| CTRI Number |
CTRI/2025/06/088822 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to evaluate the effect of two medicines, Pashanabhedadi kwatha and Trikantakadi kwatha in managing urolithiasis |
|
Scientific Title of Study
|
Management of Urolithiasis with Pashanabhedadi Kwatha and Trikantakadi Kwatha- A comparative clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shyama KV |
| Designation |
PhD (Ayu) Scholar |
| Affiliation |
Glocal College of Ayurvedic Medical science and Research Centre |
| Address |
Glocal College of Ayurvedic Medical science and Research Centre
Glocal university
Mirzapur pole
Saharanpur (Dist)
Uttarpradesh
Saharanpur
UTTAR PRADESH
247121
India |
| Phone |
9605145572 |
| Fax |
|
| Email |
kvshyamaraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Remani KK |
| Designation |
Professor |
| Affiliation |
Glocal College of Ayurvedic Medical science and Research Centre |
| Address |
Research dDepartmen t of Kayachikitsa
Glocal College of Ayurvedic Medical science and Research Centre
Glocal university
Mirzapur pole
Saharanpur (Dist)
Uttarpradesh
Saharanpur
UTTAR PRADESH
247121
India |
| Phone |
9447389582 |
| Fax |
|
| Email |
dr.kkremani.ayur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shyama KV |
| Designation |
PhD (Ayu) Scholar |
| Affiliation |
Glocal College of Ayurvedic Medical science and Research Centre |
| Address |
Glocal College of Ayurvedic Medical science and Research Centre
Glocal university
Mirzapur pole
Saharanpur (Dist)
Uttarpradesh
Saharanpur
UTTAR PRADESH
247121
India |
| Phone |
9605145572 |
| Fax |
|
| Email |
kvshyamaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shyama KV |
| Address |
PhD Scholar
Glocal College of Ayurveda and Medical Science and Research Centre, Delhi Yamuntri Marg (State high way 57)Mirzapur pole , Dist-Saharanpur, Uttarpradesh 247121 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shyama KV |
Sumandeep Ayurveda College and Hospital |
Department of Kayachikitsa
OPD Block
Room No.5
Piparia (post)
Vadodara
Vadodara
GUJARAT |
9605145572
kvshyamaraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Glocal university |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N23||Unspecified renal colic. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pashanabhedadi kwatha, Reference: Vangasena Samhita Ashmari adhikara 42nd chapter 64th sloka, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Karkatika,trapusa,shilajatu,guda), Additional Information: karkatika,shilajatu,trapusa and guda will be added as prakshepaka dravya | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trikantakadi kwatha, Reference: Yogaratnakara uttarardha ashmari adhikara sloka no.1, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who have signed informed consent and having urolithiasis with stone size up to 10 ml will be included in the study |
|
| ExclusionCriteria |
| Details |
Subjects with chronic kidney disease, gross hydronephrosis, severe haematuria,stone size more than 10 mm and the subjects with gastritis will be excluded. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasonography of abdomen and pelvis to detect the presence of calculi, size of calculi and number of number of calculi |
Ultrasonography of abdomen and pelvis will be done on 0th day 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective symptoms like pain,burning micturition, dysuria,hematuria,frequency of micturition will be assessed based on the grading in severity of the symptom. |
0th day,20th day,40th day,60th day |
|
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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)
|
01/07/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
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Brief Summary
|
Urolithiasis is formation of urinary calculi at any level of the urinary tract. It is estimated that approximately 2% of the population experiences renal stone disease in their life with male-female ratio 2:1. The peak incidence is observed in 2nd to 3rd decades. Renal calculi are characterized clinically by colicky pain (renal colic) as they pass down along the ureter and may be manifested by hematuria. The most common symptom is colicky pain often associated with macroscopic or microscopic hematuria. The severity of pain may also depend up on the site of occurrence of stone. The pain in urolithiasis is usually severe in nature especially if the stones are moving down to the ureter. Urinary calculi is considered to be the most common and important cause of obstructive uropathy. It also acts as an added risk factor for so many other conditions like Urinary tract infections, Chronic kidney diseases and Hypertension. Urolithiasis is such a disease which is having the maximum chance of reoccurrence and repeatedly undergoing the surgery or any other stone removal technique may adversely affect the whole urogenital system. So if we can manage the condition with oral medication which is explained in Ayurveda classics will be more beneficial for the society. With this intention we have selected the comparative study to evaluate the efficacy of Pashanabhedadi kwatha and Trikantakadi kwatha over subjective and objective parameters of Urolithiasis. The study will be randomized open clinical trial having 2 groups with 50 subjects in each group and the medicine given will be in kashaya form with 96 ml dosage before food 2 times in a day. Null hypothesis: There is no significant difference in the efficacy of managing Urolithiasis between 2 groups. (Group 1 and 2) Alternate hypothesis: There is significant difference in managing urolithiasis between group 1 and group 2 favoring one group over the other in reducing the signs and symptoms of urolithiasis.
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