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CTRI Number  CTRI/2025/09/094449 [Registered on: 09/09/2025] Trial Registered Prospectively
Last Modified On: 08/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative evaluation of aparveerataradi oil enema and aparveerataradi oil enema along with arkapushpipaste tablet in renal stone disease(urolithiasis) 
Scientific Title of Study   Comparative evaluation of aparveerataradi tailam matra basti and aparveerataradi tailam matra basti along with arkapushpikalka ghanvati in 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 Vishal Verma 
Designation  Professor 
Affiliation  Rishikul Campus, Uttarakhand Ayurved University, Haridwar 
Address  OPD No. 7, Deptt. of Shalya Tantra, Rishikul Ayurvedic hospital, Rishikul campus, Uttarakhand Ayurved University, Haridwar Hardwar UTTARANCHAL 249401 INDIA

Hardwar
UTTARANCHAL
249401
India 
Phone  09719314634  
Fax    
Email  Vishalverma100@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vishal Verma 
Designation  Professor 
Affiliation  Rishikul Campus, Uttarakhand Ayurved University, Haridwar 
Address  OPD No. 7, Deptt. of Shalya Tantra, Rishikul Ayurvedic hospital, Rishikul campus, Uttarakhand Ayurved University, Haridwar Hardwar UTTARANCHAL 249401 INDIA

Hardwar
UTTARANCHAL
249401
India 
Phone  09719314634  
Fax    
Email  Vishalverma100@gmail.com  
 
Details of Contact Person
Public Query  
Name  Deeksha Sati 
Designation  PG Scholar 
Affiliation  Rishikul Campus, UAU, Haridwar 
Address  OPD No. 7, Deptt. of Shalya Tantra, Rishikul Ayurvedic hospital, Rishikul campus, Uttarakhand Ayurved University, Haridwar Hardwar UTTARANCHAL 249401 INDIA

Hardwar
UTTARANCHAL
249401
India 
Phone  7906824572  
Fax    
Email  deekshasati.112@gmail.com  
 
Source of Monetary or Material Support  
OPD NO. 7, RISHIKUL CAMPUS, UTTARAKHAND AYURVED UNIVERSITY, HARIDWAR, UTTARAKHAND, INDIA pin code- 249401 
 
Primary Sponsor  
Name  Uttarakhand Ayurved University 
Address  Uttarakhand Ayurved University, Harrawala, Dehradun, uttarakhand Pin code - 248001 
Type of Sponsor  Government medical college 
 
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 
Deeksha Sati  Rishikul Campus, UAU, Haridwar  OPD No. 7, Deptt. of Shalya Tantra, Rishikul Ayurvedic hospital, Rishikul campus, Uttarakhand Ayurved University, Haridwar Hardwar UTTARANCHAL 249401 INDIA
Hardwar
UTTARANCHAL 		 07906824572

deekshasati.112@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N209||Urinary calculus, unspecified. Ayurveda Condition: ASMARI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charak siddhi sthan 3/24, Procedure details: Pradhan krama Cleaning of anal region with betadine gauze. Then patient is allowed to lie down in left lateral position. Then 30 ml of aparveerataradi tailam is pushed into the anal canal with the help of plain rubber catheter. After that patting over the buttock region will be then. And patient will be allowed to rest for 5-10 min for proper abosorption of oil.)
(1) Medicine Name: APARVEERATARADI TAILAM, Reference: Bhaw prakash madhyam khand 37/91-94, Route: Rectal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 21 Days
2Intervention ArmDrugClassical(1) Medicine Name: ARKAPUSHPIKALKA GHANVATI , Reference: Yog ratnakar ashmari chikitsa / 1, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Ushna Jal), Additional Information: PREPARATION OF GHANVATI Fresh Shewta Arka Pushp are taken Mardana of Arka Pushpi panchang is done with adding Godugdh in it Paste is prepared Now mould it into Vati form Dried under shade
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Classical symptoms of Ashmari.
2.Radiological evidence of calculus (up to 8 mm) in kidney, ureter, urinary bladder & urethra
3.Patients of both sex, irrespective of religion, socioeconomic status and occupation will be taken

 
 
ExclusionCriteria 
Details  1. Pregnant women and lactating mothers will be excluded
2.Calculi of size more than 8 mm.
3.Patients of Ashmari having systemic diseases like RHD, AIDS and Hepatitis B.
4.Complications related to Kidneys/ Ureter / Bladder like - Acute Renal failure.
5.
Chronic Renal Failure, Polycystic Kidney diseases, Impaired Renal function, etc.
6.Patients having moderate or severe Hydronephrosis will be excluded
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Outcome will be measured by parameters :
1 Pain
2. Burning Micturition
3. Dysuria
4. Frequency of Micturition
5. Hematuria
 		 Outcome will be evaluated every 7th day for 3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. No. of calculi on the basis of USG KUB
2. Size of calculus ( acc. to USG before and after treatment)
 		 Outcome will be evaluated every 7th day for 3 weeks 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   28/09/2025 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [deekshasati.112@gmail.com].

  6. For how long will this data be available start date provided 10-09-2025 and end date provided 10-11-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Selected Drug :  Arkapushpikalka Ghanvati and Aparveerataradi Tailam

 

Form of medicine: Arkapushpikalka will be given in the form of ghanvati and Aparveerataradi Tailam  will be given in the form of Matra Basti as explained in classical text.


Composition of medicine : 

ARKAPUSHPIKALKA GHANVATI  : - 1. Shweta Arka Pushpi panchang

                                                                  2. Godugdh

APARVEERATARADI TAILAM :-         Pashanbhed

1.Veervruksh Bark  2. Pashanbhed Panchang 3. Arani Root Bark, Leaves 4. Shyonaka Root Bark  5. Patla Root Bark 6. Vrikshadani Whole Plant 7. Eranda Leaves, Root 8. Vetra Root 9. Swarnkshiri Panchang 10. Usher Mool 11. Padmak Seeds And Bark 12. Kusha Mool 13. Kaas Mool 14. Shar Mool 15. Kshudra Agnimantha Root Bark 16. Ikshu Mool 17. Aparajita Panchang 18. Kokilaksha Seeds 19. Shatavari Mool 20. Gokshur Seeds 21. Kapotvanka Panchang 22. Itkat Flowers, Leaves 23. Gambhari Mool

Preparation of medicine:- Arkapushpikalka Ghanvati and Aparveerataradi Tailam matra Basti will be prepared according to classical views.


 Dose of medicine :- Arkapushpikalka Ghanvati - 1 Tablet BD [500 mg]

                                 Aparveerataradi Tailam Matra Basti – 30 ml for 21 days


Route of Administration :- Ghan vati – oral

                                           Matra Basti – Per Rectal

 

 
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