| CTRI Number |
CTRI/2023/09/058001 [Registered on: 25/09/2023] Trial Registered Prospectively |
| Last Modified On: |
21/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study to evaluate the effect of Mulasi powder and Gokshur powder in kidney stone |
|
Scientific Title of Study
|
Randomised controlled clinical trial to compare add on effect of musali churna and gokshur churna with gokshur churna in the management of mootrashmari |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gopal B Kute |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra, Tilak Ayurved Mahavidyalaya Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
7558266528 |
| Fax |
|
| Email |
kutegopal.gk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanraj Gaikwad |
| Designation |
Associate professor , Shalyatantra Department |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Department of shalyatantra, Tilak Ayurved Mahavidyalaya Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9422342048 |
| Fax |
|
| Email |
draj.gaikwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanraj Gaikwad |
| Designation |
Associate professor , Shalyatantra Department |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Department of shalyatantra, Tilak Ayurved Mahavidyalaya Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9422342048 |
| Fax |
|
| Email |
draj.gaikwad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand ramnath charitable ayurvedic hospital pune |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya,Rasta Peth,Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gopal Kute |
Seth Tarachand Ramnath Mahavidyala |
Tilak Ayurveda Mahavidyalaya Department of Shalyatantra OPD No.7,Rasta Peth Pune
Pune
MAHARASHTRA |
7558266528
kutegopal.gk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tilak Ayurved Mahavidyalaya Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N30-N39||Other diseases of the urinary system. Ayurveda Condition: MUTRAKRUCCRAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Musali Churna, Reference: Bhaishajya ratnavali 36/18, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -vyushit jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gokshur churna, Reference: Sushrut chikitsasthan adhyay 7, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -vyushit jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Size of calculus -A known diagnosed case of renal calculus having calculus 4 to 6 mm |
|
| ExclusionCriteria |
| Details |
Patient who are suffering from severe systemic disorders like renal failure, carcinoma
Known case of DM HTN asthma HIV HbsAg
Congenital anomalies of kidney
The pregnant woman |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sadaha mootra pravrutri
Sarakta mootra pravrutri
Udarshool (Site and intensity)
site of ashmari |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Size of stone
Site of stone
No of stone |
3 months |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
04/10/2023 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Renal stone is a painful condition that affects 1 – 2% of the general population. Kidney stones are aggregates of crystals mixed with a protein matrix that cause obstruction of urine flow in the renal collecting system, ureters, or urethra and result in severe pain, leads to increased urinary bleeding, or local erosion of kidney tissues. The formation of stones in the urinary tract is a common and important problem that must be considered in daily urological practice. With a prevalence of>10% and an expected recurrence rate of 50%, stone disease has an important effect on the health care system. Alternatively, the increased urinary volume could decrease the concentration of inhibitors of stone formation. There are various treatment modalities Present for mootrashmari (Renal Calculus) in modern as well are in ayurveda. No work done over effect of Musalichurna in mootrashmari Hence this topic is chosen to evaluate the add on effect of musalichurna along with gokshurchurna in management of mootrashmari. |