| CTRI Number |
CTRI/2025/07/091634 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of kushta hajarul yahood in cases of cholelithiasis: A clinical study |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of kushta Hajarul yahood in the management of Hasat e Mararah (cholelithiasis) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NAHID ANJUM |
| Designation |
PG SCHOLAR |
| Affiliation |
State Takmeel Ut Tib College And Hospital |
| Address |
Department Of Ilmul Jarahat State Takmeel ut tib college and hospital near rama bai railly sthal
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
7703992557 |
| Fax |
|
| Email |
Nahidanjum344@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakhshinda Baig |
| Designation |
Reader |
| Affiliation |
State Unani Medical College Prayagraj |
| Address |
Department Of Ilmul Jarahat State Unani Medical College Prayagraj
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
09415337189 |
| Fax |
|
| Email |
baigrakhshi12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Abdul quavi |
| Designation |
Professor And HOD |
| Affiliation |
State Takmeel Ut Tib College And Hospital |
| Address |
Department Of Ilmul Jarahat State Takmeel Ut Tib College And Hospital Near Ramabai Ambedkar Raili Sthal Rd Babasaheb Bhim Rao Ambedkar University Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
09455077880 |
| Fax |
|
| Email |
quavinium@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Takmeel ut Tib College And Hospital Near Rama Bai Railly Sthal Aurangabad Khalsa Lucknow Pincode 226025 UP INDIA |
|
|
Primary Sponsor
|
| Name |
STATE TAKMEEL UT TIB COLLEGE AND HOSPITAL |
| Address |
NEAR RAMA BAI RAILLY STHAL AURANGABAD KHALSA 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 NAHID ANJUM |
State Takmeel ut Tib College And Hospital Lucknow |
Department Of Ilmul Jarahat State Takmeel ut tib college and hospital near rama bai railly sthal
Lucknow
UTTAR PRADESH |
07703992557
Nahidanjum344@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee State Takmeel ut Tib College And Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KUSHTA HAJARUL YAHOOD |
500 MG TO 1 GRAM TWICE A DAY AFTER MEALS ORALLY FOR 49 DAYS |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Cholelithiasis patients having symptoms and confirmed by USG Whole Abdomen
Patients of both the sexes in between the age group of 20 to 60 years
Patients with functioning gall bladder
Consent of patient |
|
| ExclusionCriteria |
| Details |
Choledocolithiasis
Ca Gallbladder
Contracted gallbladder
Shrinked gallbladder
Thickened gallbladder
Fibrosed gallbladder
Mucocoele of gallbladder
Pyocoele of gallbladder
Obstructive Jaundice
Stone size less than 15 mm
Multiple stones
Diabetes Mellitus
Pregnancy and Lactation
Mentally Retarded Patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Discomfort in right hypochondrium
Pain in right hypochondrium
Nausea and vomiting
Flatulent and dyspepsia
Tenderness (Right upper quadrant)
Referred pain to tip of right shoulder |
0, 7th, 14th, 21st, 28th, 35th and 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| USG Whole Abdomen |
0 and 42nd 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)
|
04/08/2025 |
| 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
|
Dr. Nahid Anjum, a postgraduate scholar at the State Takmeel-ut-Tib College and Hospital, Lucknow, proposes a clinical study to evaluate the efficacy of a Unani formulation, Kushta Hajarul Yahood, in treating Hasat-e-Mararah (cholelithiasis or gallstones). The research is grounded in both Unani and modern medical understandings of gallstone pathology, aiming to provide an effective, economical, and non-surgical alternative to cholecystectomy. The study will involve 30 patients over 42 days in an open-label, single-arm clinical trial, with data collected through clinical symptoms and ultrasound imaging. Kushta Hajarul Yahood, a compound of Hajarul Yahood (Lapis Judaicus), Shorah Qalmi (Potassium Nitrate), and Aab-e-Mooli (Radish juice), is known in Unani literature for its lithotriptic, anti-inflammatory, and diuretic properties. Patients will be assessed based on symptomatic improvement and changes in stone size, while safety will be monitored through standard laboratory tests. The research seeks to validate traditional Unani treatments and offer relief to patients unwilling or unfit for surgery. |