| CTRI Number |
CTRI/2026/01/101768 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A STUDY TO UNDERSTAND THE EFFECT OF KADALIKANDA PANEEYA KSHARA IN KIDNEY STONE |
|
Scientific Title of Study
|
CLINICAL STUDY TO EVALUATE THE EFFECT OF KADALIKANDA PANEEYA KSHARA IN 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 |
Amit Kumar |
| Designation |
PG Scholar |
| Affiliation |
Pankajakasthuri Ayurveda Medical College & PG Centre |
| Address |
Pankajakasthuri Ayurveda Medical College & PG Centre
Killy Kattakada Trivandrum
Pankajakasthuri Ayurveda Medical College & PG Centre
Killy Kattakada Trivandrum
Thiruvananthapuram
KERALA
695572
India |
| Phone |
7022131996 |
| Fax |
|
| Email |
rathor026@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Kumar.C |
| Designation |
Professor & HOD |
| Affiliation |
Pankajakasthuri Ayurveda Medical College & PG Centre |
| Address |
Pankajakasthuri Ayurveda Medical College & PG Centre
Killy Kattakada Trivandrum
Pankajakasthuri Ayurveda Medical College & PG Centre
Killy Kattakada Trivandrum
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447160480 |
| Fax |
|
| Email |
drsureshtriveni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Kumar.C |
| Designation |
Professor & HOD |
| Affiliation |
Pankajakasthuri Ayurveda Medical College & PG Centre |
| Address |
Pankajakasthuri Ayurveda Medical College & PG Centre
Killy Kattakada Trivandrum
Pankajakasthuri Ayurveda Medical College & PG Centre
Killy Kattakada Trivandrum
KERALA
695572
India |
| Phone |
9447160480 |
| Fax |
|
| Email |
drsureshtriveni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri Ayurveda Medical College & PG Centre Killy Kattakada Trivandrum |
|
|
Primary Sponsor
|
| Name |
Amit Kumar |
| Address |
Pankajakasthuri Ayurveda Medical College and PG Centre Killy Kattakada Thiruvananthapuram |
| Type of Sponsor |
Other [Self ] |
|
|
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 Amit Kumar |
Pankajakasthuri Ayurveda Medical College & PG Centre |
Room No. H04 Department Of Shalya Tantra Killy Kattakada Trivandrum
695572
Thiruvananthapuram
KERALA |
7022131996
rathor026@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: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: KADALIKANDA PANEEYA KSHARA , Reference: SUSRUTHA SAMHITA, Route: Oral, Dosage Form: Kshara , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -JALA), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects with signs and symptoms of urolithiasis and diagnosis confirmed by USG.
2)Size of the Urinary calculi less than 8mm
3)Subjects of both genders irrespective of caste, and socio-economic status
4)Age group 18-65years |
|
| ExclusionCriteria |
| Details |
1)Subjects previously diagnosed with impaired renal functions, malignancy, Tuberculosis of
urinary tract.
2)Subjects with uncontrolled Diabetes mellitus and Hypertension.
3)Subjects who are contraindicated for the intake of Paneeya Kshara as mentioned in
classics.
• Subjects with catheterized bladder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain
2. Burning micturition
3. Dysuria
4. Tenderness in renal angle |
primary outcome will be made on 0th , 15th and 30th day. Follow up assessment will be done on 45th day.
Assessment of the size of the Urinary calculi by USG will be done on 0th (before treatment) and 30st day (after treatment).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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 2 |
|
Date of First Enrollment (India)
|
31/01/2026 |
| 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
|
CLINICAL STUDY TO EVALUATE THE EFFECT OF KADALIKANDA PANEEYA KSHARA IN UROLITHIASISUrolithiasis is a disease which if untreated may lead to permanent damage to the kidney functions. In Modern science, medical treatment of urinary calculi includes dietary management, stone-specific therapies, and medical expulsion of calculi. The conservative management includes chemical dissolution of urinary stones which requires indwelling urinary catheters for constant irrigation. Sometimes the stone-fragments may occlude the urinary catheter and cause acute obstruction. According to Ayurveda, Ashmari is a dreadful disease similar to anthaka. it is to be treated with medicine if recent and when increased in size it requires Chedana. The Ahsmarihara Yogas when used in the initial stage of urinary stone reduces the chance of surgery. In Ayurveda although various medications are available to treat urinary calculi, which contain many drugs, some of which are unavailable in the present day. |