| CTRI Number |
CTRI/2022/10/046162 [Registered on: 04/10/2022] Trial Registered Prospectively |
| Last Modified On: |
03/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Indrayan kalka in renal stone |
|
Scientific Title of Study
|
Randomized open controlled clinical study to evaluate the efficacy of Indrayan kalka in mutrashmari with special reference to Urolithiasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Achal Vijay Kanojia |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC kodoli, shalyatantra department opd no 4 |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli, shalyatantra department opd no 4, kodoli dist kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9096977754 |
| Fax |
|
| Email |
aachalkanaujia19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmi Narhare |
| Designation |
PG Guide, Professor shalyatantra department |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC kodoli, shalyatantra department opd no 4 |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli, shalyatantra department opd no 4, kodoli dist kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822189226 |
| Fax |
|
| Email |
drlaxminarhare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Achal Vijay Kanojia |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC kodoli, shalyatantra department opd no 4 |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli, shalyatantra department opd no 4, kodoli dist kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9096977754 |
| Fax |
|
| Email |
aachalkanaujia19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic Medical College PGT and RC kodoli dist kolhapur Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Achal Vijay Kanojia |
| Address |
Yashwant Ayurvedic Hospital kodoli Kolhapur |
| 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 Achal Vijay Kanojia |
Yashwant Ayurvedic Medical College PGT and RC kodoli |
shalyatantra department opd no 4, kodoli dist kolhapur
Kolhapur
MAHARASHTRA |
9096977754
aachalkanaujia19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N209||Urinary calculus, unspecified. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Indrayan Kalka, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 2(g), Frequency: bd, Bhaishajya Kal: Grasantara bhakta, Duration: 12 Days, anupAna/sahapAna: Yes(details: vasi jal), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Tab Cystone, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Grasantara bhakta, Duration: 12 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Predignosed patient with clinical features and USG showing calculus of size 6mm single or multiple will be taken for treatment.
2) Calculus presents in Kidney/Ureter/Bladder |
|
| ExclusionCriteria |
| Details |
1) Patients with calculus more than 6mm in size.
2) Patients of shukrashmari.
3) Patients having renal failure. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in stone size in mm according to USG |
12 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Decrease in symptoms like
2) pain burning micturition
3) dysuria
4) hematuria |
12 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Randomized open
controlled clinical study to evaluate the efficacy of Indrayan kalka in
mutrashmari with special reference to Urolithiasis .Study will be carried in OPD of Shalyatantra department of Yashwant Ayurvedic College and Hospital Kodoli. The observation would be drawn on the basis of symptoms after treatment given. |