| CTRI Number |
CTRI/2025/04/085795 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effects of Polyherbal Unani Formulation with a standard drug in the Management of Uncomplicated Urinary tract infection. |
|
Scientific Title of Study
|
A Clinical study to evaluate the Efficacy of a Unani Formulation in the management of uncomplicated Urinary Tract infection (Waram-E-Aalate Bawl)-Randomized control Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HUZAIFA FATHIMA P |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and hospital |
| Address |
Department of Ilmul Qabalat wa Amraz e Niswan
Ayurvedic and Unani Tibbia College and hospital
Ajmal khan road
Karol Bagh
Central
DELHI
110005
India |
| Phone |
8682989724 |
| Fax |
|
| Email |
huzaifafathima021@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AYSHA RAZA |
| Designation |
Associate Professor and Supervisor |
| Affiliation |
Ayurvedic and Unani Tibbia college and hospital |
| Address |
Department of Ilmul Qabalat wa Amraz e Niswan
Ayurvedic and Unani Tibbia College and hospital
Ajmal khan road
Karol Bagh
Central
DELHI
110005
India |
| Phone |
9354925031 |
| Fax |
|
| Email |
draysharaza11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HUZAIFA FATHIMA P |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia college and hospital |
| Address |
Department of Ilmul Qabalat wa Amraz e Niswan
Ayurvedic and Unani Tibbia College and hospital
Ajmal khan road
Karol Bagh
Central
DELHI
110005
India |
| Phone |
8682989724 |
| Fax |
|
| Email |
huzaifafathima021@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia college and hospital
Ajmal khan road,Karol bagh, New Delhi -110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia college and hospital |
| Address |
Department of Ilmul Qabalat wa Amraz e Niswan,
Ayurvedic and Unani Tibbia college and hospital,
Ajmal khan road,
Karol Bagh, New Delhi-110005 |
| 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 |
| Dr HUZAIFA FATHIMA P |
Ayurvedic and Unani Tibbia college and hospital |
OPD No 14, Department of Ilmul Qabalat wa Amraz e Niswan, Ayurvedic and Unani Tibbia college and Hospital, Ajmal khan road, Karol Bagh, New Delhi
Central
DELHI |
8682989724
huzaifafathima021@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurvedic and Unani Tibbia college and hospital |
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 |
| Comparator Agent |
Capsule/Tab.Nitrofurantoin |
One tablet/capsule of Nitrofurantoin 50mg twice daily orally with plain water for 7days/1 week |
| Intervention |
Powder of Unani Drug-Kabab chini(Cubeba officinalis)2g,along with Sharbat e sandal |
2 capsule of 500mg twice daily orally with Sharbat e sandal 10ml for 15 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient willing to participate in the study and sign the informed consent form.
2.Female patients of the reproductive age group between 20-45 years.
3.Presenting with acute following symptoms(Burning micturition,dysuria, frequency and urgency)
4.Diagnose cases of urinalysis showing pus cells (7-10 white blood cells per high-powered field). |
|
| ExclusionCriteria |
| Details |
1.Below 20 and 45 years
2.Any signs evoking complicated UTI, pyelonephritis (fever more or equal 38 degree Celsius, back pain,chills and shivers.
3.Concomitant vulvovaginitis.
4.Conditions leading to complicated infections (Renal diseases, urinary tract abnormalities,past urinary surgery, urine catheterization etc)
5.Pregnancy and lactating mother
6.Cardiovascular diseases and any systematic illness.
7.H/o Sexually transmitted diseases
8.Immune compromised pateints |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the safety and efficacy of the proposed Unani Formulation on scientific parameters.
2.To compare the results of Unani Formulation with the standard control in the treatment of uUTI in respect of safety and efficacy.
|
Improvement in signs and symptoms of uUTI patient at 15 days from base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Unani polyherbal formulation on quality of the patient |
Change in urinalysis showing pus cells at 15 days from base line |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2 |
|
Date of First Enrollment (India)
|
07/05/2025 |
| 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
|
This study is a randomised, parallel group,active control clinical trial to evaluate the Efficacy and safety of the unani drug in the dose of two capsule (each capsule containing 500mg) with Sharbat e Sandal in the management of Uncomplicated Urinary tract infection and to compare it’s efficacy with a standard drug.The microbes responsible for UTI are similar across the world in both advanced and developing nations.These bacteria have developed unique methods of survival and resistance to persist in the urinary system.Unfortunately,UPEC continue to show increased resistance to some of the antibiotics as prescribed in Allopathic system of medicine. In addition, antibiotic use may harm patients suffering from asymptomatic bacteriuria.It was concluded to be beneficial not to treat younger women suffering from asymptomatic bacteriuria with antibiotics due to a possible protective effect of colonizing bacteria.Solely symptomatic treatment of acute uUTI also seems to be an option. Therefore,in place of antibiotics prescribed in Allopathic system of medicine and it’s arising resistance towards asymptomatic UTIs,The safety and efficacy of suitable herbal drug Kabab chini(Cubeba officinalis) have not been evaluated on scientific parameters. Hence,there is a need to develop a safe, efficacious and economical drug on modern scientific parameters from the herbal treasury of Unani medicine for the treatment of uUTI. The purpose of this study is to provide a safe and effective drug for managing uUTI and to compare it’s efficacy with a standard drug. |