| CTRI Number |
CTRI/2024/09/073441 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic management of lower urinary tract infection |
|
Scientific Title of Study
|
Effectiveness of individualised homoeopathic medicine by using LM potency in treatment of lower urinary tract infection- a single arm prospective study |
| 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 Domina Antony |
| Designation |
PG Scholar, Department of Practice of Medicine |
| Affiliation |
National homoeopathy research institute in mental health, Kottayam, Kerala |
| Address |
National homoeopathy research institute in mental health, Sachivothamapuram p o, Kurichy, Kottayam
Kottayam
KERALA
686532
India |
| Phone |
7012907498 |
| Fax |
|
| Email |
dominaantony96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Sitharthan |
| Designation |
Principal, Professor, Head of the department, Department of practice of medicine |
| Affiliation |
National homoeopathy research institute in mental health, Kottayam, Kerala |
| Address |
Department of practice of medicine, National homoeopathy research institute in mental health, Sachivothamapuram p o, Kurichy, Kottayam
Kottayam
KERALA
686532
India |
| Phone |
9443203174 |
| Fax |
|
| Email |
sitharthan.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Sitharthan |
| Designation |
Principal, Professor, Head of the department, Department of practice of medicine |
| Affiliation |
National homoeopathy research institute in mental health, Kottayam, Kerala |
| Address |
Department of practice of medicine, National homoeopathy research institute in mental health, Sachivothamapuram p o, Kurichy, Kottayam
KERALA
686532
India |
| Phone |
9443203174 |
| Fax |
|
| Email |
sitharthan.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| National homoeopathy research institute in mental health |
|
|
Primary Sponsor
|
| Name |
Dr Domina Antony |
| Address |
Department of practice of medicine, National homoeopathy research institute in mental health, Sachivothamapuram p o, Kottayam,686532 |
| 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 Domina Antony |
National homoeopathy research institute in mental health, Kottayam, Kerala |
Department of practice of medicine, National homoeopathy research institute in mental health, Sachivothamapuram p o, Kurichy, Kottayam, Kerala,India,686532
Kottayam
KERALA |
7012907498
dominaantony96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, National Homoeoopathy Research Institute in Mental Health, Kottayam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicines in LM potency |
Appropriate Individualized
Homoeopathic Medicine will be
started from the 0/1 or the least available LM potency; followed by the next higher potency, serially, as per need of the case. The pharmacist on instruction from the investigator will dispense the medicine/placebo as follows: One globule (poppy seed size) of the desired potency will be dissolved in 120 ml of distilled water,followed by 10 uniformly forceful downward strokes will be given against the bottom of the phial. The medicine would be repeated as per the instructions given in the literature. Each participant will be advised to give 10 uniformly forceful downward strokes to the bottle with the hand and to take ONE teaspoonful of this solution and mix it in (45 ml) of water in a clean glass after stirring the solution for each dose of medicine would be takenorally. One teaspoonful (5 ml) of this solution will constitute one dose.If no change at all the case shall be retaken and another appropriate Individualized Homoeopathic remedy will be prescribed. The medicine will be given every month and total intervention period will be 6 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 18-60 years.
2.All genders.
3. Patients of lower UTI, with urine culture for positive colonies
|
|
| ExclusionCriteria |
| Details |
1.Patients with known urinary tract abnormalities.
2.Pregnant and lactating women.
3.Patients with known severe systemic illness, malignancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome of the study will be analysed according to changes in urine culture at base line, third month and sixth month |
At baseline, 3rd month, 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know about the common organisms involved in lower urinary tract infections by using urine culture |
At sixth month |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
15/09/2024 |
| 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
|
Cases will be selected from outpatient department, inpatient department and peripheral centres and
camps of NHRIMH, Kottayam. Patients presenting with symptoms of lower urinary tract
infections will be initially screened by using verbal screening form (Annexure I). Patients who
satisfy the inclusion and exclusion criteria will be explained in detail regarding the nature of the
study (Annexure II A & II B). Written informed consent will be obtained from patient and will be
enrolled in this study. Urine culture will be done at baseline, after 3 months and at the end of the
study. Case taking will be done by a standard case sheet proforma prepared for this study followed
by analysis and evaluation of the symptoms. Framing of totality and repertorisation will be done
by using synthesis repertory RADAR OPUS SOFTWARE. After final consultation with Materia
medica, individualised homoeopathic medicine will be selected. LM potency will be used. 120 ml
bottle is taken and filled with 90 ml distilled water. One medicated globule of the desired potency
is crushed with sugar of milk and added to the bottle. To this solution, 10 drops of dispensing
alcohol is added for preservation purposes. The patient will be advised to give 10 uniform
successions every time they take the medicine. From this solution, one tablespoon is added to 45
ml of water in a clean cup and stirred well. One dose (5 ml) of the solution is taken and the
rest is thrown away. The patient will be educated regarding the procedure for taking the medicine.
The medicine will be continued, stopped or changed depending upon the improvement of the patient and in accordance with homoeopathic principles. In case of any acute complaints, acute
totality will be considered and the appropriate remedy will be administered. Follow up will be
done two weeks after first visit and then onwards at 1 month interval, for a period of minimum 6
months. If there is any adverse reaction after administration of the remedy, it will be reported to
the pharmacovigilance department of the institution. |