| CTRI Number |
CTRI/2026/01/100985 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study in adults, to know the effectiveness of Unani formulation in repeated Urine infection. |
|
Scientific Title of Study
|
A Randomized Controlled Single Blind Comparative Clinical Trial For Evaluating The Safety And Efficacy Of
MAJOON-E-KUNDUR Versus NITROFURANTOIN In The Management Of TAADIYA-E-MAJRA-E-BAUL(Recurrent Urinary Tract Infection). |
| 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 Nadera Tarannum |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi College and Hospital |
| Address |
Department of Moalajat,
Op room no.107, green building, Government Nizamia Tibbi College and General Hospital, Charminar, Hyderabad, Telangana-500002, India.
Hyderabad
TELANGANA
500002
India |
| Phone |
8309954255 |
| Fax |
|
| Email |
princesstarakhan19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Narasimha |
| Designation |
Professor |
| Affiliation |
Government Nizamia Tibbi College and Hospital |
| Address |
Department of Moalajat,
Op room no.107, green building, Government Nizamia Tibbi College and General Hospital, Charminar, Hyderabad, Telangana-500002, India.
Hyderabad
TELANGANA
500002
India |
| Phone |
9866985269 |
| Fax |
|
| Email |
dr.n.narasimha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nadera Tarannum |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi College and Hospital |
| Address |
Department of Moalajat,
Op room no.107, green building, Government Nizamia Tibbi College and General Hospital, Charminar, Hyderabad, Telangana-500002, India.
Hyderabad
TELANGANA
500002
India |
| Phone |
8309954255 |
| Fax |
|
| Email |
princesstarakhan19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Moalajat, Op room no 107, green building, Government Nizamia Tibbi College and General Hospital, Charminar, Hyderabad, Telangana - 500002 India |
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi College and Hospital |
| Address |
Government Nizamia Tibbi College and Hospital Moghalpura, Charminar, Hyderabad, Telangana-500002 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 Nadera Tarannum |
Government Nizamia Tibbi College and Hospital |
Department of Moalajat,
Op room no 107, green building, Charminar, Hyderabad, Telangana-500002, India.
Hyderabad
TELANGANA |
8309954255
princesstarakhan19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GNTC HYDERABAD |
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 |
Majoon-e-Kundur |
MAJOON-E-KUNDUR | 5gram | Oral | BID | with Water | After Meals | ×10days.
Ingredients:
1.Juft Baloot
(Quercus incana, Roxb)
2.Zanjabeel
(Zingeber officinale Roxb)
3.Saad kufi / Nagar Motha
(Cyperus scariousus)
4.Filfil Siyah
(Piper nigrum Linn)
5. Qust Sheerin
(Saussurea lappa)
6.Kundur
(Boswellia serrata)
7.Qand-Shakkar
(Saccharum officinarum) |
| Comparator Agent |
Nitrofurantoin |
TAB. NITROFURANTOIN | 100mg | Oral | 1Tablet | BID | With Water | After Meals | ×10days.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group from 18 to 50 years.
2.Either Gender.
3.Patients with Symptoms of
Dysuria,
Burning micturition with or without fever.
Frequency of micturition & Urgency.
4.Patient with recurrent UTI.
5.Patient with positive Urine Dipstick & Urine Culture. |
|
| ExclusionCriteria |
| Details |
1.Pregnant & Lactating Women, Children.
2.Patients with Diabetic mellitus.
3.Patients with Uncontrolled Hypertensive.
4.Patient with Complicated UTI.
5.Patient with Congenital abnormalities.
6.Patient with Significant Pulmonary/Cardiovascular/ Hepato-renal Dysfunction/ Psychiatric illness Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies.
7.Participant who had received any treatment within month of start of study.
Patient not willing to attend treatment schedule regularly. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Sign and Symptoms |
7th day & 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in CUE,Urine Dipstick (Nitrates), Urine Culture, CBP, CRP, LFT, Sr.Creatinine. |
14th day |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/03/2026 |
| 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="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
|
Recurrent UTI’S are common and defined as more then two symptomatic episode occuring over 6 months or more than three symptomatic episodes over 12 months. Urinary tract infection (UTI) is associated with multiplication of organisms in the Urinary tract, and is defined by the presence of more than 100000 organisms per ml in a mid stream Urine (MSU) of sample. UTI remains the most common infection worldwide, which can occur in any time of an individual lifes. Population studies from numerous countries have reported the prevalence of 13% in Hyderabad, with a female predominance. Despite widespread use of antibiotics, it leads to resistance and side effects, necessitates exploring alternative therapies to find natural treatments that are effective, safe, and reduce dependency on antibiotics. Unani formulations like Majoon-e-kundur known for it’s anti-inflammatory & anti-microbial properties former purifies blood and corrects infection, may offer a, safer alternative. This study aims for scientific validation through RCT essential to establish it’s therapeutic potential. |