| CTRI Number |
CTRI/2025/03/082881 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Kidney stone Relief - A study of Trunapanchmuladi Ghrut in 80 adults (15-60 years). |
|
Scientific Title of Study
|
A randomised clinical controlled study to evaluate the efficacy of Trunpanchmuladi Ghrita in the management of Mutrashmari W.S.R. 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 |
Dr Prajot Kokane |
| Designation |
MS Shalyatantra Scholar |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
OPD No 18 Department of Shalyatantra Dr VJD Gramin Ayurved Mahavidyalaya near renuka mata mandir Patur Dist Akola 444501 Maharashtra India
Akola
MAHARASHTRA
444501
India |
| Phone |
7775019886 |
| Fax |
|
| Email |
prajotkokane2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Belorkar |
| Designation |
MS Shalyatantra Associate Professor |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
OPD No 18 Department of Shalyatantra Dr VJD Gramin Ayurved Mahavidyalaya near renuka mata mandir Patur Dist Akola 444501 Maharashtra India
Akola
MAHARASHTRA
444501
India |
| Phone |
7972681655 |
| Fax |
|
| Email |
ganeshbelorkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganesh Belorkar |
| Designation |
MS Shalyatantra Associate Professor |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
OPD No 18 Department of Shalyatantra Dr VJD Gramin Ayurved Mahavidyalaya near renuka mata mandir Patur Dist Akola 444501 Maharashtra India
MAHARASHTRA
444501
India |
| Phone |
7972681655 |
| Fax |
|
| Email |
ganeshbelorkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalyatantra
Dr VJD Gramin Ayurved Mahavidyalaya near Renuka Mata Mandir Patur Dist Akola
444501
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Dr VJD Gramin Ayurved Mahavidyalaya |
| Address |
Dr VJD Gramin Ayurved Mahavidyalaya near Renuka Mata Mandir Patur Dist Akola
444501
Maharashtra
India |
| 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 Prajot Kokane |
Dr. VJD Gramin Ayurved Mahavidyalaya |
OPD No 18 Department of Shalyatantra
Dr VJD Gramin Ayurved Mahavidyalaya near Renuka Mata Mandir Patur Dist Akola
444501
Maharashtra
India
Akola
MAHARASHTRA |
7775019886
prajotkokane2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr VJD Gramin Ayurved Mahavidyalaya, Patur, Akola |
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 | Comparator Arm (Non Ayurveda) | | - | Tab Neeri | 2 Tablets twice a day after food for 28 days. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trunapanchamuladi Ghrit, Reference: Bhavprakash 37/82, Route: Oral, Dosage Form: Ghrita, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients showing classical signs and symptoms of Mutrashmari i.e. Renal –
ureteric-vesicular calculi as described in Ayurvedic Samhita.
2) Calculi measuring below 10 mm.
3) Patient age between 15-60 yrs .
15
4) Patients from all socio-economic status.
5) Either gender |
|
| ExclusionCriteria |
| Details |
1) Patients who are not willing.
2) Patients with impending renal failure.
3) Pregnant and lactating women.
4) Patients having age less than 15 years and more than 60 years.
5) Patients having the stone size more than 10 mm in diameter.
6) Staghorn calculus.
7) Severe haematuria.
8) Patients with Diabetes Mellitus, HIV, Hepatitis, TB.
9) Patients with immediate surgical requirement and complications. |
|
|
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 |
Decrease in symptoms like
1) Pain at renal angle
2) Burning micturition
3) Radiating pain loin to groin
4) Dysuria of Mutrashmari with reference to Urolithiasis |
7 days, 14 days, 21 days and 28 days after starting treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of Mutrashmari |
18 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/04/2025 |
| 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="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
|
Urolithiasis, commonly known as kidney stones, represent a significant
urological health burden globally. These calculi form within the renal system due to
the precipitation of substances such as calcium, oxalate, uric acid, and phosphate.
The incidence of renal calculi has been steadily rising in recent decades, affecting
individuals of all ages and genders, with a notable increase observed in younger
populations. Mutrashmari, as described in Ayurveda, corresponds to renal calculi in
modern medical terminology. Ayurveda, offers a holistic approach to healthcare,
emphasizing the balance between mind, body, and spirit. The management of
Mutrashmari in Ayurveda involves various herbal formulations and lifestyle
modifications aimed at not only dissolving the stones but also preventing their
recurrence and addressing associated symptoms such as pain and discomfort. Trunapanchmuladi Ghrit is one such formulation prescribed in Ayurvedic texts
for the management of Mutrashmari. It is a medicated ghee prepared using a
combination of Kusha, Kasha, Shar, Darbh, Ikshu and Gokshur. Each chosen for its
supported therapeutic properties in Ayurveda. These herbs are traditionally believed
to possess litholytic (stone-dissolving), diuretic, and anti-inflammatory effects, which
are crucial for the treatment of renal calculi and associated urinary tract symptoms. |