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CTRI Number  CTRI/2024/03/064317 [Registered on: 18/03/2024] Trial Registered Prospectively
Last Modified On: 09/05/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Occurrence of Peripheral neuropathy in patients of Type 2 Diabetes 
Scientific Title of Study   Occurrence of diabetic peripheral neuropathy and its relationship with Prakriti among type 2 diabetic patients - A cross-sectional study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vidyashree Anchan Vitthal 
Designation  Research Officer 
Affiliation  Central Ayurveda Research Institute 
Address  Room no 5, Ground floor, Hospital wing, 12 Uttarahalli Manavarthe Kaval Kanakapura Main Road Thalaghattapura post

Bangalore
KARNATAKA
560109
India 
Phone  8971859797  
Fax    
Email  dr.anchan88@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vidyashree Anchan Vitthal 
Designation  Research Officer 
Affiliation  Central Ayurveda Research Institute 
Address  Room No 5, Ground floor, Hospital wing, No.12 Uttarahalli Manavarthe Kaval Kanakapura Main Road Thalaghattapura post


KARNATAKA
560109
India 
Phone  8971859797  
Fax    
Email  dr.anchan88@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vidyashree Anchan Vitthal 
Designation  Research Officer 
Affiliation  Central Ayurveda Research Institute 
Address  Room No 5, Ground floor, Hospital wing, No. 12 Uttarahalli Manavarthe Kaval Kanakapura Main Road Thalaghattapura post


KARNATAKA
560109
India 
Phone  8971859797  
Fax    
Email  dr.anchan88@gmail.com  
 
Source of Monetary or Material Support  
Centre of excellence Scheme, Ayurswasthya Yojana under Minisstry of Ayush, Govt of India 
 
Primary Sponsor  
Name  Ayurswasthya Yojana, Centre of excellence Scheme, Ministry of Ayush, Govt of India 
Address  Ministry of Ayush, Ayush Bhawan, B Block, GPO Complex, INA, New Delhi – 110023 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrVidyashree Anchan Vitthal  Central Ayurveda Research Institute, Bengaluru  OPD No 16, Ground floor, Hospital wing, No.12 Uttarahalli Manavarthe Kaval Kanakapura Main Road Thalaghattapura post Bengaluru-560109
Bangalore
KARNATAKA 
8971859797

dr.anchan88@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ayurveda Research Institute, Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E114||Type 2 diabetes mellitus with neurological complications. Ayurveda Condition: PRAMEHA-UPADRAVAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-NIL
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  i. 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.
 
 
ExclusionCriteria 
Details  i. 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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
i. Estimation of occurrence of diabetic peripheral neuropathy among type 2 diabetic patients
ii. Relationship between diabetic peripheral neuropathy (DPN) and Prakriti among type 2 diabetic patients  
One time assessment at enrolment 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/03/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.

 
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