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Clinical Trials/CTRI/2024/03/064317
CTRI/2024/03/064317Active, not recruitingNot Applicable

Occurrence of diabetic peripheral neuropathy and its relationship with Prakriti among type 2 diabetic patients - A cross-sectional study

Ayurswasthya Yojana, Centre of excellence Scheme, Ministry of Ayush, Govt of India1 site in 1 country400 target enrollmentStarted: March 25, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
400
Locations
1
Primary Endpoint
i. Estimation of occurrence of diabetic peripheral neuropathy among type 2 diabetic patients

Study Overview

Brief Summary

Diabetes mellitus (DM) is a common cause of neuropathy worldwide affecting approximately 30% of diabetic patients. Diabetic neuropathy is a heterogeneous group of conditions that affects different parts of the nervous system and presents with diverse clinical manifestations.1 Peripheral Neuropathy is one of the most common micro vascular complications of Diabetes Mellitus characterized by paraesthesia, significant deficits in tactile sensitivity, vibration sense, lower limb proprioception and kinesthesia.2In India, the occurrence of diabetic peripheral neuropathy (DPN) varies from 9.6% to 78% in different populations.3

According to Ayurveda, the description of disease Prameha has similarity to the description of Diabetes diseases and symptoms of DPN are scattered in the Purvaroopa (prodromal symptoms) and Upadrava (complications).4 Prakupita Vata (aggravated Vata, one of the regulatory factors of the body responsible for movement and cognition*)* with the other Doshas (regulatory factors of the body) and Dhatukshayaja Avasta (a state of depletion of  body tissues) results in the manifestation Upadrava(complications) and exhibit the symptoms such as Suptata (numbness) due to Kapha Dosha (one of the regulatory factors of the body responsible for body fluids and keeping the body constituents). Daha and Paridhupana (burning sensation) are attributed to Pitta Dosha (one of the regulatory factors of the body that is, responsible for digestion and metabolism). Kampa (tremor/vibrations), Shoola (pain), Dourbalya (weakness) undoubtedly due to Vata Dosha (one of the regulatory factors of the body responsible for movement and cognition).5,6 These symptoms can be closely correlated to the symptoms of diabetic peripheral neuropathy.

Neuropathy is a challenging condition to all the system of medicine to treat, as its pathology is at the micro vessels and difficulty for the medicine to reach the site due to the obstruction for the blood flow.2 The problem of DPN demands the application of the concept of secondary prevention through early diagnosis and treatment because available evidence suggests that the presence of DPN among patients with diabetes leads to reduced quality of life, mainly attributable to the morbidity and mortality associated with DPN. Foot disorders remain a major source of morbidity among patients with diabetic peripheral neuropathy. The adverse effects of peripheral neuropathy are compounded by poor foot hygiene, improper footwear, and frequent barefoot walking, in such circumstances complications of foot infections, gangrene and amputation are common causes of hospital admissions. Hence screening for DPN in the clinical practice using a simple objective tool is essential, as the detection of the various soft and subtle signs of DPN at the earliest could minimize the damaging effects of this serious but manageable microvascular complication and in turn improve the quality of life of such patients.3

Various studies have shown that there are a number of socio-demographic factors and comorbidities can influence the manifestation and progression of DPN. Knowledge of risk factors for DPN is clinically useful, because it offers the opportunity for delay and prevention of this complication. Some risk factors are modifiable and should receive the clinician’s attention. 7,8 Hence it is highly relevant to identify and determine the risk factors associated with DPN among cross sectional population in Bengaluru.

