| CTRI Number |
CTRI/2024/10/075079 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the Effects of Two Unani Medicines, tablet Banadiq al buzoor ,Sharbat Aalu Balu with Allopathic Medicine Cap. Nitrofurantoin for Treating Simple Urinary Tract Infections (UTIs) |
|
Scientific Title of Study
|
An Open Label Randomized Standard Controlled Clinical Study to Assess the Synergistic Efficacy of Two Unani Formulations in the Management of Uncomplicated Urinary Tract Infection (Tadiya-e-Aalat-e-Baul) |
| 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 Mohd Irshad Ahmad |
| Designation |
PG Scholar |
| Affiliation |
Govt. Tibbi College and Hospital Patna |
| Address |
Dept. of Moalajat Govt. Tibbi College and Hospital Kadamkuan Patna
Patna
BIHAR
800003
India |
| Phone |
8804176430 |
| Fax |
|
| Email |
drirshadgtch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Shahnawaz Akhtar |
| Designation |
Professor |
| Affiliation |
Government Tibbi College and Hospital Address |
| Address |
Government Tibbi College and Hospital
Address
Government Tibbi College and Hospital,Arya Road,
Kadamkuan,Patna
Patna
BIHAR
800003
India |
| Phone |
9411209323 |
| Fax |
|
| Email |
amudrshahnawaz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Najibur Rahman |
| Designation |
Assistant Professor |
| Affiliation |
Government Tibbi College and Hospital |
| Address |
Government Tibbi College and Hospital,Arya Road,
Kadam kuan,Patna
Patna
BIHAR
Patna
BIHAR
800003
India |
| Phone |
7004484257 |
| Fax |
|
| Email |
dr.md.najibur.rahman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Tibbi College and Hospital Kadamkuan Patna Bihar 800003 India |
|
|
Primary Sponsor
|
| Name |
Govt Tibbi College and Hospital Kadamkuan Patna |
| Address |
Kadamkuan budhmorti Patna Bihar 800003 India |
| 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 Md Najibur Rahman |
Govt. Tibbi College and Hospital Kadamkuan Patna |
IPD and OPD ROOM NUMBER 26 DEPARTMENT OF Moalajat GTCH Kadamkuan Patna
Patna
BIHAR |
7004484257
dr.md.najibur.rahman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GTCH 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, (2) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cap. Nitrofurantoin URIFAST100mg |
Group B The standard drug, Cap. Nitrofurantoin URIFAST100mg 1 B.D orally for 14 days. |
| Intervention |
Tab. Banadiq al buzoor along with Sharbat Aalu Balu |
tablet Banadiq al buzoor 2 tab. twice a day along with Sharbat Aalu Balu 20 ml for 21 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed patient of Uncomplicated UTIs by urine culture and sensitivity .
2. Patients of either gender between the age group of 18 to 65 years.
3. Patient willing to sign the written informed consent to participate in trial.
4. Patient presenting with typical symptoms of UTIs like painful burning sensations Increased frequency of urination Urogenital urgency.
5. Patient presenting with complaint of pain in lower back or pelvic area blood in urine cloudy and bad oduor urine
6. Patients not taking any other drugs for Uncomplicated UTIs.
7. Patients who are willing and able to understand and follow the protocol for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women.
2. Patients with urinary tract stricture or any anatomical abnormality.
3. Patient with Diabetes Mellitus.
4. Patient with Hepatic & Renal insufficiency and malignancy.
5. Patient on Immunosuppressants.
6. Patient with STDs or HIV 1 and 2
7. Patient resistant to the standard control drug. nitrofurantoin
8. Patient who fails to give consent.
9. Mentally retarded person.
10. Non ambulatory and Bed ridden patients.
11. Patient willing to discontinue the drugs taking for the treatment of uncomplicated UTIs. 12. Patients with uncontrolled hypertension.
13. Patients with cardiovascular complications.
14. Patients not willing to report for follow up. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Total signs and symptoms score mentioned in synopsis
And improvement in presenting complaints |
At baseline,2nd and 3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ivestigations Globl score |
at the end of 3rd week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/10/2024 |
| 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="0"
Months="0"
Days="21" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Sixty patients diagnosed with uncomplicated UTI will be randomly allocated into two groups of 30 using block randomization. The test group will receive Banadiq al Buzoor tablets and Sharbat Aalu Balu twice daily for 21 days, while the control group will receive Nitrofurantoin capsules twice daily for 14 days. Patients will be monitored every 7 days, with safety and efficacy assessed through hemogram, E.S.R., and biochemical indicators for kidney and liver function. Voluntary informed consent will be obtained from all participants. Statistical analysis will be conducted to evaluate the data. |