| CTRI Number |
CTRI/2024/11/076336 [Registered on: 06/11/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Shigru Kwatha and Gokshuradi Guggulu in Mutrashmari (Urolithiasis) |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Shigru Kwatha and Gokshuradi Guggulu in Mutrashmari(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 |
Shubham Gaur |
| Designation |
Pg scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15, Department of Shalya-Tantra, Patanjali ayurved
hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,
Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405
India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8954720047 |
| Fax |
|
| Email |
drshubhamgaur123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Sharma |
| Designation |
Associate Pofessor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15, Department of Shalya-Tantra, Patanjali ayurved
hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,
Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7020108714 |
| Fax |
|
| Email |
surgeonsaurabh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubham Gaur |
| Designation |
Pg scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15, Department of Shalya-Tantra, Patanjali ayurved
hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,
Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405
India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8954720047 |
| Fax |
|
| Email |
drshubhamgaur123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Yogpeeth phase- 1, Roorkee Road,Haridwar,
India - 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan ,Haridwar,Uttarakhand ,India 249405 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Shubham Gaur |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
OPD 15, Department of Shalya-Tantra, Patanjali ayurved
hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,
Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL |
8954720047
drshubhamgaur123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
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: ASMARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shigru Kwatha, Reference: Brihat Nighantu Ratnakar Ashmarirogakarmavipaak pancham bhaag, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Anushnsheet jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Goshuradi Guggulu, Reference: Madhav nidan madhyam khand, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -anushnasheet jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients willing to undergo trial and ready to give informed and written consent.
b) Patients of both sexes, irrespective of religion, socioeconomic status occupation will be taken.
d) Radiological evidence of (upto 15 mm) in kidney, ureter, urinary bladder & urethra.
e) Classical symptoms of Ashmari. |
|
| ExclusionCriteria |
| Details |
a) Patients does not willing to undergo trial and ready to give informed and
written consent.
b) Complications related to Kidneys/ Ureter / Bladder like - Acute Renal
Failure, Chronic Renal Failure, Polycystic Kidney diseases, Impaired Renal
function, etc.
(c) Patients of Ashmari having systemic diseases like RHD ,AIDS
(Acquired immune deficiency syndrome).Other chronic diseases like TB (Tuberculosis), Hepatitis etc. will be
excluded.
d) Pregnant women and lactating mothers will be excluded.
e) Patients will be dropped if they develop any complications during the course
will also be excluded.
f) Calculi size more than 15 mm.
g) Patients having Moderate or severe Hydronephrosis will be excluded. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
A) Subjective parameters: -
a) Pain
b) Burning micturition
c) Dysuria
d) Frequency of micturition
e) Hematuria |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
B) OBJECTIVE PARAMETERS:
a)Number of calculi
b)Size of calculus (according to USG before and after treatment).
c)Site of calculus |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
09/11/2024 |
| Date of Study Completion (India) |
15/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 study is a comparative clinical evaluation of Shigru Kwatha and Gokshuradi Guggulu in Murtrashmari (Urolithiasis).This will be conducted on 60 randomly selected patients from OPD/IPD of Shalya Tantra Department of Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar. Patients will be divided into two groups- 30 patients will be administered with Shigru Kwatha orally and 30 patients will be administered with Gokshuadi Guggulu orally. First follow up will be after 30 days of treatment and second follow up will be after 60 days of treatment and third follow up after 90 days of treatment.Assesment will be done on the basis ofsubjective and objective parameters as discussed earlier. |