| CTRI Number |
CTRI/2025/10/096329 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of uranium nitricum in the treatment of type II Diabetes Mellitus |
|
Scientific Title of Study
|
Effectiveness of Uranium nitricum in centesimal potency using Hering's Guiding Symptoms for the treatment of type II Diabetes Mellitus - A single arm pre and post interventional 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 Fazal Akhtar |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD NO 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Saltlake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
7007343012 |
| Fax |
|
| Email |
akhtarfazal523@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chintamani Nayak |
| Designation |
Associate Professor, HOD |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD NO 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Saltlake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chintamani Nayak |
| Designation |
Associate Professor, HOD |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD NO 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Saltlake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433161854 |
| Fax |
|
| Email |
drcnayak@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Block GE, Sector 3, Saltlake, Kolkata, 700106
|
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block GE, Sector 3, Saltlake, Kolkata, 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 |
| Dr Fazal Akhtar |
National Institute of Homoeopathy |
OPD NO 18, Department of Homoeopathic Materia Medica, National Institute of Homoeopathy, Block GE, Sector 3, Salt lake, Kolkata, 700106
Kolkata
WEST BENGAL |
7007343012
akhtarfazal523@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Homoeopathy - Institutional Ethical Committee |
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 |
Not applicable |
Not applicable |
| Intervention |
Uranium nitricum in Centesimal potency for 6 months |
Medicine will be prescribed in Centesimal potency, according to Homoeopathic principles regarding dose and repetition. Medicine will be administered for a period of 6 months. Data will be recorded at baseline, 3 months and 6 months for each individual patient. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All religion and all socio-economic status
More or equal to eight out of twelve symptoms of Uranium nitricum from Hering’s
Guiding Symptoms of Our Materia Medica
HbA1C 6.5 – 8 %
Diagnosed case of type II Diabetes Mellitus
Participant willing to give written consent for participating in the study and complete
follow-up during study
Participants who are able to understand Bengali/English/Hindi |
|
| ExclusionCriteria |
| Details |
Participants having severe complications like hypoglycaemia, retinopathy, neuropathy,
diabetic foot, malignancy, severe cardiac disorders and other systemic disorders
Immunocompromised participant
Participant suffering from any severe psychiatric illness
Participants not willing to undergo any investigation, if needed
Pregnant and lactating mothers
Participants using insulin for glycemic control |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HbA1c levels |
At baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DQOL-Brief Clinical Inventory (BCI) |
At baseline, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
05/11/2025 |
| 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="6"
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
|
DIABETES MELLITUS TYPE II ICD-11 DIAGNOSIS CODE-5A11 Diabetes mellitus is a long-term metabolic disease characterized by elevated protein breakdown, hyperglycaemia, acidosis, ketosis, and glycosuria. Degenerative changes in the blood vessels, retina, kidney, and neurological system might exacerbate it often. Patients who are suffering from type II Diabetes Mellitus and registered in OPD and IPD of National Institute of Homoeopathy, Kolkata and fulfilling the criteria of inclusion and exclusion will be taken as sample of this study. Symptoms of patients will be matched with the selected symptoms from Hering’s Guiding Symptoms and Uranium nitricum will be prescribed if matched symptoms are more than or equal to eight. Dose and frequency of the medicine will be as per the Homoeopathic principles. Medicine will be prescribed in centesimal potency. Uranium nitricum is proven and established drug, included in Homoeopathic Pharmacopoeia of India (HPI). Mean changes in HbA1c values and DQOL-Brief Clinical Inventory (BCI) will be assessed at baseline, 3 months and 6 months, to see the correlation, whether with the change in HbA1c values and DQOL-BCI after using Uranium nitricum.
|