| CTRI Number |
CTRI/2024/05/067519 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To study the effect of Vanadium Metallicum in 12 homoeopathic centesimal potency in cases of type 2 diabetes mellitus |
|
Scientific Title of Study
|
In-vitro analysis of anti-oxidant potential of vanadium metallicum 12c and validating through open label randomized control trial in Type ii Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushma Naigotriya |
| Designation |
Post graduatee trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy department of homoeopathic materia medica OPD number 18 GE Block Salt lake sector III bidhan nagar West Bengal India
GE Block sector III salt lake bidhan nagar West Bengal India
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
6265655857 |
| Fax |
|
| Email |
sushmanaigotriya0984@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kumaravel. V |
| Designation |
Associate professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
NIH Residential Quarter JC Block
Salt lake sector III Kolkata West Bengal India
GE Block Salt lake sector III Kolkata West Bengal India
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
6265655857 |
| Fax |
|
| Email |
drkumaravelnih@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
National Institute of Homoeopathy |
| Designation |
Post graduatee trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy department of homoeopathic materia medica OPD number 18 GE Block Salt Lake Sector III bidhan nagar West Bengal 700106
National Institute of Homoeopathy department of homoeopathic materia medica OPD number 18 GE Block Salt lake sector III bidhan nagar West Bengal India 700106
North Twentyfour Parganas
WEST BENGAL
Sushma Naigotriya
India |
| Phone |
06265655857 |
| Fax |
|
| Email |
sushmanaigotriya0984@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of Homoeopathy GE Block sector 3 salt lake bidhan nagar West Bengal,India 700106 |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy department of homoeopathic materia medica OPD number 18 GE Block Salt lake sector III bidhan nagar West Bengal India 700106 |
| 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 |
| Sushma Naigotriya |
National Institute of Homoeopathy |
National Institute of Homoeopathy department of homoeopathic materia medica OPD number 18 GE Block Salt lake sector III bidhan nagar West Bengal India 700106
North Twentyfour Parganas
WEST BENGAL |
6265655857
sushmanaigotriya0984@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualized homoeopathic medicine |
According to the homoeopathic principles individualized medicine to be selection after complete case taking and administered in patients of type 2 diabetes mellitus and will compare its efficacy in comparison with vanadium metallicum |
| Intervention |
vanadium 12c |
Antioxidants are well recognized for lowering radioactive oxygen species (ROS) induced oxidative stress, which contributes to the onset of diabetes and its associated complications. Vanadium metal complexes aid in the reduction of serum glucose levels in animals by mimicking insulin. They function as inhibitors of PTP-1B (protein tyrosine phosphatase) enzyme overexpression. Vanadium is an oxygen carrier and a catalyzer, hence its use in wasting diseases. Numerous studies confirm its effectiveness of vanadium in treating diabetes but no study have explored its anti-diabetic effects in homoeopathy so i am doing this study on patients of type 2 diabetes mellitus in 12 centesimal potency for 6 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age groups 30-70 of both sex and of all Religion.
FBS 125- 150 mg/dl.
PPBS 200- 300 mg/dl.
HbA1C 6.5- 8 %
Out of above 3 any two.
Patient willing to give written consent for participating in the study and complete follow-up during study.
Patients who are able to read Bengali/English/Hindi
|
|
| ExclusionCriteria |
| Details |
Patients age below 30 and above 70.
Patients having severe complications like hypoglycaemia, retinopathy, neuropathy, diabetic foot, malignancy, severe cardiac disorders,
HbA1C above 8,
FBS above 150 mg/dl,
PPBS above 300mg/dl or any other comorbidities.
Immunocompromised patient.
Patient suffering from any severe psychiatric illness.
Patients not willing to give written consent.
Patients not willing to undergo any investigation, if needed.
Pregnant and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the Fasting Blood Sugar before and after treatment |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| antioxidant values of vanadium met 12 C |
within study period 6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2024 |
| Date of Study Completion (India) |
01/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Many studies have shown that free radicals are elevated in diabetes mellitus which further complicate the case so vanadium is an antioxidant metal and many studies shows that it has insulin mimicking properties thus helpful in diabetes but no study paper available in homoeopathy that proves its efficacy so ill screen patients of diabetes mellitus type ii in age group of 30-70 years with fasting blood sugar 150-200mg/dL or HbA1c 6.5-8% with no other complication of diabetes or any other comorbidities for one intervention group 40 patients i’ll give vanadium 12c and other 40 patient will take individualized homoeopthic treatment those who are attending NIH OPD & IPD kolkata. study period will be 18 months and intervention period will be 6 months. After study i’ll compare the change in FBS in both vanadium and individualised homoeopathic medicine efficacy. patient will be enrolled after informed consent only available in hindi english and bengoli languages . if any negative outcomes appears for detoriation of health condition of patients then study will be stopped and necessary measures for the betterment of patient will be taken . |