| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator 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. |