| CTRI Number |
CTRI/2025/06/088707 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
07/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to see the added effect of Trunapanchmuladighrita and Gokshurachurna in treating mootrashmari |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial of Add on effect of Trunapanchmuladighrita with Gokshurachurna 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 |
Dr Akshay Haribhau Devarkar |
| Designation |
PG scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath charitable Ayurvedic Hospital |
| Address |
Tilak Ayurveda Mahavidyalaya ,Department of Shalyatantra 2nd floor, 583/2,Rastapeth,Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8698072410 |
| Fax |
|
| Email |
devarkarakshay81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanraj Gaikwad |
| Designation |
Assistant Professor Department of Shalyatantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath charitable Ayurvedic Hospital |
| Address |
Tilak Ayurveda Mahavidyalaya ,Department of Shalyatantra ,2nd floor ,583/2,Rastapeth,Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9422342048 |
| Fax |
|
| Email |
draj.gaikwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Haribhau Devarkar |
| Designation |
PG scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath charitable Ayurvedic Hospital |
| Address |
Tilak Ayurveda Mahavidyalaya ,Department of Shalyatantra 2nd floor 583/2,Rastapeth,Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8698072410 |
| Fax |
|
| Email |
devarkarakshay81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital, Rastapeth , Pune 411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Rastapeth Peth , Pune ,411011 |
| 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 Akshay Haribhau Devarkar |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
OPD no.7 Department of Shalyatantra,Rastapeth,pune
Pune
MAHARASHTRA |
8698072410
devarkarakshay81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath charitable Ayurvedic Hospital , institutional 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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gokshurachurna , Reference: Sushruta Samhita chikitsasthna7/20 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trunapanchmuladi ghrita, Reference: Chakradatta 39, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Size of calculus-A known diagnosed case of Non obstructive ureteric calculus 4 to 7 mm.
2. Age group -18 to 60 years with irrespective of gender |
|
| ExclusionCriteria |
| Details |
1. Participants who are suffering from severe systemic disorders like renal failure, Carcinoma Known case of DM, HTN, Asthma, HIV, HbsAg
2.Congenital anomalies of kidney.
3.The pregnant women |
|
|
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 |
| Efficacy of Trunapanchmuladi ghrita with Gokshura churna in managing Mootrashmari, assessed by reduction in symptom severity scores and overall treatment response. |
1st follow up after 7 days and then 14 days and 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in Calculus Size and Expulsion:
Change in size of urinary calculi (measured via imaging techniques like ultrasound or CT).
Rate of spontaneous expulsion of calculi during or after treatment.
2. Symptom Improvement:
Reduction in individual symptoms such as:
Abdominal pain
Burning micturition
Hematuria
Measured using standardized symptom scoring or patient-reported outcomes.
3. Adverse Drug Reactions (ADR):
Incidence and severity of any adverse drug reactions observed during the treatment period. |
18 points |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
18/06/2025 |
| 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
|
Objective
To evaluate the efficacy of Trunapanchmuladi Ghrita combined with Gokshura Churna versus Gokshura Churna alone in treating Mootrashmari (urinary stones).
Study Design
Open, randomized controlled clinical trial
Duration 28 days
Sample size: 64 participants 32 per group
Participants:
Adults aged 18–60 with non-obstructive ureteric calculi (4–7 mm)
Exclusions include systemic illnesses, pregnancy, and congenital kidney anomalies
Interventions:
Group A: Trunapanchmuladi Ghrita + Gokshura Churna
Group B: Gokshura Churna alone
Both groups advised pathya-apathya and hydration
Assessment Parameters:
Subjective: Pain, burning micturition, hematuria
Objective: Size, site, and number of stones via USG
Statistical analysis: Wilcoxon Signed Rank Test, Unpaired t-test
Rationale:
Ayurveda offers promising and cost-effective alternatives to conventional treatments for kidney stones, which often recur after modern interventions.
Expected Outcome:
To determine whether the add-on therapy provides statistically and clinically significant improvement in symptom relief and stone reduction. |