| CTRI Number |
CTRI/2024/11/077414 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study The Efficacy Of GokshurkadiChurna In Management Of Mutrashmari |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Study The Efficacy Of GokshurakadiChurna In Management Of Mutrashmari
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niraj Vitthalrao Adhe |
| Designation |
PG Scholar MS Shalyatantra |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed,Ratnagiri
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9309727402 |
| Fax |
|
| Email |
adheniraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Devidas Pawar |
| Designation |
Associate Professor |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed,Ratnagiri
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9822285836 |
| Fax |
|
| Email |
dr.ashok2575@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niraj Vitthalrao Adhe |
| Designation |
PG Scholar MS Shalyatantra |
| Affiliation |
MES Ayurved Mahavidyalaya |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed,Ratnagiri
Ratnagiri
MAHARASHTRA
415722
India |
| Phone |
9309727402 |
| Fax |
|
| Email |
adheniraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| MES Ayurved Mahavidyalaya & attached Parshuram Hospital & Research Center,
Ghanekhunt Lote, Khed, Ratnagiri, Maharashtra, India-415722. |
|
|
Primary Sponsor
|
| Name |
Dr Niraj Vitthalrao Adhe |
| Address |
MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri,415722 |
| 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 Niraj Vitthalrao Adhe |
MES Parshuram Hospital |
Department of
Shalyatantra ,OPD No
1, Parshuram Hospital,
Ghanekhunt Lote,Khed.
Ratnagiri
MAHARASHTRA
Ratnagiri
MAHARASHTRA |
9309727402
adheniraj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MES AYURVED MAHAVIDYALAYA ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N22||Calculus of urinary tract in diseases classified elsewhere. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gokshurkadi churna, Reference: Harit Samhita 31 St chapter , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -mahishdugdha), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pashanbhed churna, Reference: Ashtanga sangraha sutrasthan chapter number 15, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -jaal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients Having Signs And Symptoms Of Mutrashmari.
2) Patients Of Both Sex Will Be Included.
3) Patients Between Age Group 18 To 60 Year Will Be Included .
4) Calculus Of Size Up To 12mm Without Any Residual Complications.
5) Presence Of Stone In Any Location Of Urinary Tract. |
|
| ExclusionCriteria |
| Details |
1) Pyonephrosis, Ca Of Urinary Tract.
2) Severe Haematuria.
3) Having Calculus Of Size More Than 12 Mm
4) Pregnant And Lactating Women.
5) Obstructive Uropathy Leading To Gross Hydro Nephrosis, Renal Function Impairment.
6) Known Patients Of Dm, Uncontrolled Htn,Hypotension Systemic Disease Like Tb, Hiv-Positive, Cardiovascular Disorders And Other Major Systemic Illness. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Efficacy Of Gokshurkadi Churna In The Management Of Mutrashmari. |
21 days study with follow up on 1st 7th 14th 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To Find Out Whether This Drug Reduces The Size Of Mutrashmari Or Promotes Its Expulsion.
2. To Establish The Better Medicinal Alternative In The Management Of Mutrashmari.
3.To Find Out Its Effect On The Symptoms Of Mutrashmari.
4.To Find Out Whether This Drug Shortens The Duration Of Treatment Of Mutrashmari Than Other Drug. |
21 days study with follow up on 1st 7th 14th 21st day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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 - 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 - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 - Proposals should be directed to [adheniraj@gmail.com].
- For how long will this data be available start date provided 20-11-2024 and end date provided 20-12-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title A Randomized Control Clinical Trial to evaluate the efficacy of Gokshurkadi churna in the management of mutrashmari. Null hypothesis H0 Gokshurkadi churna is not significantly effective in the management of mutrashmari Alternate Hypothesis H1 Gokshurkadi churna is significantly effective in the management of mutrashmari Study Design Simple Randomized Control Clinical Trial Sample size-60 Group A Gokshurkadi churna Group B pashanbhed churna Total Duration of the Study 21 days Mode of administration Oral route Follow up 1st 7th 14th 21st day Assessment criteria Objective - size and site of calculus Subjective - pain, burning micturition, hematuria Results will be drawn as per assessment criteria and statistical analysis
|