| CTRI Number |
CTRI/2025/07/090659 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [Therapeutic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A STUDY To Evaluate Effectiveness oF Kushta Hajrul Yahood in the management of kidney stone |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy of Kushta Hajrul Yahood in cases of Hasat-i-Kulya(Renal calculus) |
| Trial Acronym |
Renal Calculus |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RIZWANA BEGUM |
| Designation |
P G SCHOLAR |
| Affiliation |
STATE TAKMEEL UT TIB COLLEGE AND HOSPITAL NEAR RAMABAI RAILLY STHAL LUCKNOW |
| Address |
DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UT TIB COLLEGE AND HOSPITAL NEAR RAMABAI RAILLY STHAL LUCKNOW
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
8887639653 |
| Fax |
|
| Email |
drrizwana16437@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Abdul Quavi |
| Designation |
Professor and HOD |
| Affiliation |
STATE TAKMEEL UT TIB COLLEGE AND HOSPITAL NEAR RAMABAI RAILLY STHAL LUCKNOW |
| Address |
DEPARTMENT OF ILMUL JARAHAT STATE TAKMEEL UT TIB COLLEGE AND HOSPITAL NEAR RAMABAI RAILLY STHAL LUCKNOW
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
9455077880 |
| Fax |
|
| Email |
quavinium@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAKHSHINDA BAIG |
| Designation |
READER |
| Affiliation |
STATE UNANI MEDICAL COLLEGE AND HOSPITAL PRAYAGRAJ |
| Address |
DEPARTMENT OF ILMUL JARAHAT STATE UNANI MEDICAL COLLEGE AND HOSPITAL PRAYAGRAJ
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9415337189 |
| Fax |
|
| Email |
baigrakhshi12@gmail.com |
|
|
Source of Monetary or Material Support
|
| STATE TAKMEEL UT TIB COLLEGE AND HOSPITAL NEAR RAMABAI RAILLY STHAL LUCKNOW |
|
|
Primary Sponsor
|
| Name |
STATE TAKMEEL UT TIB COLLEGE AND HOSPITAL |
| Address |
NEAR RAMABAI RAILLY STHAL LUCKNOW |
| 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 RIZWANA BEGUM |
State Takmeel ut Tib College and Hospital Lucknow |
Department of Ilmul Jarahat Near Rama bai Rally Sthal
Bijnor Road 226025 Lucknow UTTAR PRADESH
Lucknow
UTTAR PRADESH |
8887639653
drrizwana16437@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee State Takmeel uttib College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kushta Hajrul Yahood include the following ingredients:Hajrul yahood 50gm, Shora Qalmi 100mg, Aab-e-turb 3 litre |
Kushta 125 mg BD orally for 6 weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of renal stone up to 10 mm Controlled case of diabetes
Patient who have agreed to sign the informed consent form and follow up the protocol |
|
| ExclusionCriteria |
| Details |
Patient below 20 and above 60 years of age
Patient diagnosed as stone more than 10 mm and location other than kidney
Any acute and chronic kidney disease
Patient having severe flank pain gross hematuria hydronephrosis hydroureteronephrosis and deranged RFT(Renal Function Test)
Uncontrolled diabetes melitus
any systemic illness
malignency
pregnency and lactating women
mentally retard person
bladder outlet obstruction
patient who fail to give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain in flank region
burning micturition
hematuria
nausea/vomiting
frequency of micturition |
0, 15th, 30th, 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
X-Ray KUB
USG Whole Abdomen |
0 and 45th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
21/07/2025 |
| 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
|
The study will be an observational prospective interventional clinical noncomparative study with a sample size of 30 patients aged 20-60 years diagnosed with renal stones up to 10 mm The duration of the protocol is 45 days The formulation Kushta Hajrul Yahood contains Hajrul Yahood 50 gm Shora Qalmi 100 gm and Aab e turb 3 liters and will be administered orally at 125 mg twice a day Patients will be evaluated based on subjective pain burning micturition hematuria nausea or vomiting frequency of micturition and objective X ray KUB USG whole abdomen parameters |