Prakriti which is a basic term in Ayurveda referring to a physical and psychological feature of human beings unchangeable from birth to death will be assessed in the patients of Diabetes to explore its association and probable risk factors involved. In holistic approach, Ayurveda classifies human beings based on the seven different Sharirika Prakriti, namely, Vata, Pitta, Kapha, Vata-Pitta, Pitta-Kapha, Kapha-Vata and Tridosha–Vata Pitta Kapha corresponding to three Dosha, Vata, Pitta and Kapha. Each of the Dosha has their own phenotypic characteristics corresponding to certain factors such as season, diet, age, environment & activity. Imbalance in this cause disease. These Prakriti are particular and specific to each individual, which are determined during fertilization and remains unchanged throughout life.Prakriti assessment plays a significant role in the diagnosis and judgement of prognosis of the diseases.9 It is also a known fact that if Vikara Prakriti (nature of disease) and Prakrita Prakriti (normal state) are similar then disease is difficult to manage (Kashtasadhya) and easy to manage (Sukhasadhya) if disease and Prakriti are of different origin.10 Due to its complexity, yet prospective bearings upon preventive and curative aspect Prakriti examination have attracted significant attention since antiquity. The recent advances in the fields of genomics, personalized medicine, and Ayurveda have motivated many researchers to look at the relationship between Prakriti (phenotype-based Ayurveda constitution) and various objective biological parameters.11 Hence this study is planned to explore the association between these two domains (Diabetic neuropathy & Prakriti). This will try to explore whether diabetic peripheral neuropathy is prominent in any specific type of Dosha Prakriti, as well as how its symptoms express in connection to Prakriti. Thus, this study may significantly contribute to improve the prognosis by early diagnosis, prevention & management.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Clinically diagnosed adult cases of any gender diagnosed with type 2 diabetes (with or without treatment) ii.
  • Subjects who agree to participate in the study and submit a written informed consent form.

Exclusion Criteria

  • Subject diagnosed with type 1 Diabetes Mellitus ii.
  • Subject on systemic or oral steroids iii.
  • Pregnant /lactating women iv.
  • Subjects with a current diagnosis of malignancy or in the last five years or who has undergone chemotherapy v.
  • Subjects with any other neurological diseases or nerve dysfunction that may interfere with the study or receiving any treatment that might influence nerve function vi.
  • Subjects with history /current diagnosis of vitamin B12 deficiency/megaloblastic anaemia vii.
  • Subjects with history/current diagnosis of hypothyroidism viii.
  • Subjects with history/current diagnosis of autoimmune diseases ix.
  • Any other condition that the Investigator thinks may jeopardize the safety of the subject.

Outcomes

Primary Outcomes

i. Estimation of occurrence of diabetic peripheral neuropathy among type 2 diabetic patients

Time Frame: One time assessment at enrolment

ii. Relationship between diabetic peripheral neuropathy (DPN) and Prakriti among type 2 diabetic patients

Time Frame: One time assessment at enrolment

Secondary Outcomes

  • Relationship between age and diabetic peripheral neuropathy among type 2 diabetic patients(One time assessment at enrolment)
  • ii. Relationship between gender and diabetic peripheral neuropathy among type 2 diabetic patients(One time assessment at enrolment)
  • iii. Relationship between family history and diabetic peripheral neuropathy among type 2 diabetic patients(One time assessment at enrolment)
  • iv. Relationship between glycosylated hemoglobin and diabetic peripheral neuropathy among type 2 diabetic patients(One time assessment at enrolment)
  • v. Relationship between chronicity of diabetes and diabetic peripheral neuropathy among type 2 diabetic patients(One time assessment at enrolment)
  • vi. Relationship between body mass index (BMI) and diabetic peripheral neuropathy among type 2 diabetic patients(One time assessment at enrolment)
  • vii. Relationship between addictions and diabetic peripheral neuropathy among type 2 diabetic patients(One time assessment at enrolment)
  • vii. Determination and classification of the risk for diabetic foot ulceration and amputation among type 2 diabetic patients(One time assessment at enrolment)

Investigators

Sponsor
Ayurswasthya Yojana, Centre of excellence Scheme, Ministry of Ayush, Govt of India
Sponsor Class
Government funding agency
Responsible Party
Principal Investigator
Principal Investigator

Dr Vidyashree Anchan Vitthal

Central Ayurveda Research Institute

Study Sites (1)

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