| CTRI Number |
CTRI/2024/05/067145 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment of Hydronephrosis |
|
Scientific Title of Study
|
CLINICAL UTILITY OF BOERICKE’S MATERIA MEDICA IN
CASE OF HYDRONEPHROSIS. |
| 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 Dinesh Chand |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital,Lucknow. |
| Address |
Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,Gomti Nagar, Lucknow, Uttar Pradesh- 226010
Lucknow UTTAR PRADESH 226010 India |
| Phone |
7452804634 |
| Fax |
|
| Email |
drdineshchand627@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nutan Sharma |
| Designation |
Reader |
| Affiliation |
State National Homoeopathic Medical College and Hospital,Lucknow |
| Address |
Department of Practice of Medicine , State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,Gomti Nagar, Lucknow, Uttar Pradesh- 226010
Lucknow UTTAR PRADESH 226010 India |
| Phone |
8178562292 |
| Fax |
|
| Email |
drnutansharma@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dinesh Chand |
| Designation |
Postgraduate trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital,Lucknow |
| Address |
Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,Gomti Nagar, Lucknow, Uttar Pradesh- 226010
Lucknow UTTAR PRADESH 226010 India |
| Phone |
7452804634 |
| Fax |
|
| Email |
drdineshchand627@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College and Hospital,Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Dinesh Chand |
| Address |
Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,Gomti Nagar, Lucknow, Uttar Pradesh- 226010 |
| 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 |
| Dr Dinesh Chand |
State National Homoeopathic Medical College and Hospital,Lucknow. |
Department of Homoeopathic Materia Medica, State National Homoeopathic Medical College and Hospital, 1-Viraj Khand,Gomti Nagar, Lucknow, Uttar Pradesh- 226010 Lucknow UTTAR PRADESH |
7452804634
drdineshchand627@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee of State National Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N133||Other and unspecified hydronephrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic medicine |
Intervention is planned as administering individualized homoeopathic medicine to a group of 30 patients suffering from Benign prostatic hyperplasia after detailed case taking and with the help of Boericke’s materia medica. Individualized homoeopathic medicine will be given in varying potencies of centesimal scale depending upon the susceptibility of the patient. Each dose shall consist of 4-5 globules of cane sugar medicated with single medicine(preserved in 90%v/v ethanol) to be taken orally on an empty stomach. Dosage and repetition will depend upon the individual requirement of the cases. The duration of the study will be for 6 months. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient of age between 25 years to 70 years and of both sexes.
2. Patient suffering from Hydronephrosis who are willing to give consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patient of age below 25 years.
2. Patient suffering from congenital anomaly.
3. Any other condition requiring emergency or surgical intervention.
4. Patient unwilling for inclusion in the study and those who are not able to come for follow-up. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and analyse the difference in the Hydronephrosis Severity Score before and after 6 months of treatment to know the utility of individualized homoeopathic medicine. |
12 weeks, 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess changes in the quality of life of the patient at baseline and after 6 months of treatment by comparing the changes in the Hydronephrosis Severity Score. |
12 weeks, 24 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
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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
|
This is a prospective, single arm, open label, interventional clinical study. Hydroureter and hydronephrosis are common entities encountered in primary care medicine, emergency medicine as well as nephrology and urology practices. Hydronephrosis is defined as dilatation and distension of the renal collecting system of one or both kidneys due to obstruction of urine outflow distal to the renal pelvis (i.e., ureter, urinary bladder, and urethra). Hydronephrosis remains the most challenging renal disorder with a high burden of disease. Symptomatic early-stage hydronephrosis urgently needs to be identified and defined, as efficient early-stage case finding and diagnosis in primary care would enable health-care providers to proactively and substantially reduce the burden of disease through proper management including structured education, prevention of other renal disease like renal cyst, addressing lifestyle-related risk factors for disease progression. The aim of this study is to assess the clinical utility of individualized homoeopathic medicine in the management of cases of hydronephrosis by using Boericke’s materia medica. A total number of 30 patients suffering from hydronephrosis & fulfilling the eligibility criteria will be selected from OPD of SNHMC.Data will be collected on the basis of detailed case-taking from patient , physician’s observation and calculation of Hydronephrosis severity score. Outcome will be assessed at baseline and every month up to 6months.Data obtained after the management of 6 months will be analyzed to draw the inference using appropriate statistical tools. |