| CTRI Number |
CTRI/2023/08/056290 [Registered on: 08/08/2023] Trial Registered Prospectively |
| Last Modified On: |
04/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Usefulness of Homoeopathy in the Treatment of urinary tract stones. |
|
Scientific Title of Study
|
Effectiveness of Individualised Homoeopathic medicines
in comparison with Berberis Vulgaris
in the treatment of Urolithiasis:
An open label prospective randomised clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Christina Lalhriatpuii |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy,Kolkata |
| Address |
Department of Materia medica.National Institute of Homoeopathy, Block-GE, Sector-III, Salt lake, Kolkata.
Kolkata
WEST BENGAL
700106
India |
| Phone |
9163234860 |
| Fax |
|
| Email |
christieswiftie@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanta Rath |
| Designation |
Professor & HOD, Community Medicine,National Institute of Homoeopathy,Kolkata |
| Affiliation |
National Institute of Homoeopathy,Kolkata |
| Address |
National Institute of Homoeopathy, Block-GE, Sector-III, Salt lake, Kolkata.
Kolkata
WEST BENGAL
700106
India |
| Phone |
8420924836 |
| Fax |
|
| Email |
drprasantarath09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Christina Lalhriatpuii |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute of Homoeopathy,Kolkata |
| Address |
Department of Materia medica.National Institute of Homoeopathy, Block-GE, Sector-III, Salt lake, Kolkata.
Kolkata
WEST BENGAL
700106
India |
| Phone |
9163234860 |
| Fax |
|
| Email |
christieswiftie@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Kolkata
Address-National Institute of Homoeopathy, Block-GE, Sector-III, Salt lake, Kolkata.
|
|
|
Primary Sponsor
|
| Name |
none |
| Address |
none |
| Type of Sponsor |
Other [none] |
|
|
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 CHRISTINA LALHRIATPUII |
National Institute of Homoeopathy,Kolkata |
Room no 18-Materia Medica Department/In-patient department of NIH.
Address: Block-GE, Sector-III, Saltlake, Kolkata
Kolkata
WEST BENGAL |
9163234860
christieswiftie@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N20-N23||Urolithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Berberis vulgaris |
Berberis vulgaris will be administered in fifty millesimal potencies. Dosage- 30 doses, ODAC for 1month.Route-oral route. Total duration-6 months. Along with medicines, they
will receive dietary advices also |
| Intervention |
Individualised Homoeopathic Medicines |
Intervention is planned as administering individualised Homoeopathic medicines in fifty millesimal potencies.
Dosage- 30 doses, ODAC for 1month.Route-oral route. Total duration-6 months. Along with medicines, they will receive
dietary advices also. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with urolithiasis (by radiological evidence: Ultrasonography of
lower abdomen/K.U.B/C.T/M.R.I etc.)
2.Patients between 20-70 years of age, all religions, all socio-economic status.
3.All sexes, genders, races.
4.Patients who are on lifesaving conventional drug therapies (e,g antidiabetics,
antihypertensives, thyroid drugs)to be continued uninterrupted.
6.Patients who are willing to give written consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Diagnosed cases of unstable mental or psychiatric illness.
2.Patients who are suffering from any life-threatening illness or other uncontrolled
systemic disease affecting quality of life or any other vital organ.
3.Patients who are suffering from any major complication, Congenital Anomalies of
Kidney and the Urinary Tract, severe hydronephrosis.
4.Patients who are on active treatment from any other system of medicine.
5.Patients not willing to give consent for participation in the study.
6.Patients not willing to undergo any investigation if advised. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome: Urolithiasis Symptom Score (USS score)
On the basis of score obtained from USS index chart, cases according to intensity
will be grouped into mild (1-7), moderate (8-14) and severe (15-22). The scores of the initial
and follow ups will be compared. |
Baseline,3rd and 6th month of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ultrasonography of KUB region at baseline,3
rd and 6th month of treatment will be
done to assess/compare the number, size and location of the calculus/calculi.
|
Baseline,3rd and 6th month of treatment |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
21/08/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Urolithiasis is the formation of urinary calculi in the urinary system. Urolithiasis is a common, highly recurrent disease with increasing prevalence worldwide. Apart from conservative treatment, extra corporeal shock-wave lithotripsy (ESWL)and ureteroscopy are commonly practiced in conventional medicine in cases of calculi, but these interventions are expensive for the common people and may lead to complications. The possible morbidity, significant cost and the need for highly specialized equipment and special expertise raise the question whether the current treatments are indeed the most attractive options to meet the increasing demand. Hence it would be worthwhile to look for an alternative, by using homoeopathic medicines for the treatment of urolithiasis. HYPOTHESES: A. i) NULL HYPOTHESIS(H0): There is no significant difference in the Urolithiasis Symptoms Score(USS) before and after treatment of urolithiasis with Individualised Homoeopathic (IH) medicines. ➢ ii)ALTERNATIVE HYPOTHESIS (HA): There is a significant difference in the Urolithiasis Symptoms Score(USS) before and after treatment of urolithiasis with Individualised Homoeopathic(IH) medicines.
B. i) NULL HYPOTHESIS(H0): There is no significant difference in the Urolithiasis Symptoms Score(USS) before and after treatment of urolithiasis with Berberis Vulgaris(BV). ii) ALTERNATIVE HYPOTHESIS (HA): There is a significant difference in the Urolithiasis Symptoms Score(USS) before and after treatment of urolithiasis with Berberis Vulgaris(BV). C. i) NULL HYPOTHESIS(H0): There is no significant difference in changes (before and after treatment) of Urolithiasis Symptoms Score(USS) in Individualised Homoeopathic (IH)medicines in comparison with Berberis Vulgaris (BV) in the treatment of urolithiasis. ii) ALTERNATIVE HYPOTHESIS (HA): There is a significant difference in changes (before and after treatment) of Urolithiasis Symptoms Score(USS) in Individualised Homoeopathic (IH) medicines in comparison with Berberis Vulgaris (BV) in the treatment of urolithiasis. |