| CTRI Number |
CTRI/2025/12/099670 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [Qurs] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare Banadiqul Bazoor with Nitrofurantoin for Treating Acute Cystitis (Warm-e-Masana Had) |
|
Scientific Title of Study
|
An Open-Labelled Randomised Controlled Clinical Trial to Evaluate the Safety & Efficacy of Banadiqul Bazoor in Cases of Warm-e-Masana (Had Acute Cystitis) with Nitrofurantoin |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maankala Sreekanth |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
OPD Room No. 107, PG Department of Moalajat, General Medicine, Government Nizamia Tibbi College and General Hospital, Charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
9347016271 |
| Fax |
|
| Email |
Srikanthmankala773@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N Narasimha |
| Designation |
Professor |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
OPD Room No. 107, PG Department of Moalajat, General Medicine, Government Nizamia Tibbi College and General Hospital, Charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
9866985269 |
| Fax |
|
| Email |
dr.n.narasimha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
N Narasimha |
| Designation |
Professor |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
OPD Room No. 107, PG Department of Moalajat, General Medicine, Government Nizamia Tibbi College and General Hospital, Charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
9866985269 |
| Fax |
|
| Email |
dr.n.narasimha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College And General Hospital, Charminar, Hyderabad, Telangana-500002 |
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi College and General Hospital |
| Address |
Government Nizamia Tibbi College and General Hospital, Charminar, Hyderabad, Telangana, 500002 |
| 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 |
| Maankala Sreekanth |
Govt. Nizamia Tibbi College and General Hospital |
OPD Room No. 107, PG Department of Moalajat, General Medicine
Govt. Nizamia Tibbi College and General Hospital, Charminar
Hyderabad
TELANGANA |
9347016271
Srikanthmankala773@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Nizamia Tibbi College, Hyderabad |
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 |
Banadiqul Bazoor |
Therapy Duration: 30 days
Sample Size: 25 participants
Treatment Plan:
Group A: Banadiqul Bazoor — 2 tablets BD (twice daily) after meals for 30 days, with follow-ups at 10-day intervals. |
| Comparator Agent |
Tablet Nitrofurantoin 100 mg |
Therapy Duration: 30 days
Sample Size: 25 participants
Treatment Plan:
Group B: Tablet Nitrofurantoin 100 mg — one tablet BD (twice daily) after meals for 10 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age limit 18-60 years.
Sex-Both sexes.
Patients with burning micturition.
Patients with dysuria.
Patients with urgency of urine.
Patients with frequency of micturition. |
|
| ExclusionCriteria |
| Details |
Patients with pregnancy and lactation.
Patients with renal calculi & vesicle calculi .
Patients with uncontrolled hypertensive .
Patients with uncontrolled diabetic .
Patients with systemic illness like cardiac failure, renal failure, hepatic failure etc. |
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and efficacy of banadiqul bazoor in cases of warm e masana |
Once in two weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety and efficacy of Nitrofurantoin in cases of warm e masana |
Once in two weeks |
|
|
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)
|
05/01/2026 |
| 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="2"
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
|
Cystitis Inflammation of the urinary bladder associated with Dysuria increased frequency of urine and Suprapubic painUrinary tract infection more frequently in women than men it is estimated that more than 30percent of women will experience at least one episode of cystitis in their life timeMore than 7 million uncomplicated UTIs occur in US According to Buqrat indisease was caused by alteration in kamiyat quantity aur kaifiyat quality of Akhlath that is alteration in mizaj temperament of akhlath of any organ This holds good to infections as well as metabolic diseases Warm e masana haad is caused by gair tabayyi safravi and damvi madda This abnormal madda leads to hiddath and hiddath leads to infection Warm e masana haad is caused by gair tabayyi safravi and damvi madda This abnormal madda leads to hiddath and hiddath leads to infection |