| CTRI Number |
CTRI/2022/09/045671 [Registered on: 19/09/2022] Trial Registered Prospectively |
| Last Modified On: |
21/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Recurrent Urinary tract infection (rUTI) |
|
Scientific Title of Study
|
Clinical Study Of Recurrent Urinary tract infection( Tadiya Majari e Bol Mutwatir) and its management with unani medicines. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Qudsiya Aaftab |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi College and General Hospital Charminar Hyderabad |
| Address |
Government Nizamia Tibbi College and General Hospital Charminar Hyderabad
Government Nizamia Tibbi College and General Hospital Charminar Hyderabad..
Hyderabad
TELANGANA
500002
India |
| Phone |
8801008577 |
| Fax |
8801008577 |
| Email |
aaftabqudsiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MA FAROQUI |
| Designation |
HOD Department of General Medicine (Moalejat) |
| Affiliation |
Government Nizamia Tibbi College and General Hospital Charminar Hyderabad |
| Address |
Government Nizamaia Tibbi College and General Hospital Charminar Hyderabad
Government Nizamaia Tibbi College and General Hospital Charminar Hyderabad..
Hyderabad
TELANGANA
500002
India |
| Phone |
8801008577 |
| Fax |
8801008577 |
| Email |
dr.faroqui@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Qudsiya Aaftab |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi College and General Hospital Charminar Hyderabad |
| Address |
Government Nizamaia Tibbi College and General Hospital Charminar Hyderabad
Government Nizamaia Tibbi College and General Hospital Charminar Hyderabad..
Hyderabad
TELANGANA
500002
India |
| Phone |
8801008577 |
| Fax |
8801008577 |
| Email |
aaftabqudsiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG dept of Moalejat(General Medicine) |
|
|
Primary Sponsor
|
| Name |
PG Dept of Moalejat General Medicine |
| Address |
PG Dept of Moalejat (General Medicine)Govt.Nizamia Tibbi College and Hospital |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Qudsiya Aaftab |
Govt NizamiaTibbi College and General Hospital |
OP Block
Room No 122
Hyderabad
TELANGANA |
8801008577
0
aaftabqudsiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
Clinical Study of Recurrent Urinary tract infection(Tadiya Majari e Bol Mutwatir) and its management with unani medicines |
Each patient is treated with unani formulations for 6 weeks which is in the form of powder of 5gms with water in Bd dose containing Baloot (Quercus incana),Shore khalmi(Potassium nitrate),Ushba desi(Hemidesmus indicus),Chobchini( Smilax china),Gajga(Caisalpinia Bonducella) and decoction of 150 ml in Bd dose containing kulthi ( Dolichos bifloris),kharkhask(Tribulas terristris). |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Recurrent uti with positive urine culture,
2.Patients with symptoms as follows
a.Burning micturition
b.Urgency,
c.frequency of micturition d.Haematuria(Benign)
e.Lower abdominal pain/supra pubic pain
f.Fever with chills and rigor
g.Nausea and vomitings
3.Patients with renal calculi. |
|
| ExclusionCriteria |
| Details |
1.Complicated UTI
2.Patients with pregnancy
3.Patients with BPH
4.Chronic infections like TB; Gonorrhea; Syphills
5.Diabetes Mellitus
6.Patients with congenital abnormalities like polycystic kidney; renal
agenesis; renal hypoplasia ; uretrovesical junction obstruction. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Depends on before and after treatment.
Treatment will be given for the duration of 6 weeks |
Cure of the disease,relief in symptoms |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Depends on before and after treatment |
1.Changes in urine culture and sensitivity i.e negative culture 2.Cure of the disease, relief in symptoms |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/09/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In Recurrent Urinary tract infection (Rutis) usual prophylactic antibiotics regimens donot change the long term risk of occurrence.the aim of the study is to evaluate the efficacy of unani medicines in Rutis.In this Randomised Single arm study with a sample size of 40 patients and 6 weeks of treatment with some inclusion and exclusion criteria( mentioned in part 6). The study will be conducted. |