| CTRI Number |
CTRI/2022/07/043715 [Registered on: 05/07/2022] Trial Registered Prospectively |
| Last Modified On: |
02/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A comparitive study of individualised homoeopathic medicines and organopathic mother tinctures in renal calculi |
|
Scientific Title of Study
|
A comparitive study to assess the effectiveness of Individualised homoeopathic medicines with aid of boger Boenninghausen’s Characteristics and Repertory vis-a-vis organopathic mother tinctures with aid of boericke repertory 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 Akanksha Sahu |
| Designation |
PG student |
| Affiliation |
Dr. MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Repertory Room no 3 unit 1 Dr MPK Homoeopathic Medical College Hospital and Research Centre, a constituent college of Homoeopathy University Saipura, Sanganer, Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
8377852765 |
| Fax |
|
| Email |
akankshasahu.zz28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Bidwalkar |
| Designation |
Head of Department |
| Affiliation |
Dr. MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Repertory Dr MPK Homoeopathic Medical College Hospital and Research Centre, a constituent college of Homoeopathy University Saipura, Sanganer, Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9414078227 |
| Fax |
|
| Email |
bidwalkars@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Sahu |
| Designation |
PG student |
| Affiliation |
Dr. MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Repertory Room no 3 unit 1 Dr MPK Homoeopathic Medical College Hospital and Research Centre, a constituent college of Homoeopathy University Saipura, Sanganer, Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
8377852765 |
| Fax |
|
| Email |
akankshasahu.zz28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Girendra Pal Homoeopathic Hospital & Research Centre |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoeopathic College Hospital and Research Centre |
| Address |
Plot no 10,11,12 Hahnemann Marg, Diggi Malpura Road, Saipura, Sanganer Jaipur 302029 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akanksha Sahu |
Dr Girendra Pal Homoeopathic Hospital & Research Centre |
Department of Repertory Room no. 3, Unit 1 Dr. MPK Homoeopathic Medical College , Hospital and Research Centre, Homoeopathy University Plot no 10,11,12 Hahnemann Marg, Diggi Malpura Road, Saipura, Sanganer, Jaipur 302029
Jaipur
RAJASTHAN |
8377852765
akankshasahu.zz28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Homoeopathy University Jaipur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
individualised homoeopathic medicines |
oral administration of medicines selected after repertorization by BBCR in 30, 200 or 1M potency in form of globules size 40.
Single dosage will be given in first prescription and repetition will not be done until patient is improving. Repetition will be done when same set of symptoms reappear or there is no improvement. |
| Comparator Agent |
organopathic mother tinctures |
oral administration of mother tincture selected after repertorization by boericke repertory in tincture form in half cup of luke warm water 10,15, 20 drops for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed cases with radiological evidence ( X-ray kidney/ureter/bladder and/or Ultrasound whole abdomen of calculi )
2.Undiagnosed cases with symptoms of renal colic or history of renal colic with urinary complaints.
3.Asymptomatic cases with radiological evidence (X-ray KUB/USG).
4.Patients giving consent to participate in the study.
5.No history of expulsion of calculi after radiological investigations within one month period.
|
|
| ExclusionCriteria |
| Details |
1.Cases with severe uremia, hydronephrosis, recurrent urinary tract infections or acute retention of urine for more than 24 hours.
2.Gross developmental defects or structural abnormality of kidney.
3.Pregnant women and Lactating mothers.
4.Cases with other severe systemic illness like hypertension, hypothyroidism, hyperparathyroidism, diabetes mellitus, etc.
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the effect of Individualised Homoeopathic Medicines selected with BBCR and of Organopathic Mother Tinctures selected with Boericke Repertory using VAS scale pre and post treatment scores for dysuria.
2.To assess the effect of Individualised Homoeopathic Medicines selected with BBCR and of Organopathic Mother Tinctures selected with Boericke Repertory using pre and post X- ray KUB/USG evidences for number of stones. |
1.Pre scores will be taken at baseline of treatment and post scores will be assessed at the end of 2 weeks.
2.Pre X-ray KUB/USG evidences first will be taken at the baseline of treatment and after evidences at the end of 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the more effective method of treatment mentioned above in the study |
12 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/07/2022 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This study is non - randomised, open - label, prospective, interventional, comparitive clinical trial to assess the effectiveness of individualised homoeopathic medicines selected with BBCR vis-a-vis organopathic mother tinctures selected with boericke repertory in cases of urolithiasis. The study will evaluate the extent of improvement in dysuria using VAS as an assessment scale and number of stones using x-ray KUB/USG evidences in cases of renal calculi using individualised homoeopathic medicines or organopathic mother tinctures and will also find the more effective method of treatment mentioned above. |