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CTRI Number  CTRI/2024/04/066373 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 19/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Acupuncture treatment for Diabetes Neuropathy 
Scientific Title of Study   Effect of Electroacupuncture on Sensory Peripheral Nerve Functions in Diabetic Peripheral Neuropathy: A Randomized Controlled Trial. 
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 SYAM KUMAR C P  
Designation  P G SCHOLAR 
Affiliation  INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES 
Address  184/4 INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY, FACULTY BLOCK, GROUND FLOOR, Room No. 2, KAMARAJA NAGAR, CHENGALPATTU

Kancheepuram
TAMIL NADU
603001
India 
Phone  9496284547  
Fax    
Email  drsyamcp@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR N PRABU 
Designation  ASSISTANT MEDICAL OFFICER 
Affiliation  INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES 
Address  184/4 INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY, FACULTY BLOCK, Ground Floor, Room No. 3, DEPARTMENT OF ACUPUNCTURE AND ENERGY MEDICINE, DIVISION III GROUND FLOOR, KAMARAJA NAGAR, CHENGALPATTU

Kancheepuram
TAMIL NADU
603001
India 
Phone  9566351891  
Fax    
Email  drprabubnys91@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR N PRABU 
Designation  ASSISTANT MEDICAL OFFICER 
Affiliation  INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY MEDICAL SCIENCES 
Address  184/4 INTERNATIONAL INSTITUTE OF YOGA AND NATUROPATHY, FACULTY BLOCK, Ground Floor, Room No. 3, DEPARTMENT OF ACUPUNCTURE AND ENERGY MEDICINE, DIVISION III, GROUND FLOOR, KAMARAJA NAGAR, Chennai

Kancheepuram
TAMIL NADU
603001
India 
Phone  9566351891  
Fax    
Email  drprabubnys91@gmail.com  
 
Source of Monetary or Material Support  
International Institute of Yoga and naturopathy Medical Sciences, Faculty Block, Ground Floor, Kamaraj Nagar, Chengalpattu 603001 
 
Primary Sponsor  
Name  Dr Syam Kumar C P 
Address  184/4 International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block, Ground floor, Kamaraj Nagar, Chengalpattu 603001 
Type of Sponsor  Other [Self] 
 
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 
DR C P SYAM KUMAR  International Institute of Yoga and Naturopathy Medical Sciences  184/4, Acupuncture and Energy Medicine Division, Faculty Block, Ground Floor, Room No. 2, Kamaraj Nagar, Chengalpatu
Kancheepuram
TAMIL NADU 		 9496284547

drsyamcp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethical Committe International Institute of Yoga and Naturopathy Medical Sciences Chengalpattu  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, (2) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ELECTROACUPUNCTURE  Insert sterile needles (TX – Pinpai, Single use) bilaterally as follows: 1. ST44 (Neiting) - on the dorsum of the foot, between the second and third toes, 0.5 cun proximal to the margin of the web 2. ST36 (Zusanli) - below the knee, 3 cun inferior and lateral to the apex of the patella 3. ST43 (Xiangu) - on the dorsum of the foot, between the second and third metatarsal bones, in a depression 1 cun proximal to ST44 4. K2 (Rangu) - on the medial side of the foot, distal and inferior to the medial malleolus, in the depression distal and inferior to the navicular tuberosity 5. K3 (Taixi) - in the depression between the medial malleolus and the Achilles tendon, level with the prominence of the medial malleolus 6. BL60 (Kunlun) - behind the ankle joint, in the depression between the prominence of the lateral malleolus and the Achilles tendon 7. SP9 (Yinlingquan) - on the medial side of the lower leg, in a depression in the angle formed by the medial condyle of the tibia and the posterior border of the tibia 8. GB 41 (Zulinqi) - in the depression distal to the junction of the 4th and 5th metatarsal bones, on the lateral side of the tendon of extensor digitorum longus muscle Electrical stimulation should be administered for 20 minutes per sitting, three days a week for eight weeks using a Hwato Electronic Acupuncture instrument with an adjustable pulse frequency between 1 – 100 Hz. The electrical stimulation should be applied to ST44, GB41, UB60, and ST36 during the first four weeks of the study, and ST43, K2, K3, and SP9 during the second four weeks of the study, bilaterally. 
Comparator Agent  Waitlist  the patient will be rested during treatment during the 8-week study. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. After ruling out other potential causes, Diabetic peripheral neuropathy is defined as the existence of symptoms and/or indications of peripheral nerve damage in diabetics.
b. peripheral neuropathy is described as having either (a) altered sensitivity to pain or (b) altered sensitivity to vibration in addition to altered sensitivity to pressure. (10)
2. Patients diagnosed with diabetes for more than 5 years.
3. HbA1C more than 7%
4. Patients who are willing to written informed consent.
5. Patients who are able to understand research procedures and desire to adhere to them for the duration of the study.
 
 
ExclusionCriteria 
Details  1. Diabetic peripheral neuropathy brought on by illnesses other than diabetes, such as alcoholism, chemotherapy, and Vitamin B12 deficiency.
2. Cardiovascular disorder (e.g., arrhythmia) or using pacemakers, or artificial implants.
3. Psychoneurotic causes: epilepsy, depression, panic disorder.
4. Known hypersensitivity reaction after acupuncture treatment or inability to cooperate with acupuncture procedure.
5. Open wound, Scald or burn in Specific Points of intervention.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
NEURO TOUCH(11) (A Validated Neurothesiometer) will be used for measuring the threshold for vibration perception, hot and cold perception, touch perception, and skin temperature before and after a week of intervention sessions and at the end of 8 weeks of intervention.  Baseline, 4th week and 8th week 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcome – VAS (Visual Analog Scale)-based assessment of pain.  Baseline, 4 WEEKS AND 8 WEEKS  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/05/2024 
Date of Study Completion (India) 30/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="1"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Online

  6. For how long will this data be available start date provided 01-05-2024 and end date provided 30-05-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Diabetic peripheral neuropathy (DPN) poses a significant challenge in diabetes management due to its debilitating symptoms and limited treatment options. This study aims to evaluate the efficacy of electroacupuncture in improving sensory peripheral nerve functions in DPN patients. The primary objective is to assess the impact of electroacupuncture at specific acupuncture points on vibration threshold, hot and cold perception, touch sensitivity, and skin temperature. Secondary objectives include evaluating the response to electroacupuncture for neuropathic pain. 


Participants aged 40 to 60 years with a diagnosis of DPN as per the American Diabetic Association criteria, diabetes duration over 5 years, and HbA1C levels above 7% will be enrolled. Exclusion criteria include DPN due to causes other than diabetes, cardiovascular disorders, psychoneurotic causes, hypersensitivity to acupuncture, and open wounds at specific intervention points.


This research will address a critical gap in knowledge regarding the effectiveness of electroacupuncture in DPN management. Findings from this study are expected to provide valuable insights into the potential benefits of electroacupuncture as a non-pharmacological intervention for alleviating DPN symptoms and improving overall quality of life for affected individuals.

 
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