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CTRI Number  CTRI/2025/07/091445 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of arka preparation of kushmanda(Ash gourd) in renal calculi. 
Scientific Title of Study   Effect of kushmanda arka in renal calculi 
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 JIJIN J P 
Designation  PG Scholar 
Affiliation  Govt Ayurveda College Kannur 
Address  Department of shalyatantra Govt Ayurveda College Pariyaram Kannur
Govt Ayurveda College Pariyaram Kannur
Kannur
KERALA
670503
India 
Phone  8921790792  
Fax    
Email  drj10695@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Gangadharan 
Designation  Professor  
Affiliation  Govt Ayurveda College Kannur 
Address  Department of shalyatantra Govt Ayurveda College Pariyaram Kannur
Dept of Shalyatantra Govt Ayurveda College Pariyaram Kannur
Kannur
KERALA
670503
India 
Phone  9447876659  
Fax    
Email  drkganga@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr JIJIN J P 
Designation  PG Scholar 
Affiliation  Govt Ayurveda College Kannur 
Address  Department of shalyatantra Govt Ayurveda College Pariyaram Kannur
Govt Ayurveda College Pariyaram Kannur
Kannur
KERALA
670503
India 
Phone  8921790792  
Fax    
Email  drj10695@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  JIJIN J P 
Address  PG Scholar Dept of Shalyatantra Govt Ayurveda College Kannur kerala, India Pin : 670503 
Type of Sponsor  Other [Self funding] 
 
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 JIJIN J P  Govt Ayurveda College Pariyaram, Kannur  OPD and IPD of Department of shalyatantra Govt Ayurveda College Pariyaram Kannur
Kannur
KERALA 
8921790792

drj10695@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurveda College Kannur   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: Kushmanda arka, Reference: Arkaprakasam, Route: Oral, Dosage Form: Arka, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Yavakshara and Hingu), Additional Information: Yavakshara-400mg Hingu-1.5gm
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects diagnosed with signs and symptoms of renal calculi.
Subjects have renal calculi screened with USG.
Renal calculi of size below 10mm.
 
 
ExclusionCriteria 
Details  Ureteric stone
Hydronephrosis
Pyelonephritis
BPH
Polycystic kidney disease
Malignancy of urogenital system
Congenital anomalies of urogenital system
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pain
Burning micturition
Tenderness in renal angle
Size of calculi- USG abdomen and pelvis 
Assessment on 0th,10th,20th and 31st days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   05/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/08/2025 
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  
The dissertation titled “Effect of Kushmanda Arka in Renal Calculi” by Dr. Jijin J P, under the guidance of Dr. K. Gangadharan at Government Ayurveda College, Kannur, explores the therapeutic efficacy of Kushmanda Arka in managing renal calculi (kidney stones), a prevalent and recurrent urological condition.

Renal calculi, often presenting with symptoms like pain, burning micturition, and hematuria, correspond to Ashmari in Ayurvedic literature. While modern management includes invasive procedures, Ayurveda offers conservative remedies that are cost-effective and less disruptive. Kushmanda Arka, derived from Benincasa hispida, along with Hingu (Ferula foetida) and Yavakshara (alkali preparation from barley), is referenced in Arkaprakasa for its potential efficacy in Ashmari due to its diuretic, anti-inflammatory, and litholytic properties.

This interventional pre-post clinical study involves 28 participants aged 20–60 years with renal calculi less than 10 mm, selected from OPD/IPD of the Shalyatantra Department. Participants receive 15 ml of Kushmanda Arka mixed with 30 ml warm water, 1.5 g Hingu, and 400 mg Yavakshara, twice daily for 30 days. Symptom assessment occurs on days 0, 10, and 20, while USG evaluation of stone size is done on days 0 and 31. A follow-up is scheduled on day 61.

The study aims to evaluate both symptom relief and reduction in stone size using validated assessment tools. Data will be analyzed using SPSS software with appropriate statistical tests (t-test, Wilcoxon, chi-square).

This research proposes a safe, effective, and accessible Ayurvedic alternative for managing renal stones, especially for early or recurrent cases, offering promising outcomes in non-invasive care. The study is ethically approved, self-funded, and follows proper clinical protocol.
 
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