| CTRI Number |
CTRI/2024/12/078629 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the effect of Shatavaryadiras (oral administration) in Mutrashmari with special refrence to Urolithiasis |
|
Scientific Title of Study
|
Randomized Open Controlled Clinical Study to evaluate the efficacy of Shatavaryadiras in Mutrashmari with special reference to 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 |
DrSonali Birudev Gadade |
| Designation |
PG SCHOLAR |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 3rd floor Yashwant Ayurvedic College Post Graduate Training and Research Center, Tal Panhala , Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8087300353 |
| Fax |
|
| Email |
sonaligadade4417@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sayaji Bapu Desai |
| Designation |
PG Guide |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 3rd floor Yashwant Ayurvedic College Post Graduate Training and Research Center, Tal Panhala , Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423282354 |
| Fax |
|
| Email |
drsayaji@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSonali Birudev Gadade |
| Designation |
PG SCHOLAR |
| Affiliation |
Yashwant Ayurvedic College Post Graduate Training and Research Center Kodoli |
| Address |
OPD No 4 Shalyatantra department 3rd floor Yashwant Ayurvedic College Post Graduate Training and Research Center, Tal Panhala , Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8087300353 |
| Fax |
|
| Email |
sonaligadade4417@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD Patients Yashwant Ayurvedic Medical college kodoli kolhapur 416414
Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Sonali Birudev Gadade |
| Address |
OPD No 4 Shalyatantra department 3rd floor Yashwant Ayurvedic College Post Graduate Training and Research Center, Tal Panhala , Dist Kolhapur 416114
India |
| 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 Sonali Birudev Gadade |
Yashwant Dharmartha Rugnalay Kodoli |
Opd no 4 Shalyatantra department 2nd floor Yashwant Ayurvedic College Post Graduate Training and Research Center, Kodoli
Kolhapur
MAHARASHTRA |
8087300353
sonaligadade4417@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT& RC Kodoli |
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: MUTRA-VEGARODHAH/MUTRAGRAHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatvaryadiras , Reference: Yogratnakar , Route: Oral, Dosage Form: Swaras/ Juice, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Tb.Cystone, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Ureteric, kidney, bladder
calculus of size from 4 mm to 6 mm single or multiple or bilateral calculus
will be taken for treatment.
2)Vataj Ashmari Pittaj Ashmari Kaphaj Ashmari with known case of mutrashmari
3)Patient with controlled DM and HTN
4)Grade 1 hydronephrosis |
|
| ExclusionCriteria |
| Details |
1)Calculus more than 6 mm
2)Medical cause of haematuria like bleeding disorders,
glomerulonephritis, IgA, Nephropathy, drug induced haematuria etc.
3)K/C/O Uterine, Cervical, Vaginal, Urethral malignancy or any suspected
malignancy, active genital herpes
4)Patients having other disorders like STD’S , Gout, Hyperthyroidism.
5)K/C/O HIV, HBsAg, chronic lung disease, BPH
6)Renal failure.
7)Case which required any other surgical intervention
8)Chronic Urine retention, Severe hydronephrosis, Parathyroidism ,
Pyelonephritis
9)Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the efficacy of Shatavaryadiras in Mutrashmari with reference to urolithiasis |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study the probable mode of action of Shatavaryadiras
2)To study critical review of urolithiasis
3)To study adverse effect of Oral administration of Shatavaryadiras
4)To achieve the result in 21 days |
21 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
04/01/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is open randomized controlled clinical trial study to evaluate the efficacy of Shatavaryadiras in Mutrashmari with special refrence to Urolithiasis. This study will be carry in OPD of Shalyatantra department of Yashwant Ayurvedic College and hospital kodoli. Observation would be drawn on the basis of symptoms after treatment given. |