| CTRI Number |
CTRI/2023/02/049762 [Registered on: 15/02/2023] Trial Registered Prospectively |
| Last Modified On: |
14/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effect of oral ayurvedic medication in treatment of renal calculus. |
|
Scientific Title of Study
|
Randomised controlled clinical trial to compare the efficacy of patala kshar with combination of kadali kshar and palash kshar in management of mootrashmari. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSHUBHAM KISAN MENGADE |
| Designation |
PG SCHOLAR shalya tantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Department of shalya tantra, Tilak Ayurved Mahavidyalaya, Rasta peth
Centre for post graduate studies & Research in Ayurved of Tilak ayurved Mahavidyalaya, Rasta peth , Pune 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
9922079243 |
| Fax |
|
| Email |
mengadeshubham5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandkishor V Borse |
| Designation |
HOD & Professor , Shalya tantra Dept. |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Department of shalya tantra, Tilak Ayurved Mahavidyalaya, Rasta peth , Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9422032696 |
| Fax |
|
| Email |
drnvborse@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandkishor V Borse |
| Designation |
HOD & Professor , Shalya tantra dept. |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Department of shalya tantra , Tilak Ayurved Mahavidyalaya, Rasta peth ,Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9422032696 |
| Fax |
|
| Email |
drnvborse@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya, Rasta peth, Pune |
|
|
Primary Sponsor
|
| Name |
Tilak ayurved Mahavidyalaya |
| Address |
Centre for post graduate and studies , Tilak ayurved Mahavidyalaya, Rasta peth ,Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shubham Kisan Mengade |
Seth Tarachand charitable ayurvedic hospital |
Seth Tarachand charitable ayurvedic hospital ,opd no 7 &9, Department of surgery, Rasta peth , Pune - 11
Pune
MAHARASHTRA |
9922079243
mengadeshubham5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, Tilak Ayurved Mahavidyalaya,Pune and Seth Tarachand Ramnath Charitable Ayurved Hospital, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N209||Urinary calculus, unspecified. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patala kshara, Reference: Bhavaprakash mutraghat , Route: Oral, Dosage Form: Kshara , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Tila taila & ushnodak), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kadali kshar and palash kshar, Reference: Rasatarangini, Route: Oral, Dosage Form: Kshara , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Size of calculus- A known diagnosed case of renal calculus having calculus 5 to 7
mm.
2) Age group -20 to 60 years with irrespective of gender.
3)Patients ready to give written consent will be selected |
|
| ExclusionCriteria |
| Details |
1. Patient who are suffering from severe systemic disorders
like renal failure, Carcinoma .
2. Known case of DM, HTN, Asthma, HIV, HbsAg.
3. Congenital anomalies of kidney.
4. The pregnant women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in symptoms of urolithiasis such as Abdominal pain, burning micturition, haematuria , also the site , size And number of ashmari |
Baseline , 7thday , 14th day, 21st day , 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence /Reappearance of symptoms of ashmari |
60 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
22/02/2023 |
| 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
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Due to the sedentary lifestyle, unhealthy salt & mineral rich foods, bother to drink
plenty of water, digestive systems gets affected & tridoshas vitiated on reaching the
urinary tract causes ashmari which resembles the kidney stones & various urinary tract
disease. Available western medicines & techniques treat kidney stones with pain
killers, laser treatments, surgical removal which no doubt gives fast relief but on other
hand recurrence leading to long hospital stays rehospitalisation resulting in economical
loses.
Ayurveda the ancient science of life has explained various herbo mineral
remedies.Patala is one of them explained by Acharya Bhavprakash & Sushruta in
mutraghat chikitsa within easy to take cost effective & affordable to all socioeconomic
class.
In Ayurveda number of drugs and formulations are mentioned to treat
Mootrashmari, among them the patala kshar is selected for study as the drug is easily
available and can be given on O.P.D. basis. |