| 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
|
|
|
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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. |