CTRI

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CTRI Number

CTRI/2025/07/090638 [Registered on: 10/07/2025] Trial Registered Prospectively

Last Modified On:

09/07/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Homeopathy

Study Design

Non-randomized, Active Controlled Trial

Public Title of Study

Homoeopathic Medicine For Management Of Diabetic Peripheral Neuropathy

Scientific Title of Study

Role Of Individualized Homoeopathic Medicines In The Management Of Diabetic Peripheral Neuropathy Using Toronto Clinical Scoring System: A Clinical 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 Priyanka Rathod
Designation	PG Scholar
Affiliation	Jawaharlal Nehru Homoeopathic Medical College
Address	Jawaharlal Nehru Homoeopathic Medical College, Department Of Practice Of Medicine, Post Graduation Division, Parul University, P.O. Limda, Ta. Waghodia, Dist. Vadodara, Vadodara, Gujarat Vadodara GUJARAT 391760 India
Phone	9664579265
Fax
Email	2304082040004@paruluniversity.ac.in

Details of Contact Person
Scientific Query

Name	Dr Kirtida Desai
Designation	Professor, Practice Of Medicine
Affiliation	Jawaharlal Nehru Homoeopathic Medical College
Address	Jawaharlal Nehru Homoeopathic Medical College, Department Of Practice Of Medicine, Post Graduation Division, Parul University, P.O. Limda, Ta. Waghodia, Dist. Vadodara, Vadodara, Gujarat Address Vadodara GUJARAT 391760 India
Phone	9574424363
Fax
Email	kirtida.desai@paruluniversity.ac.in

Details of Contact Person
Public Query

Name	Dr Kirtida Desai
Designation	Professor, Practice Of Medicine
Affiliation	Jawaharlal Nehru Homoeopathic Medical College
Address	Jawaharlal Nehru Homoeopathic Medical College, Department Of Practice Of Medicine, Post Graduation Division, Parul University, P.O. Limda, Ta. Waghodia, Dist. Vadodara, Vadodara, Gujarat Address Vadodara GUJARAT 391760 India
Phone	9574424363
Fax
Email	kirtida.desai@paruluniversity.ac.in

Source of Monetary or Material Support

Jawaharlal Nehru Homoeopathic Medical College And Hospital, Parul University, Limda, Waghodia, Vadodara, Gujarat, India, 391760

Primary Sponsor

Name	Jawaharlal Nehru Homoeopathic Medical College And Hospital
Address	Jawaharlal Nehru Homoeopathic Medical College, Department Of Practice Of Medicine, Post Graduation Division, Parul University, P.O. Limda, Ta. Waghodia, Dist. Vadodara, Vadodara, Gujarat
Type of Sponsor	Private medical college

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 Priyanka Rathod	Jawaharlal Nehru Homoeopathic Medical College And Hospital	Department Of Practice Of Medicine, Room No. 110, Jawaharlal Nehru Homoeopathic Medical College, Parul University, Limda, Waghodia, Vadodara, Gujarat, India, 391760. Vadodara GUJARAT	9664579265 2304082040004@paruluniversity.ac.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Jawaharl Nehru Homoeopathic Medical College, Institutional Ethics Committee For Human Research	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: G63\|\|Polyneuropathy in diseases classified elsewhere,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Individualized Homoeopathic Medicines With Physiotherapy	Individualized Homoeopathic Medicines Will Be Person Having Diabetic Peripheral Neuropathy After Evaluation By Toronto Clinical Scoring System On The Basis Of Strict Homoeopathic Principles. Administration Of The Medicines Will Follow A Sublingual Route. A Suitable Potency(30/200/1M) Will Be Prescribed As Per The Necessity Of The Case. Follow Up Will Be Taken After 15 Days With Minimum 6 Follow Up Or As And When Required. Repetition Of The Dose Of Homoeopathic Medicine Will Be Done As Per Requirement Of The Case. The Dose Will Be Administered And Evaluated Until The Disappearance Of The Symptoms Of The Diabetic Peripheral Neuropathy. Total Duration Intervention Will Be 6 Months And Total Duration Of Study Will Be 1 Year Respectively.
Comparator Agent	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	1. Sample Of Both Sexes Aged Above 18 Years Will Be Taken. 2. Newly And Pre Diagnosed Cases Of Diabetic Peripheral neuropathy. 3. Having Clinical Features Such As Numbness In The Feet And Burning Sensation In The Feet Are Included In This Study. 4. Patient Having Consent For The Study.

ExclusionCriteria

Details

1. Patient Suffering From Others Severe Systemic Diseases Like Chronic Kidney Disease, Coronary Artery Disease, Etc.
2. Advanced And Irreversible Pathological Cases Which Require Immediate Medical Attention.
3. Diabetic Peripheral Neuropathy In Pregnant And Lactating Women.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Other

Blinding/Masking

Participant Blinded

Primary Outcome

Outcome	TimePoints
Role Of Individualized Homoeopathic Medicines In The Management Of Diabetic Peripheral Neuropathy Using Toronto Clinical Scoring System	Follow Up To Be Done After 15 Days, With Minimum 6 Follow Up Or As And When Required

Secondary Outcome

Outcome	TimePoints
To Check And Verify The Most Common Age Group Affected By Diabetic Peripheral Neuropathy. To Check Out Most Common Causes Responsible For Diabetic Peripheral Neuropathy	12 Months

Target Sample Size

Total Sample Size="43"
Sample Size from India="43"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

21/07/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

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

The Title Of My Research Is:

"Role Of Individualized Homoeopathic Medicines In The Management Of Diabetic Peripheral Neuropathy Using Toronto Clinical Scoring System: A Clinical Study"

Outline Of The Procedure :

Volunteer Patient Who Are Present With Clinical Features Of Diabetic Peripheral Neuropathy Will Be Recruited From The OPDs Of JNHMCH. The Study Is Designed As A Non-Randomized ,Single-Blind Controlled Trail.

1.Case Taking And Diagnosis:

Case Taking Will Follow The Hahnemannian Schema.

The Diagnosis Will Be Confirmed After RBS, FBS, PP2Bs, HbA1c And Vitamin B12.

2.Number Of Samples:

43 Cases: Patients Will Receive Individualized Homoeopathic Medicines.

3.Assessment And Follow-Up:

The Functional Outcomes Of The Patients Will Be Assessed Using The Toronto Clinical Scoring System.

Follow-Ups Will Be Conducted Every 15 Days, With A Total Of Six Follow-Ups Or As Clinically Required.

A Final Assessment Carried Out After Completing The Follow-Up Period.

Response Will Be Analyzed Into 4 Criteria

Mild Improvement: Toronto Clinical Score Transformed From 8 to 2 Which Indicates Mild Improvement.

Moderate Improvement: Toronto Clinical Score Transformed From 11 To 9 Which Indicates Moderates Improvement .

Significant Improvement: Toronto Clinical Score Transformed From 18 To 12 Which Indicates Significant Improvement.

No Improvement: Toronto Clinical Score Transformed Score 1 Or 0 Which Indicates No Improvement.