| CTRI Number |
CTRI/2025/04/084579 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
10/04/2025 |
| 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 Efficacy Of Sharadipanchmuladdya Ghrut In Mutrashmari With Special Reference To Urolithiasis |
|
Scientific Title of Study
|
Randomised Controlled Clinical Study To Evaluate The Efficacy Of Sharadipanchmuladdya Ghrut In Mutrashmari With Special Reference To Urolithiasis |
| Trial Acronym |
no |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhilasha Shrishail Parit |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Sangli |
| Address |
Shalyatantra OPD Of LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9309823311 |
| Fax |
|
| Email |
abhilashaparit1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangini Suresh Nagaralmath |
| Designation |
Associate Professor |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
| Address |
Shalyatantra OPD Of LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
7709677061 |
| Fax |
|
| Email |
shubhasn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhilasha Shrishail Parit |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
| Address |
Shalyatantra OPD Of LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9309823311 |
| Fax |
|
| Email |
abhilashaparit1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Sangli Maharashtra 415409 INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Abhilasha Shrishail Parit |
| Address |
Shalyatantra OPD Of LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Sangli Maharashtra 415409 |
| 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 Abhilasha Shrishail Parit |
LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur |
Shalyatantra OPD Of LRP Ayurvedic Medical College And Hospital PG Institute And Research Centre Urun Islampur Sangli Maharashtra 415409
Sangli
MAHARASHTRA |
9309823311
abhilashaparit1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N23||Unspecified renal colic. Ayurveda Condition: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trikantak Ghrut, Reference: R.Vidyanath,Co-Author-K.Nishteswar Sahastrayog Samhita.Ghrutprakaran Adhyay 2,Trikantak Ghrut 22 ,Page no.77., Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sharadipanchmuladdya Ghrut, Reference: Bhavprakash Samhita Part 2 Choukhambha Sanskrit Prakashan ,8 Adhyay ,Shlok 82,Pg No. 390, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Sharkara), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient with clinical features and USG showing Mutrashmari of size upto 10mm will be taken for treatment.
2)The patient will be selected irrespective of gender, religion, occupation,marital status.
3)Patients of the age in between 20-60 years.
4)Patients with known case of mutrashmari
5)Grade 1 hydronephrosis
|
|
| ExclusionCriteria |
| Details |
1)Patient with bleeding disorders – Immunoglobulin A,drug induced haematuria etc.
2)Malignant Disorders -Urethral malignancy or any suspected malignancy
3)Patients associated with disorders like Gout, Hyperthyroidism, Parathyroidism.
4)Patients with Immunocompromised disorders -Human immunodeficiency virus, Hepatitis B Surface Antigen, sexually transmitted disease
5)Case which required any other surgical intervention
6)Patient with mutrashmari with other urinary disorders like Chronic Urine retention, Pyelonephritis, BPH, glomerulonephritis, Nephropathy, Renal failure
7)Pregnant and lactating women
8)Patients with k/c/o hypertension and Diabetes Mellitus.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Sharadipanchmuladdya ghrut in Mutrashmari with special reference to Urolithiasis. |
at 1st week,2nd week and on 3rd week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study in detail the literature about mutrashmari according to ayurvedic aspect.
2.To study urolithiasis in details according to modern aspect.
3.To Preparation of sharadipanchmuladdya ghrut.
4.To compare Sharadipanchmuladdya ghrut with Trikantak ghrut.
|
at 1st week, 2nd week & 3rd week |
|
|
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)
|
21/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Ayurveda has number of preparations, herbs and kalpas that are useful in management. Sharadipanchmuladdya ghrut is also one of them which is available affordable, and easy to administrate. The aim of my study is Evaluation of the Efficacy of Sharadipanchmuladdya Ghrut in Mutrashmari with Special Reference to Urolithiasis. This research investigates the efficacy of Sharadipanchmuladdya Ghrut, a traditional Ayurvedic formulation, in the treatment of Mutrashmari (urolithiasis). Urolithiasis, characterized by the formation of urinary stones, is a prevalent condition that can cause severe discomfort and complications.The study involved a sample size of 70 patients, all diagnosed with urolithiasis, to evaluate the therapeutic effects of Sharadipanchmuladdya Ghrut in alleviating symptoms, reducing stone size, and improving overall renal function. Patients were divided into treatment and control groups, with the treatment group receiving Sharadipanchmuladdya Ghrut for a specified duration. |