| CTRI Number |
CTRI/2021/12/039033 [Registered on: 29/12/2021] Trial Registered Prospectively |
| Last Modified On: |
28/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trail on managment of Diabetes Mellitus by using Uranium Nitricum |
|
Scientific Title of Study
|
A Single blind clinical study to assess the action of Uranium Nitricum in Type 2 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 |
Perla Sai Bhuvaneshwari |
| Designation |
Doctor Pg Scholar |
| Affiliation |
B.V.D.U.Homeopathic Medical College and Hospital Dept. of post Graduate and Research Centre |
| Address |
Department of Homoeopathic materia Medica 3rd Floor
B.V.D.U Homoeopathic Medical College and Homoeopathic Hospital, Department of post graduate and research centre Pune-43
Pune
MAHARASHTRA
411046
India |
| Phone |
8105181939 |
| Fax |
|
| Email |
p.saibhuvana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sheetal Ajit Patil |
| Designation |
M.D.(Hom)Associate Professor |
| Affiliation |
B.V.D.U.Homeopathic Medical College and Hospital Dept. of post Graduate and Research Centre |
| Address |
Department of Homoeopathic materia Medica 3rd Floor
B.V.D.U Homoeopathic Medical College and Homoeopathic Hospital, Department of post graduate and research centre Pune-43
Pune
MAHARASHTRA
411046
India |
| Phone |
9850545835 |
| Fax |
|
| Email |
Sheetal.Patil@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Perla Sai Bhuvaneshwari |
| Designation |
Doctor Pg Scholar |
| Affiliation |
B.V.D.U.Homeopathic Medical College and Hospital Dept. of post Graduate and Research Centre |
| Address |
Department of Homoeopathic materia Medica 3rd Floor
B.V.D.U Homoeopathic Medical College and Homoeopathic Hospital, Department of post graduate and research centre Pune-43
Pune
MAHARASHTRA
411046
India |
| Phone |
8105181939 |
| Fax |
|
| Email |
p.saibhuvana@gmail.com |
|
|
Source of Monetary or Material Support
|
| B.V.D.U.Homeopathic Medical College and Hospital Dept. of post Graduate and Research Centre |
|
|
Primary Sponsor
|
| Name |
Perla Sai Bhuvaneshwari |
| Address |
B.V.D.U.Homeopathic Medical College and Hospital Dept. of post Graduate and Research Centre |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Perla Sai Bhuvaneshwari |
B.V.D.U.Homeopathic Medical College and Hospital Dept. of post Graduate and Research Centre |
Department of Homoeopathic materia Medica 3rd Floor
B.V.D.U Homoeopathic Medical College and Homoeopathic Hospital, Department of post graduate and research centre Pune-43
Pune
MAHARASHTRA |
8105181939
p.saibhuvana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVDUHMC-INSTITUTIONAL ETHICS COMITTEE |
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 |
nil |
nil |
| Intervention |
URANIUM NITRICUM |
Potentised homoeopathic
medicine in the form of pills or powder.Dose: The final selected remedy based on the individual totality will be prescribed in appropriate doses based on the susceptability.Route of
Administration: oral
Selection of potency:The drug will be administered in various potencies as per the need of patient. Duration: 3 months.Frequency: Follow up will be taken every 8-15 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient who fulfilling the case definition.
2. Patient who are willing to take treatment and will co-operate with regular follow up.
3. HbA1c level of patient should be above 6.5 %-9%
4. Patients with pre-diagnosed case of diabetes mellitus by physician.
5. Patients of both sexes.
6. Patients who signed the consent form.
7. Diabetes seen in post covid patients. |
|
| ExclusionCriteria |
| Details |
1. Patient who has not the signed consent.
2.Patients needed with emergency medical intervention with complication of systemic
diseases.
3. Patients with diabetic complications will not be included.
4. Gestational diabetes is excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To achieve improvement by accessing the Blood sugar levels upon giving Uranium Nitricum.
|
Improvement by accessing the Blood sugar levels with follow up taken after 2 weeks of medicine prescribed for 3 months with Hba1c recorded at the starting and at end of the study . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To control the condition by accessing their Blood sugar levels.
|
Blood Sugar level of the patient using Glucometer is monitored as per necessity of the case every 2 weeks. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
08/01/2022 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes Mellitus (DM) refers to a metabolic disorders that share phenotype of hyperglycemia.The worldwide prevalence of DM has risen dramatically over the past two decades,Homeopathic treatment is a holistic approach, in which Uranium Nitricum is one of the remedies that has the indications on kidneys as the main field and chronic renal degeneration, with albuminuria, or glycosuria with ascites, are as marked features. so, through this way we can assess the effectivness of Uranium nitricum in Diabetes Mellitus with follow up taken every 8-15 days after prescribing medicine and noting their glucose levels as per the need. |