| CTRI Number |
CTRI/2023/09/057301 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
14/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical study to evaluate the efficacy of a Unani formulation in the management of Urolithiasis |
|
Scientific Title of Study
|
A Clinical study on the management of Urolithiasis with a Unani treatment- An open label single arm study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Km Antim Varun |
| Designation |
MD scholar unani |
| Affiliation |
Ayurvedic and Unani tibbia college and hospital karol bagh new delhi-110005 |
| Address |
Department of Moalijat, Ayurvedic and Unani tibbia college and hospital,ajmal khan road, karol bagh new delhi-05
Central
DELHI
110005
India |
| Phone |
9718381517 |
| Fax |
|
| Email |
varun.antim@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naseem Akhtar Khan |
| Designation |
Professor and Guide |
| Affiliation |
Ayurvedic and Unani tibbia college and hospital karol bagh new delhi-110005 |
| Address |
Department of Moalijat,Ayurvedic and Unani tibbia college and hospital ,ajmal khan road,karol bagh new delhi-110005
Central
DELHI
110005
India |
| Phone |
98100815997 |
| Fax |
|
| Email |
drkhannaseem.akhtarkhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naseem Akhtar Khan |
| Designation |
Professor and Guide |
| Affiliation |
Ayurvedic and Unani tibbia college and hospital karol bagh new delhi-110005 |
| Address |
Department of Moalijat,Ayurvedic and Unani tibbia college and hospital ,ajmal khan road,karol bagh new delhi-110005
Central
DELHI
110005
India |
| Phone |
98100815997 |
| Fax |
|
| Email |
drkhannaseem.akhtarkhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani tibbia college and hospital karol bagh new delhi-110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani tibbia college and and hospital karol bagh new delhi-110005 |
| Address |
Department of moalijat,Ayurvedic and Unani tibbia college and hospital karol bagh new delhi-110005 |
| 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 |
| Km Antim varun |
Ayurvedic and Unani tibbia college and hospital |
Department of moalijat, OPD No. 4
Central
DELHI |
9718381517
varun.antim@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurvedic and Unani tibbia college and hospital karol bagh new delhi-110005 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, (2) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Minerlo-herbal unani formulation and Pharmacopeial syrup, Hajrulyahood(lapis judaicus),Aulthi(Dolichos biflorus),Khar-Khask(Tribulus terrestris),Bhuiamla(Phyllanthus niruri),Namak turb(Raphanus sativus),Namak (Kharpazah(Cucumis melo),Namak Chirchita(Achyranthus aspera),Jawakhar(Hordeum vulgare),Aloobaloo(Prunus cerasus) |
2 Capsules (500mg each) along with Sharbat Aloo Baloo(20ml)twice a day orally for 6 weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient between the age of 18-65 years of either sex,Diagnosed cases of Urolithiasis with less than or equal to 10mm size, Patient willing to participate and sign the consent form,Patient willing to discontinue the drugs taking for the treatment of Urolithiasis |
|
| ExclusionCriteria |
| Details |
Stone size more than 10mm,Stone in the lower pole of kidney and urethra,Patients any anatomical abnormality of urinary tract,Patients with obstruction in urinary passage,Patients with gross hydronephrosis,Patients with pyelonephritis,Patients with diabetes mellitus,Pregnant and lactating women,Renal and hepatic insufficiency and malignancy,Patients unwilling to sign the consent form |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect of a mineralo- herbal Unani formulation in reducing the size of renal stone size will be assessed on USG. |
Baseline, 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Flank pain, dysuria, frequency & nausea/vomiting will be assessed. |
Baseline, 10th day, 20th day, 30th day & 42nd day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is an open label single arm study to evaluate the effects of Mineralo-herbal unani formulation and a pharmacopeial syrup in the managenmnt of urolithiasis ,diagnose case of urolithiasis,who fulfil the inclusion/exclusion criteria ,will be enrolled in the trial after making them understand about the study and taking their informed written consent . Patients will be given the treatment under study ,2 capsules (500mg each) along with Sharbat Aloo Baloo(20 ml) twice a day orally .The patients will be followed up on 10th ,20th ,30th ,and 42nd day and will be clinically evaluated on assessment parameters . The data will be statistically analysed by using appropriate statistical tests . The safety of the treatment under study will be ensured by monitoring the Haematological and biochemical indicators for kidney and liver function . Any adverse effects of the treatment during study will be noticed and recorded carefully. |