| CTRI Number |
CTRI/2024/07/069906 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Renal Stone through ayurvedic line of Management |
|
Scientific Title of Study
|
A Controlled Clinical Study To Evaluate The Efficacy Of Thila Kshara Vida Lavana Yoga Over Apamarga Kshara In The Management Of Mutra Ashmari (Urolithiasis) |
| 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 Archana M P |
| Designation |
2nd year MS [Ayu] Scholar |
| Affiliation |
Shri Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies and Research Center |
| Address |
Shri Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies and Research Center
Gavimath Campus opp to Gavimath
Koppal
KARNATAKA
583231
India |
| Phone |
7026453799 |
| Fax |
|
| Email |
dr.archanamalipatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR B S Savadi |
| Designation |
Professor and HOD Department of Shalya Tantra |
| Affiliation |
Shree jagadguru gavisiddeshwara ayurvedic medical college |
| Address |
Shri Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies and Research Center
Gavimath Campus opp to Gavimath
Koppal
KARNATAKA
583231
India |
| Phone |
9845646885 |
| Fax |
|
| Email |
drbssavadi123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR B S Savadi |
| Designation |
Professor and HOD Department of Shalya Tantra |
| Affiliation |
Shree jagadguru gavisiddeshwara ayurvedic medical college |
| Address |
Shalya Tantra OPD Room No - 16, Shri Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies and Research Center
Gavimath Campus opp to Gavimath
Koppal
KARNATAKA
583231
India |
| Phone |
9845646885 |
| Fax |
|
| Email |
drbssavadi123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree jagadguru gavisiddheshwara ayurvedic medical college post graduate studiesand research centre
Koppal - 583231
Dist - Koppal,
Karnataka,
India. |
|
|
Primary Sponsor
|
| Name |
Department of Shalya Tantra Shree jagadguru gavisiddeshwara ayurvedic medical college |
| Address |
Shree jagadguru gavisiddeshwara ayurvedic medical college postgraduate studies and research center Gavimath Campus opp to Gavimath, Koppal
Pin - 583231
Dist - Koppal,
State - Karnataka
Country - India |
| 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 Archana M P |
Shree jagadguru gavisiddeshwara ayurvedic Medical college and Hospital |
Shalya Tantra OPD, Room No - 16, Shri Jagadguru Gavisiddeshwara Ayurvedic Medical College Post Graduate Studies and Research Center
Gavimath Campus opp to Gavimath
Koppal
KARNATAKA |
7026453799
dr.archanamalipatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N23||Unspecified renal colic. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: tila kshara vida lavana yoga, Reference: prof. kasheenathshastri. shloka no - 86, 4th taranga,rasa tarangini. pranacharya shreesadanandasharmana virachith varanasi motilal banarasidas, Route: Oral, Dosage Form: Kshara , Dose: 750(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Apamarga Kshara, Reference: Sushruta samhita, Route: Oral, Dosage Form: Kshara , Dose: 750(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patients of either gender and age group between 18-60 years with renal caculi size of 4mm to 8mm.
2. vesicle calculi size of 6 mm to 12 mm, and ureteric calculi size of 3mm to 6mm number of calculi less than or equal to 3 and bilateral |
|
| ExclusionCriteria |
| Details |
Patients suffering from Urolithiasis which is associated with other Renal diseases like renal failure acute renal failure and chronic renal failure severe hydronephrosis Renal Tuberculosis Polycystic kidney Neoplasm Obstructive uropathy history of Urethral bleeding Hematuria Patients with high renal parameters like serum creatinine high than normal range Patients who are known case of ischemic heart disease Uncontrolled type 2 diabetes mellitus and hypertension |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the reduction in the size of the stone |
61days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the reduction in size of the calculi |
42 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
18/07/2024 |
| 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="0"
Months="8"
Days="15" |
|
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 is one of the most common disease of the mutravaha srotas. It is one among Ashta Mahagadas. This shows that the mutrashmari disease prevailed since the inception of medicine in India. Majority of the signs and symptoms of the disease mutrashmari resembles with that of Urolithiasis. It occurs more frequently in men than in women, because of different dietary habits or genetic background and it is rare in children*. Research statistics shows that in India, 12% of the people is estimated to have urinary stones, out of which 50% of the population are severely affected by renal damage, which even leads to a failure of kidneys. It is peak in population aged over 30 years". Urolithiasis is a stone-like body composed of urinary salts bound together by a colloid matrix of organic materials. It consists of a nucleus around which concentric layers of urinary salts are deposited*. And has clinical features - Pain, haematuria, frequency. The treatment principle in urolithiasis in contemporary science is flush therapy in case of stones up to 5mm, in larger stones the percutaneous procedure like ESWL (Extracorporeal shock wave lithotripsy) and PCNL (percutaneous nephrolithotomy), URS(Ureteroscopy) and operations like Pyelolithotomy, Nephrolithotomy, nephrectomy are done. These are limited to urban areas and is expensive. There is 40-50% recurrence rate of urolithiasis even after treatment’°. For this reason, efforts are being made to evolve an effective formulation for the treatment as well as for the prevention of recurrence of calculi. Ashmari is kapha ashrita vyadhi, which is caused by not taking panchakarma samshodana therapies and by not following pathya where kapha dosha aggravates and aggravated kapha dosha with vata and mutra enters basti and cause ashmari. Then develops symptoms like pain, haematuria, split urine stream, dysuria, generalized weakness, anorexia. Even though a number of ashmarighna yogas have been mentioned in the classical texts of Ayurveda, only a few formulation have been made available in the day-to-day practices and others are not even known and revalidated clinically. Among them tila kshara vida lavana yoga is also one which is explained in Rasatarangini. Acharya Sushruta mainly explained about kshara in the conservative management of mutrashmari, and also advised tila in the chikitsa of mutraashmari.? Ingredients of Tila kshara vidalavana yoga has the properties of ashmari bhedana by its teekshna and sookshma property; vataanulomaka and kapha dosha hara and agnidipana by its sakshara and ushna property; shulanashana (udarashula) and mutrala.384 As Apamarga kshara has already proven to be effective in the management of mutraashmari, hence in the present work, an attempt will be made to evaluate the efficacy of tila kshara vida lavana yoga in the management of mutraashmari over apamarga kshara. |