| CTRI Number |
CTRI/2023/02/049934 [Registered on: 21/02/2023] Trial Registered Prospectively |
| Last Modified On: |
01/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of the Homoeopathic Medicine Solidago virgaurea in the treatment of albumin in urine of Diabetic patients |
|
Scientific Title of Study
|
An Open Labelled Prospective Clinical Case Series Study to assess the levels of Microalbuminuria of Diabetic Nephropathy Patients treated with Solidago virgaurea 6CH |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karishma M |
| Designation |
BHMS |
| Affiliation |
Vinayaka Missiosn Homoeopathic Medical College and Hospital ,Salem |
| Address |
ROOM 3d, MEDICAL UNIT OF IV, DEPARTMENT OF PRACTICE OF MEDICINE,OPD BLOCK,VINAYAKA MISSIONS HOMOEOPATHIC
MEDICAL COLLEGE AND HOSPITAL,NH 47,SANKARI MAIN
ROAD,SEERAGAPADI PO
Salem
TAMIL NADU
636308
India |
| Phone |
7810073031 |
| Fax |
|
| Email |
karishma.achu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Venkatesan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vinayaka Missiosn Homoeopathic Medical College and Hospital ,Salem |
| Address |
ROOM 3d, MEDICAL UNIT OF IV, DEPARTMENT OF PRACTICE OF MEDICINE,OPD BLOCK,VINAYAKA MISSIONS HOMOEOPATHIC
MEDICAL COLLEGE AND HOSPITAL,NH 47,SANKARI MAIN
ROAD,SEERAGAPADI PO
Salem
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr H Venkatesan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vinayaka Missiosn Homoeopathic Medical College and Hospital ,Salem |
| Address |
ROOM 3d, MEDICAL UNIT OF IV, DEPARTMENT OF PRACTICE OF MEDICINE,OPD BLOCK,VINAYAKA MISSIONS HOMOEOPATHIC
MEDICAL COLLEGE AND HOSPITAL,NH 47,SANKARI MAIN
ROAD,SEERAGAPADI PO
Salem
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital,NH 47,Sankari main road,Seeragapadi PO,Salem,Tamil Nadu-636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
NH 47,Sankari main road,Seeragapadi PO,Salem,Tamil Nadu-636308 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Central Council for Reseach in Homoeopathy |
61-65,Institutional Area,Opp D Block,Janak Puri,New Delhi 110058 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr H Venkatesan |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Room No;3 D-Dept of Practice of Medicine OPD Unit,Ground Floor,Hospital Block,VMHMCH,NH47,Sankari Main Road,Seeragapadi PO,Salem TAMILNADU
Salem
TAMIL NADU |
9865134561
venkathompath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Solidago virgaurea 6CH |
5 Medicated globules of 30 size will be prescribed orally morning and night for a minimum 60 days before food |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diabetic Nephropathy patients with
ACR value >2.5mg/mmol creatinine in males
ACR value >3.5mg/mmol creatinine in females |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from other renal diseases
2. Gestational diabetic patients
3. Diabetes Mellitus patients with Multi-System Involvement |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of ACR value
Reduction of urine albumin excretion levels, control of blood glucose levels, Improvement of e-GFR |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes mellitus is the main cause of end-stage renal disease. Most cases of diabetes mellitus develop into diabetic nephropathy and albuminuria is seen at the time of diagnosis. Microalbuminuria is a clinical sign that indicates vascular damage in the glomerulus which leads to diabetic nephropathy. Microalbuminuria is estimated by the urinary albumin/creatinine ratio, a significant side effect of type II diabetes mellitus is diabetic nephropathy which is characterized by an increased urine albumin excretion rate which eventually results in end-stage renal disease. Hence diabetes mellitus should be monitored regularly for microalbuminuria. Homeopathic medicines like Helonias, lycopodium, Abroma augusta, Cephalandra indica, Gymnema sylvestre, Syzygium jambolanum, insilin, glycerinum, acid phosphoricum, carbolicum acidum, terebinthinae etc., are some of the homeopathic remedies indicated for diabetes. Solidago is effective in the treatment of diabetic nephropathy as it is indicated for albumin, blood, slime in urine, pain in the region of the kidney and kidneys are sensitive to pressure. These are the details that intended me to assess the microalbuminuria levels in diabetic nephropathy patients treated with Solidago virgaurea 6CH by performing a clinical case series study. |