| CTRI Number |
CTRI/2024/08/072080 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of internal use of Apamarga kshara in the management of nephrolithiasis |
|
Scientific Title of Study
|
Efficacy of internal use of Apamarga kshara in the management of mutrashmari with special reference to nephrolithiasis |
| 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 Subir Kumar Khan |
| Designation |
Reader, Department of Kayachikitsa |
| Affiliation |
The West Bengal University of Health Sciences |
| Address |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital
294/3/1 A.P.C Road Kolkata
DD 36, 2nd Avenue, DD Block, Sector 1, Bidhannagar, Kolkata, West Bengal 700064
Kolkata
WEST BENGAL
700009
India |
| Phone |
8944006115 |
| Fax |
|
| Email |
subirkrkhan2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mainak Biswas |
| Designation |
Pg Scholar Department of Kayachikitsa |
| Affiliation |
The West Bengal University of Health Sciences |
| Address |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital
294/3/1 A.P.C Road Kolkata
DD 36, 2nd Avenue, DD Block, Sector 1, Bidhannagar, Kolkata, West Bengal 700064
Kolkata
WEST BENGAL
700009
India |
| Phone |
8447804708 |
| Fax |
|
| Email |
mainakb95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mainak Biswas |
| Designation |
Pg Scholar Department of Kayachikitsa |
| Affiliation |
The West Bengal University of Health Sciences |
| Address |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital
294/3/1 A.P.C Road Kolkata
DD 36, 2nd Avenue, DD Block, Sector 1, Bidhannagar, Kolkata, West Bengal 700064
Kolkata
WEST BENGAL
700009
India |
| Phone |
8447804708 |
| Fax |
|
| Email |
mainakb95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government of West Bengal Health and family welfare Swasthya Bhawan GN 29, Sector V, Salt Lake, Kolkata 700 091 |
|
|
Primary Sponsor
|
| Name |
IPGAE and R at SVSP Hospital Kolkata |
| Address |
294/3/1 A.P.C Road, Kolkata West Bengal 700009 |
| 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 Subir Kumar Khan |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital |
Institute of Post Graduate Ayurvedic Education and Research at SVSP Hospital
Department of Kayachikitsa, OPD NO. 1 and Shalya unit OPD no. 4, 294/3/1, A.P.C Road, Kolkata 700009
Kolkata
WEST BENGAL |
8944006115
subirkrkhan2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,IPGAE AND R |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N200||Calculus of kidney. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: APAMARGA KSHARA, Reference: RASA TARANGINI, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: WATER), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18 to 60 years of age group
Patients with clinical signs and symptoms of Mutrashmari as mentioned in classical Ayurvedic texts and modern literature.
Size of calculus less than 10 mm
Patient will be selected irrespective of caste and religion.
Patient willing for the trial. |
|
| ExclusionCriteria |
| Details |
Patients below 18 years and above 60 years.
Size of calculus more than 10mm.
Patient with acute pain.
Chronic kidney disease.
Hydronephrosis.
Pyelonephritis.
Uncontrolled diabetes mellitus.
Uncontrolled hypertension.
Alcoholic.
Lactating or any pregnancy in females.
Patients undergoing hormonal therapy.
Any malignancy.
Any cardiac disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The internal use of apamarga kshara may show improvements
in subjective symptoms such as Pain in abdomen, renal angle, radiating to groin,Haematuria, Burning micturition.
Frequency of micturition.
Associated symptoms fever, nausea, vomiting of mutrashmari |
0TH DAY, 15TH DAY, 30TH DAY, 45TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Inter al use
The internal use of apamarga kshara may show improvements
in objective parameters like CBC,Kidney function test
, Urine analysis (RE & ME)
, Ultrasound KUB
, Straight x-ray abdomen |
0TH DAY, 15TH DAY, 30TH DAY, 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 3 |
|
Date of First Enrollment (India)
|
17/08/2024 |
| 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="3"
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
|
Mutrashmari or urinary stone is the most painful & common disease of the urinary system in human beings. It is the third most common affliction of the urinary tract, exceeded only by UTI and BPH. As per classics Ashmari is included in Ashta mahagada due to its fatal nature. Total 30 patients will be selected and whole sample will be given Apamarga Khsara capsule 500mg twice daily orally for 45 days. The most common presenting symptoms of nephrolithiasis are sudden-onset, flank pain, haematuria, nausea, and vomiting. The pain waxes and wanes in the acute phase and patients are often unable to find a comfortable position and appear writhing in pain. In the present study, Apamarga Paniya Kshara will be used as a remedy in Mutrashmari and have Lekhana(scraping) and Bhedana (cutting) properties, so these are more suitable for Mutrashmari as they help to expel out the Mutrashmari by reducing its size. Necessary assessment parameter will be used here and final assessment and conclusion may be made through statistical analysis. The conclusions will be drawn on the basis of findings at the end of the study by evaluating the findings of subjective and objective parameters. |