| CTRI Number |
CTRI/2021/06/034066 [Registered on: 08/06/2021] Trial Registered Prospectively |
| Last Modified On: |
05/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study for the management of infection in urine caused by bacteria E. coli with the help of herbal drugs. |
|
Scientific Title of Study
|
A Clinical Study on the Management of Urinary Tract Infection (Tadiya-e-Majra-e-Baul) caused by E. coli with a Unani Polyherbal Formulation, An Open Single Arm Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAIS UR RAHMAN |
| Designation |
HEAD, DEPARTMENT OF MOALIJAT |
| Affiliation |
AYURVEDIC and UNANI TIBBIA COLLEGE and HOSPITAL |
| Address |
AYURVEDIC and UNANI TIBBIA COLLEGE and HOSPITAL, KAROL BAGH, NEW DELHI
Central
DELHI
110005
India |
| Phone |
9313980776 |
| Fax |
|
| Email |
drrahman002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAIS UR RAHMAN |
| Designation |
HEAD, DEPARTMENT OF MOALIJAT |
| Affiliation |
AYURVEDIC and UNANI TIBBIA COLLEGE and HOSPITAL |
| Address |
AYURVEDIC and UNANI TIBBIA COLLEGE and HOSPITAL, KAROL BAGH, NEW DELHI
Central
DELHI
110005
India |
| Phone |
9313980776 |
| Fax |
|
| Email |
drrahman002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAIS UR RAHMAN |
| Designation |
HEAD, DEPARTMENT OF MOALIJAT |
| Affiliation |
AYURVEDIC and UNANI TIBBIA COLLEGE and HOSPITAL |
| Address |
AYURVEDIC and UNANI TIBBIA COLLEGE and HOSPITAL, KAROL BAGH, NEW DELHI
Central
DELHI
110005
India |
| Phone |
9313980776 |
| Fax |
|
| Email |
drrahman002@gmail.com |
|
|
Source of Monetary or Material Support
|
| AYURVEDIC and UNANI TIBBIA COLLEGE and HOSPITAL, KAROL BAGH, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
RAIS UR RAHMAN |
| Address |
AYURVEDIC and UNANI TIBBIA COLLEGE and HOSPITAL, KAROL BAGH, NEW DELHI-05 |
| Type of Sponsor |
Other [] |
|
|
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 |
| ALMAS QURESHI |
AYURVEDIC and UNANI TIBBIA COLLEGE and HOSPITAL |
OPD No. 4, DEPARTMENT OF MOALIJAT (MEDICINE), AJMAL KHAN ROAD, KAROL BAGH, NEW DELHI-05
Central
DELHI |
9953030173
almasqureshi8406@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:N309||Cystitis, unspecified. Ayurveda Condition: TADIYA-E-MAJRA-E-BAUL, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
UNANI POLYHERBAL FORMULATION |
Dose - 500mg (extract) capsule
Frequency -1 capsule thrice a day
Duration- 42 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
DIAGNOSED PATIENTS OF E. COLI INDUCED URINARY TRACT INFECTION (BY URINE CULTURE)
WILLING TO PARTICIPATE AND SIGN THE INFORMED UNDERSTOOD CONSENT FORM |
|
| ExclusionCriteria |
| Details |
PATIENTS WITH ANY ANATOMICAL ABNORMALITY OF URINARY TRACT, DIABETES MELLITUS, HEPATIC AND RENAL INSUFFICIENCY, PREGNANT AND LACTATING WOMEN, STDs AND HIV |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and efficacy of the proposed Unani Polyherbal Formulation for the management of Urinary Tract Infection caused by E. coli. |
Clinical examination and subjective evaluation would be done at baseline, 7 day, 15 day, 30 day and 42 day. Safety evaluation will be performed and recorded at baseline, 7 day and 42 day.
CBC, LFT & KFT would be done. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To develop a safe, efficacious and cost-effective drug from a herbal source for the management of Urinary Tract Infection caused by E. coli |
For safety evaluation CBC, LFT & KFT would be done. |
|
|
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)
|
22/06/2021 |
| 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="6"
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
|
It is a clinical study on the management of Urinary Tract Infection caused by E. coli with a Unani Polyherbal Formulation containing seven drugs namely, Tribulus terrestris, Phyllanthus niruri, Piper cubeba, Cichorium intybus, Apium Graveolens, Glycyrrhiza glabra and Tinospora cordifolia. It would be an Open Single Arm study. Duration of the study will be 1.5 years and duration of the protocol therapy will be 6 weeks. 40 patients will be included in the study. Patient will be given the test drug, prepared in capsule form of Unani Polyherbal Formulation (extract 500mg) thrice a day orally. The safety and efficacy of the test drug will be ensured by monitoring the hemogram with E.S.R. and serological indicators for kidney and liver functions. |