| CTRI Number |
CTRI/2021/02/031069 [Registered on: 08/02/2021] Trial Registered Prospectively |
| Last Modified On: |
05/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Study on the effects of homeopathic drug Folliculinum on E coli bacteria of urinary tract infected patients in laboratory and clinical verification of same. |
|
Scientific Title of Study
|
In vitro study of homeopathic drug-Folliculinum in different potencies on cultured Escherichia coli and its clinical verification in patients with urinary tract infection.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AFIYA ALLOOR |
| Designation |
MD SCHOLAR |
| Affiliation |
GOVT HOMEOPATHIC MEDICAL COLLEGE KOZHIKODE |
| Address |
MD SCHOLAR
DEPT OF CASE TAKING AND REPERTORISATION
GOVT HOMEOPATHIC MEDICAL COLLEGE KOZHIKIDE
KARAPARAMBA
MD SCHOLAR
DEPT OF CASE TAKING AND REPERTORISATION
GOVT HOMEOPATHIC MEDICAL COLLEGE KOZHIKIDE
KARAPARAMBA
Malappuram
KERALA
673010
India |
| Phone |
9037867767 |
| Fax |
|
| Email |
afiyalloor@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRMANSOOR ALI K R |
| Designation |
PROFESSOR |
| Affiliation |
GOVT HOMEOPATHIC MEDICAL COLLEGE KOZHIKODE |
| Address |
PROFESSOR
ROOM NO 5
2ND FLOOR
DEPARTMENT OF CASE TKING AND REPERTORISATION
GOVT HOMEOPATHIC MEICAL COLLEGE C
KOXHIKODE
KARAPARAMBA
PROFESSOR
ROOM NO 5
2ND FLOOR
DEPARTMENT OF CASE TKING AND REPERTORISATION
GOVT HOMEOPATHIC MEICAL COLLEGE C
KOXHIKODE
KARAPARAMBA
Kozhikode
KERALA
673010
India |
| Phone |
9249337799 |
| Fax |
|
| Email |
similima@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
AFIYA ALLOOR |
| Designation |
MD SCHOLAR |
| Affiliation |
GOVT HOMEOPATHIC MEDICAL COLLEGE KOZHIKODE |
| Address |
PROFESSOR
ROOM NO 5
2ND FLOOR
DEPARTMENT OF CASE TKING AND REPERTORISATION
GOVT HOMEOPATHIC MEICAL COLLEGE C
KOXHIKODE
KARAPARAMBA
PROFESSOR
ROOM NO 5
2ND FLOOR
DEPARTMENT OF CASE TKING AND REPERTORISATION
GOVT HOMEOPATHIC MEICAL COLLEGE C
KOXHIKODE
KARAPARAMBA
Malappuram
KERALA
673010
India |
| Phone |
9037867767 |
| Fax |
|
| Email |
afiyalloor@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVT HOMEOPATHIC MEDICAL COLLEGE KOZHIKODE |
|
|
Primary Sponsor
|
| Name |
AFIYA ALLOOR |
| Address |
MD SCHOLAR
DEPT OF CASE TAKING AND REPERTORISATION
GOVT HOMEOPATHIC MEDICAL COLLEGE KOZHIKODE |
| Type of Sponsor |
Government 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 |
| AFIYA ALLOOR |
GOVT HOMEOPATHIC MEDICAL COLLEGE KOZHIKODE |
GOVT HOMEOPATHIC MEDICAL COLLEGE .
ROOM NO 7
2ND FLOORKOZHIKODE
KARAPARAMBA
PIN 673010
Kozhikode
KERALA |
9037867767
afiyalloor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N300||Acute cystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FOLLICULINUM 12C,30,200,1M 1M POTENCY |
SMEDICINE GIVEN IN SINGLE DOSE POTENCY ORALLY AT AN INTERVEL OF 2 WEEK ACCORDING TO PATIENTS NEED. |
| Comparator Agent |
INDIDUALISED HOMEOPATHIC MEDICINE 12C,30,200,1M,1OM |
MEDICINE GIVEN IN SINGLE DOSE ORALLY AT NEEDED POTENCY AFTER DETAILED CASE TAING BY PERFORMA. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
positive findings in urine microscopy and culture
Children aged below 10 and Female aged between 20 - 50 years.
patients willing to give written consent to participate in the trial.
|
|
| ExclusionCriteria |
| Details |
1. Infected material of patients suffering a sexually transmitted disease like HIV, syphilis, gonorrhea, Kaposi sarcoma etc.
Cases with a severe systemic illness like meningitis and septicemia.
Patients having malignancy from any origin.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing the bacterial colony count in urine culture |
2 MONTHS INTERVEL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Inhibition of bacterial growth |
2 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/02/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
 AIM-To explore the
antimicrobial effect of Homoeopathic drugs Folliculinum in various potencies
against the Escherichia
coli and clinical verification in patience with urinary tract infection. Objective
·
To determine
the in vitro effectiveness of Homoeopathic drug Folliculium in various
potencies against inhibiting the human pathogen E .coli.
·
To find out the individual effectiveness of specific
homeopathic folliculinum and Homoeopathic constitutional medicines in changing
the bacterial count in patients with
urinary tract infection.
·
To compare
the effectiveness of homoeopathic specific medicine Folliculinum relative to
constitutional medicines in changing the bacterial count in patients with
urinary tract infection.
|