FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090174 [Registered on: 04/07/2025] Trial Registered Prospectively
Last Modified On: 02/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   "A Study to Compare the Effects of Two Herbal Remedies in Treating Kidney Stones" 
Scientific Title of Study   A comparative clinical study to evaluate the effect of Eladi kashaya and Pashanabhedadi kashaya in Urolithiasis (Mootraashmari) 
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 Aswani k v 
Designation  Ph.D (Ayu) Scholar 
Affiliation  Glocal University 
Address  Department of Shalya Tantra Glocal college of Ayurvedic medical sciences & Research center, room no 2, shalya opd Delhi - Yamunotri Marg,mizapur pole, Dist Saharanpur, UP

Saharanpur
UTTAR PRADESH
247121
India 
Phone  9496681028  
Fax    
Email  aswanibhaskaran@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.THOMAS T 
Designation  PROFESSOR 
Affiliation  Glocal University 
Address  Research Department of Shalya Tantra Glocal College of Ayurvedic Medical sciences & Research center Delhi - Yamunotri Marg,mizapur pole, Dist Saharanpur, UP

Saharanpur
UTTAR PRADESH
247121
India 
Phone  9447461490  
Fax    
Email  drthomas55@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aswani k v 
Designation  Ph.D (Ayu) Scholar 
Affiliation  Glocal University 
Address  Department of Shalya Tantra Glocal college of Ayurvedic medical sciences & Research center, room no 2, shalya opd Delhi - Yamunotri Marg,mizapur pole, Dist Saharanpur, UP

Saharanpur
UTTAR PRADESH
247121
India 
Phone  9496681028  
Fax    
Email  aswanibhaskaran@gmail.com  
 
Source of Monetary or Material Support  
Gangaputra Ayurveda Medical college and Hospital, kaithal road, kandela,jind haryana, 126102 
 
Primary Sponsor  
Name  DrAswani k v 
Address  Ph.D scholar, Department of Shalya Tantra, Glocal Ayurvedic sciences and research center Mirzapur Pole, Saharanpur (UTTAR PRADESH) 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pooja Arya  Gangaputra Ayurveda Hospital & Research center  Department of Shalya Tantra,shalya opd block,Room No:04, Kandela, Jind Haryana, 126102.
Jind
HARYANA 		 7988699382

dr.arya.pooja94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical Committee Gangaputra Ayurveda college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N22||Calculus of urinary tract in diseases classified elsewhere. Ayurveda Condition: ASMARI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Elaadi kashyam, Reference: 12.Śārṅ gadhara Srikanthamurthy, K. R. (2016). Śārṅ gadhar-saṃhitā : Madhyama khanda – Kwataha kalpana, 5th ed Chaukhambha Orientalia., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: shilajatu choornam), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: pashanabhedadi kashyam, Reference: Laxmipathy sastri,Brahmasankar sastri(1973) Yogarathanakara vidyothiniteeka;2nd ed,Mootraghata chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: dadhi), Additional Information: -
3Comparator ArmDrugClassical(1) Medicine Name: pashanabhedadi kashyam, Reference: Laxmipathy sastri,Brahmasankar sastri(1973) Yogarathanakara vidyothiniteeka;2nd ed,Mootraghata chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: dadhi), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Age of patients 18 to 70 years.
2. Ultrasonography evidence of the stone
3. Patients with signs and symptoms of Mootraashmari
4. Stone size up to 10 mm
5. Crystals of stone.
6. Urolithiatic patients with controlled Hypertension and Diabetic Mellitus
7. Patients with written consent 
 
ExclusionCriteria 
Details  1. Renal failure
2. Gross Hydronephrosis
3. Acute pain abdomen
4. Severe Haematuria
5. Stone size more than 10 mm.
6. Known cases of Malignancy
7. Known cases of Tuberculosis, HIV, VDRL, Hepatitis-B positive 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
USG of Abdomen and pelvis and Microscopic examination of urine will be analyzed.
carried out. 		 USG of Abdomen and pelvis and Microscopic examination of urine will be analyzed on 0th day and 60thday will be carried out. 
 
Secondary Outcome  
Outcome  TimePoints 
Subjective parameters like Pain and Burning micturition will be recorded  on 0th, 15th, 30th, 45th and 60
th day 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   15/07/2025 
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="0"
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  
Urolithiasis is one of the most common diseases of urinary tract. Urolithiasis refers to formation of stones in anywhere in the urinary system including kidney, ureter and bladder. In developing countries like india prevalence of urolithiasis is increasing day by day
with a prevalence of about 12% world wide. Their prevalence in India also reflects worldwide prevalence and stands approximately 12%. Approximately 2 million people in India is affected with nephrolithiasis every year and some parts of country has
denoted the name that "stones belt" occupies parts of Maharashtra, Gujarat, Rajasthan, Punjab, Haryana, Delhi and states of north-east. In India. Surgical treatment plays a crucial role in managing kidney stones, especially for larger stones or those causing obstruction or
severe symptoms.But non surgical treatments have several draw back like increased size, location, anatomical and pain management limitations To avoid the incidence of recurrence after surgical removal of stone and in search of an effective
conservative treatment the present work will be designed..
Research design: – Comparative clinical study with pre and post test.The study will be an open clinical trial having 2 groups having 50 patients each, patients will be randomly allocated to each group for evaluation irrespective of gender, caste, socio economic status if the inclusion and exclusion criteria meets.
Group1-Eladi Kashaya will be given 96 ml twice a day
Group 2-Pashanabhedadi Kashaya will be given 96ml twice a day
HYPOTHESIS:
Null hypothesis:
There is no significant difference in the effect of management of Urolithiasis with Eladi Kashaya and Pashanabhedadi Kashaya .
Alternative hypothesis:
There is significant difference in the effect of management of Urolithiasis with Eladi Kashaya and Pashanabhedadi Kashaya

 
Close