  Because of their rasa, guna, virya, and vipaka, Vidangadi Ghanavati drug ingredients aid in pacifying both Vata and Pitta. Thus, Diabetic neuropathy symptoms will be alleviated. Gokshuradi Guggulu is chosen for diabetic neuropathy due to its diverse therapeutic properties. Guggulu provides anti-inflammatory effects, reducing nerve inflammation and pain, while Gokshura offers adaptogenic and diuretic benefits, improving nerve function and reducing oxidative stress. The formulation also promotes nerve regeneration and strengthens the nervous system. Though clinical evidence is limited, preliminary studies highlight its potential efficacy as a supportive therapy.Though many studies have been carried out both in ayurvedic and contemporary medicine, there is still a need to evaluate certain clinical drugs on various scientific parameters that could be safe, effective, cost-effective & readily available. So, to reduce the burden of disease on society, dependency on analgesics for treatment, and improve the quality of life of patients it’s necessary to research this topic and benefit society.

STUDY DESIGN – The study is proposed to be an Open Label Randomized Double Arm Clinical Trial. The patients with fulfilling diagnostic criteria of Pittavritta Madhumeha (Diabetic Neuropathy) will be taken in two groups. The subject attending the OPD of AIIA will be screened and enrolled in the study following the ethics of the Institute and the selection criteria. STUDY TYPE - Clinical trial (Analytical and Interventional) PURPOSE – Treatment MASKING - Open Label ALIGNMENT – Parallel TIMING- Prospective ENDPOINT -Clinical Efficacy METHOD OF SAMPLE SELECTION – Randomized sampling SAMPLE SIZE – A total no. of 106 patients Pittavritta Madhumeha (Diabetic Neuropathy) will be taken in the proposed clinical trial, divided into 53-53 each in the control and trial groups. SELECTION OF CASES - O.P.D. /I.P.D. wing of Department of Kayachikitsa, All India Institute of Ayurveda based on diagnostic criteria of Pittavritta Madhumeha (Diabetic Neuropathy) NO. of GROUPS - 2 (Group A – TRIAL GROUP, Group B - CONTROL GROUP)

 

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[i] Maiti S, Akhtar S, Upadhyay AK, et al. Socioeconomic inequality in awareness, treatment and control of diabetes among adults in India: Evidence from National Family Health Survey of India (NFHS), 2019–2021. Sci Rep. 2023;13:2971. doi:10.1038/s41598-023-29978-y.

[ii] Dyck PJ, Kratz KM, Karnes JL, Litchy WJ, Klein R, Pach JM, Wilson DM, O’Brien PC, Melton LJ, Service FJ. The prevalence by staged severity of various types of diabetic neuropathy, retinopathy, and nephropathy in a population-based cohort: the Rochester Diabetic Neuropathy Study. Neurology. 1993 Apr;43(4):817-24. [PubMed]

[iii] Jasmine A, GV A, Durai V, et al. Prevalence of peripheral neuropathy among type 2 diabetes mellitus patients in a rural health center in South India. Int J Diabetes Dev Ctries. 2021;41:293–300. doi:10.1007/s13410-020-00885-6.