| CTRI Number |
CTRI/2022/06/043180 [Registered on: 13/06/2022] Trial Registered Prospectively |
| Last Modified On: |
11/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to verify the symptoms of Homoeopathic medicine Epigaea Repens in cases of urolithiasis |
|
Scientific Title of Study
|
An Interventional Study To Evaluate The Effectiveness Of Epigaea Repens In Cases Of Urolithiasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Komal Yadav |
| Designation |
PG Student |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Materia Medica
Dr MPK Homoeopathic Medical College Hospital and Research Centre a constituent college of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9929725886 |
| Fax |
|
| Email |
raokomal894@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Materia Medica
Dr MPK Homoeopathic Medical College Hospital and Research Centre a constituent college of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9785835468 |
| Fax |
|
| Email |
Jyotisharmasky11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Yadav |
| Designation |
PG Student |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Materia Medica
Dr MPK Homoeopathic Medical College Hospital and Research Centre a constituent college of Homoeopathy University Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9929725886 |
| Fax |
|
| Email |
raokomal894@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Girendra Pal Homoeopathic Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoeopathic Medical College Hospital and Research Center |
| Address |
Saipura Sanganer Jaipur pin code 302029 |
| Type of Sponsor |
Private 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 Komal Yadav |
Dr Girendra Pal Homoeopathic Hospital and Research Centre |
Department of Materia Medica, Room No. 4, Unit 1 Dr. MPK Homoeopathic Medical College, Hospital and Research Centre, Homoeopathy University, 10, 11, 12, Hahnemann Marg, Diggi Malpura Road, Saipura Sanganer Jaipur
Pin code 302029
Jaipur
RAJASTHAN |
9929725886
raokomal894@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Homoeopathy University Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N209||Urinary calculus, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epigaea Repens |
Oral administration of Epigaea Repens in either 30 or 200 potency in form of globules size 40.
Dosage and Repeatition - bd or tds for seven days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients giving consent for the study
2. Patients willing to have X-ray or USG (KUB) before and after treatment
3. Cases (symptomatic and asymptomatic) with radiological evidence (Ultrasound Whole Abdomen) of renal stone. No history of expulsion of calculi after the radiological investigations within one month period
4. Patients having any urinary symptoms due to renal stone
5. Only those cases will be selected which will be having symptom similarity with the medicine Epigaea Repens |
|
| ExclusionCriteria |
| Details |
1. Females who want to conceive, are pregnant or lactating
2. Patients diagnosed with Chronic Kidney Disease, Nephrotic Syndrome
3. Cases of Hydronephrosis above grade II
4. Known cases of any other severe systemic disorders
5. Patient pursuing other treatment and are not willing to leave it
6. Gross developmental defects or structural abnormality of kidney |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| According to the scores obtained (pre and post treatment) from the Urolithiasis Symptom Scoring (USS) method |
Pre scores will be taken at baseline of treatment and post scores will be assessed at the end of 12 weeks using
Urolithiasis Symptom Scoring (USS) method |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To verify the symptoms of Epigaea Repens in cases of Urolithiasis |
12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/06/2022 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a non- randomized, open-label, single arm, uni-centre interventional study to evaluate the effectiveness of Epigaea Repens in cases of urolithiasis. The study will evaluate the extent of improvement in clinical symptoms due to renal calculi using Urolithiasis symptoms score (USS) as an assessment scale in cases of urolithiasis with Epigaea Repens and will also ascertain the clinical proved symptoms of Epigaea Repens if any. The primary outcome measures will be according to the scores obtained (pre and post treatment) from the USS scoring method. The secondary outcome measures will be to verify the clinical symptoms of Epigaea Repens.
Null Hypothesis (H0) - Epigaea Repens is not effective in cases of urolithiasis. Alternate Hypothesis (H1) - Epigaea Repens is effective in cases of urolithiasis. |