| CTRI Number |
CTRI/2025/03/082458 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Ayurvedic medicine in Renal calculus. |
|
Scientific Title of Study
|
Randomized Controlled Trial To Study The Efficacy of
Madhu Mishrit Gokshurbeej Churna In The Management of
Mutrashmari with Special Reference To Renal Calculus. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Supriya Ashok Lende |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurved mahavidyalay, Sangamner |
| Address |
OPD number 6, Shalyatantra Department, Siddhakala Ayurved Mahavidyalaya, Pimparne road, Sangamner, Ahmadnagar, Maharashtra, 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8879716448 |
| Fax |
|
| Email |
slende96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naimish Kishor Saraf |
| Designation |
Head of Department of Shalyatantra |
| Affiliation |
Siddhakala Ayurved mahavidyalay, Sangamner |
| Address |
Shalyatantra Department, Siddhakala Ayurved Mahavidyalaya, Pimparne road, Sangamner, Ahmadnagar, Maharashtra, 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9766786123 |
| Fax |
|
| Email |
naimishsaraf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naimish Kishor Saraf |
| Designation |
Head of Department of Shalyatantra |
| Affiliation |
Siddhakala Ayurved mahavidyalay, Sangamner |
| Address |
Shalyatantra Department, Siddhakala Ayurved Mahavidyalaya, Pimparne road, Sangamner, Ahmadnagar, Maharashtra, 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9766786123 |
| Fax |
|
| Email |
naimishsaraf@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurved Mahavidyalaya, Pimparne road , Sangamner khurd, Sangamner ,
Ahilyanagar , Maharashtra , India. Pincode- 422605. |
|
|
Primary Sponsor
|
| Name |
Supriya Ashok Lende |
| Address |
Siddhakala Ayurved Mahavidyalaya, Pimparne road , Sangamner khurd, Sangamner , Ahilyanagar , Maharashtra , India. Pincode- 422605. |
| 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 Supriya Ashok Lende |
Siddhakala Ayurved mahavidyalay, Sangamner |
Shalyatantra OPD number 6, Ground floor, Siddhakala Ayurved mahavidyalay, Pimparne road, Sangamner 422605 Ahamadnagar
Ahmadnagar
MAHARASHTRA |
8879716448
slende96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of Ayurved Research and Statistics Committee of Siddhakala Ayurved Mahavidyalaya, Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N23||Unspecified renal colic. Ayurveda Condition: MUTRAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madhu Mishrit Gokshurbeej Churna, Reference: Bhaishajya Ratnavali Samhita, Chapter number 36, Shloka 17, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Ajaksheer), Additional Information: Aushad sevan kala- vyaanudaan kala | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pashanbhed Churna, Reference: Bhavaprakash Samhita, Chapter 2, Shloka number 184-185, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: Aushad sevan kala- vyaanudaan kala |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age of patients above 18 years and below 60 years.
Patients are accepted irrespective of sex, occupation, religion and socio-economic status.
Patients presented with Samanya Lakshanas of Mutrashmari as
per the classics – Pain at renal angle, Painful and frequency
micturition, Burning micturition, Vomiting, Nausea.
Radiological evidence of calculus up to 6mm without any residual complications.
Calculus present in any location of urinary tract.
Patients who give informed consent and are willing to undergo
treatment.
Patients who follow proper protocols should be included. |
|
| ExclusionCriteria |
| Details |
Patients of known case of malignancy/ carcinoma of urinary tract.
Patients having Mutrashmari associated with
1)Diabetes mellitus
2)Acute renal failure
3)Chronic renal failure
4)Obstructive uropathy
5)Congenital abnormalities of urinary system
6)Prostatomegaly
Immunocompromised Patients.
Patients who are not giving written consent are excluded.
Patients who withdraws treatment by themselves in between.
Patients who are not willing for treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to evaluate the efficacy of Madhu Mishrit Gokshurbeej Churna with Ajaksheer in managing Mutrashmari (renal calculus) by assessing reduction in stone size and number (via USG), symptom relief (pain, burning micturition, nausea, vomiting, and tenderness), and changes in calculus location over a 7-day treatment period. |
Day 0, 3 and 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes
1.Effect of Gokshurbeej Churna on Ashmaribhedan (stone breaking) & Mutral (diuretic) action assessed via changes in urinary output, frequency of urination & relief in urinary obstruction.
2.Comparison of symptomatic relief between trial (Madhu Mishrit Gokshurbeej Churna) & control (Pashanbhed Churna) groups measured using pain scores, burning micturition, & tenderness reduction.
3. Longitudinal assessment of renal calculus recurrence evaluated over followup visits beyond the 7 day treatment period.
Assessment Timeline Day 0, Day 3, Day 7 Symptomatic relief & USG findings. |
Day 0, 3 & 7 |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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 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
|
This randomized, open-label controlled clinical trial aims to compare the safety and efficacy of Madhumishrit Gokshurbeej Churna (3 grams) with Pashanbhed Churna (3 grams) over a 7-day period in 80 patients diagnosed with Mutrashmari (renal calculus). The primary objectives are to assess stone reduction, symptom relief, and stone passage, seeking a natural and cost-effective treatment alternative.
|