| CTRI Number |
CTRI/2025/04/085993 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to evaluate the efficacy of Vellarugu Chooranam in Peripheral Neuropathy in Type II Diabtes Mellitus patients |
|
Scientific Title of Study
|
AN OPEN NON-RANDOMIZED SINGLE CENTRIC CLINICAL TRIAL TO EVALUATE THE EFFICACY OF VELLARUGU CHOORANAM IN THE MANAGEMENT OF KARATHAMBA VAATHAM (DIABETIC PERIPHERAL NEUROPATHY) AMONG PATIENTS ATTENDING OPD AT GOVERNMENT SIDDHA MEDICAL COLLEGE HOSPITAL,CHENNAI. |
| 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 R Saranya |
| Designation |
PG Scholar |
| Affiliation |
Department Of Pothu Maruthuvam,Government Siddha Medical College, Arumbakkam,Chennai. |
| Address |
Department Of Pothu Maruthuvam,Government Siddha Medical College, Arumbakkam,Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
6380712060 |
| Fax |
|
| Email |
saranya101rks@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Isabell rafeeda |
| Designation |
Lecturer, Department of UG Pothu Maruthuvam |
| Affiliation |
Department Of Pothu Maruthuvam,Government Siddha Medical College, Arumbakkam,Chennai. |
| Address |
Department Of Pothu Maruthuvam,Government Siddha Medical College, Arumbakkam,Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
9444459047 |
| Fax |
|
| Email |
vrafeeda@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Isabell rafeeda |
| Designation |
Lecturer, Department of UG Pothu Maruthuvam |
| Affiliation |
Department Of Pothu Maruthuvam,Government Siddha Medical College, Arumbakkam,Chennai. |
| Address |
Department Of Pothu Maruthuvam,Government Siddha Medical College, Arumbakkam,Chennai.
Chennai
TAMIL NADU
600106
India |
| Phone |
9444459047 |
| Fax |
|
| Email |
vrafeeda@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College,Arumbakkam,Chennai, Tamilnadu, Pin-600106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
No.6,Anna Arch Road,Arumbakkam,Chennai, Tamilnadu, Pin -600106 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr R Saranya |
Government Siddha Medical College Hospital, Chennai |
No.1, Department of Pothu Maruthuvam,Arumbakkam,Chennai, Tamilnadu,Pin-600106
Chennai
TAMIL NADU |
6380712060
saranya101rks@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Arumbakkam,Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G64||Other disorders of peripheral nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vellarugu Chooranam |
The purified ingredients Vellarugu Samoolam(1 part) & Pinju kadukkai (1/8part) will be taken in above
mentioned quantity, mildly roasted & finely powdered will be sieved well using seiving cloth.2 grams of vellarugu chooranam will be given with lukewarm water for 40 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
If the patients fall under, in any of the following three (2013 WHO Diabetic diagnostic
criteria)Blood sugar fasting more than 126 and equal to or less than 200 mg /dl (or)
Postprandial Blood Sugar more than 200 mg/dl and equal to or less than 350 mg /dl (or).
Glycated hemoglobin (HbA1c) more than 7percentage and less than 13 percentage
Michigan Neuropathy Screening Instrument (MNSI) – Examination score more than or equal to 2.5
considered positive for neuropathy total score out of 5 and MNSI Questionnaires score more than or equal to
7 considered positive for presence of neuropathy total score out of 15.
Patients already under medication for Madhumegam.
Already diagnosed DM patients with clinical symptoms |
|
| ExclusionCriteria |
| Details |
Age more than 60 years
Insulin Dependent Diabetes Mellitus
Autonomic neuropathy
Alcohol-associated neuropathy
Nutritional linked neuropathy
Secondary Thyroid disorder
Uremic neuropathy
Subjects with severe systemic illness
Subjects who are unwilling or unable to comply with the trial protocol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the therapeutic effect of Vellarugu Chooranam for the treatment of
Karathamba vaatham (Diabetic Peripheral Neuropathy) patients on the basis of Michigan
Neuropathy Screening Instrument (MNSI) and HbA1C |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the aldose reductase inhibition assay of the Siddha medicine Vellarugu Chooranam through invitro method |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
09/05/2025 |
| 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
|
Peripheral neuropathies are diseases of the peripheral nervous system that can be divided into
mononeuropathies, multifocal neuropathies, and polyneuropathies . Peripheral Neuropathy may be
due to various cause Hereditary, Metabolic causes, Nutritional Deficiency,Connective tissue
disorders, Infection, Toxins and Malignancy . The first symptoms tend to be sensory and consists of
tingling, prickling, burning or bandlike dysesthesias in the balls of the feet or tip of the toes or in
general distribution over the soles .The tingling sensation started distally and limited in the “Glove
and stocking” distribution. Diabetic neuropathy (DN) is a common disorder and is defined as signs
and symptoms of peripheral nerve dysfunction in a patient with diabetes mellitus (DM) in whom
other causes of peripheral nerve dysfunction have been excluded. There is a higher prevalence of DM
in India (4.3%) probably Asian Indians are more prone for insulin resistance and cardiovascular
mortality. India ranks second worldwide with a prevalence of 10.5–32.2% in the type 2 diabetes
population (T2DM) and 26% to 51% of diabetic peripheral neuropathy (DPN). In epidemiological
studies from India showed wide prevalence varying from 5 to 2400 per 10,000 population indifferent community studies. Siddha medicine “Vellarugu Chooranam”mentioned in Siddha Literature for the treatment of “Karathamba
vaatham” (Diabetic Peripheral Neuropathy) patients is considered to evaluate the efficacy using Michigan Screening instrument. |