| CTRI Number |
CTRI/2022/01/039811 [Registered on: 28/01/2022] Trial Registered Prospectively |
| Last Modified On: |
28/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of ayurvedic syrup in kidney stone |
|
Scientific Title of Study
|
CLINICAL EFFICACY OF CHINCHAKSHAR IN THE MANAGEMENT OF 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 Suhas Vishvakant Vibhute |
| Designation |
PG Scholar |
| Affiliation |
Ayurved seva sangh ayurved mahavidyalaya |
| Address |
OPD No 6, Shalya tantra opd
Nashik
MAHARASHTRA
422203
India |
| Phone |
9604095250 |
| Fax |
|
| Email |
suhasvvibhute@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay Sonambekar |
| Designation |
Professor and Head |
| Affiliation |
Ayurved seva sangh ayurved mahavidyalaya |
| Address |
OPD No 6, Shalya tantra opd
Nashik
MAHARASHTRA
422203
India |
| Phone |
9822624890 |
| Fax |
|
| Email |
sonambekar.chinmay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinay Sonambekar |
| Designation |
Professor and Head |
| Affiliation |
Ayurved seva sangh ayurved mahavidyalaya |
| Address |
OPD No 6, Shalya tantra opd
Nashik
MAHARASHTRA
422203
India |
| Phone |
9822624890 |
| Fax |
|
| Email |
sonambekar.chinmay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
|
|
Primary Sponsor
|
| Name |
DR SUHAS VISHVAKANT VIBHUTE |
| Address |
AYURVED SEVA SANGHA ,AYURVED MAHAVIDYALAYA NASHIK
|
| 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 SUHAS VISHVAKANT VIBHUTE |
AYURVED SEVA SANGHA ,AYURVED MAHAVIDYALAYA ,NASHIK |
OPD NO 6,SHALYATANTRA
Nashik
MAHARASHTRA |
9604095250
suhasvvibhute@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,Ayurved mahavidyalaya, Arogyashala rugnalaya ,Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N202||Calculus of kidney with calculus of ureter. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: CHINCHAKSHAR, Reference: RASATARANGINI, Route: Oral, Dosage Form: Kshara , Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: WATER), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: CYSTONE, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 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 |
Patients diagnosed as a case stone of KUB
Patient having calculi size in between 3-10 mm patient giving consent for participating in study
|
|
| ExclusionCriteria |
| Details |
Patient having calculi size greater than 10 mm
Patient having chronic or acute kidney disorders
Patient having obstructive uropathy
Patient having Malignancy disorder of KUB
Patient is known case of hyperparathyroidism.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in renal colic pain
Reduction in size of calculi |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COST EFFECTIVE and EASY TO PREPARE |
30 days |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diagnosed Calculus in KUB will be treated with 2 Groups, group A- Controlled Group DRUG– Tab.Cystone 2 Tab.(500mg) BD , Twice a day with water for 30 Days , and group B –TRIAL GROUP DRUG:-CHINCHAKSHAR 10ml BD Twice daily After meal with water for 30 Days and total no of patients will be 50 in each group, assessment criteria for study will be the Patients fulfilling diagnostic criteria and signs and symptoms of Mutrashmari.Patients those willing to participate in the study, Age between 20 to 60 yrs ,Both male and female,diagnosed patients of renal calculus,calculi size in between 3-10 mm and patient having calculi size greater than 10 mm,chronic or acute kidney disorders, obstructive uropathy, maligancy disorder of KUB will be excluded from the study.Patients will be taken for study from opd no 6 shalyatantra department .
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