CTRI Number |
CTRI/2022/05/042728 [Registered on: 23/05/2022] Trial Registered Prospectively |
Last Modified On: |
20/05/2022 |
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
|
To study the efficacy of Agnimantha Beej Choorna (Agnimantha powder) with Takra Anupana in Mutrashmari Pidam (Pain management in urolithiasis) |
Scientific Title of Study
|
Randomised control clinical study of efficacy of Agnimanth Beej Choorna with Takra Anupan in management of Mutrashmari Pidam w.s.r. to Urolithiasis pain |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Machhindra Bhagvan Gorad |
Designation |
PG Scholar Shalyatantra |
Affiliation |
Hon. Shri. Annasaheb Dange Ayurvedic Medical College ,Ashta, tal.Walva,Dist.Sangli pin code-416301 |
Address |
Hon. Shri. Annasaheb Dange Ayurvedic Medical College,Ashta,tal.
Walva,Dist.Sangli
Department of Shalyatantra
OPD NO.2
Hon. Shri. Annasaheb Dange Ayurvedic Medical College,Ashta,tal.
Walva,Dist.Sangli
Department of Shalyatantra
OPD NO.2 Sangli MAHARASHTRA 416301 India |
Phone |
9767399711 |
Fax |
|
Email |
drmbgorad1@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Manoj Vilas Patil |
Designation |
Professor |
Affiliation |
Hon. Shri. Annasaheb Dange Ayurvedic Medical College pin code 416301 |
Address |
Hon. Shri. Annasaheb Dange Ayurvedic Medical College,Ashta,tal. Walva,Dist.Sangli
Department of Shalyatantra
OPD NO 2
OPD NO - 2
Opd no 2. Hon. Shri. Annasaheb Dange Ayurvedic Medical College,Ashta,tal. Walva,Dist.Sangli
Department of Shalyatantra
OPD NO.2
OPD NO 2
Opd no 2. Sangli MAHARASHTRA 416301 India |
Phone |
9422613195 |
Fax |
|
Email |
dr.patilmanoj77@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Manoj Vilas Patil |
Designation |
Professor |
Affiliation |
Hon. Shri. Annasaheb Dange Ayurvedic Medical College astha pin code 4163301 |
Address |
Hon. Shri. Annasaheb Dange Ayurvedic Medical College,Ashta,tal. Walva,Dist.Sangli
Shalyatantra Department
OPD NO.2 Hon. Shri. Annasaheb Dange Ayurvedic Medical College,Ashta,tal. Walva,Dist.Sangli
Shalyatantra Department
OPD NO.2 Sangli MAHARASHTRA 416301 India |
Phone |
9422613195 |
Fax |
|
Email |
dr.patilmanoj77@gmail.com |
|
Source of Monetary or Material Support
|
Annasaheb dange Ayurved medical college ashta |
|
Primary Sponsor
|
Name |
Hon Annasaheb Dange Ayurvedic Medical College and post graduation research center Ashta |
Address |
Vidyanagar,Ashta,Tal. Walva,Dist. Sangli |
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 |
Dr Manoj patil |
Dhanvantari Ayurved hospital Astha, tal Walwa Dist Sangli pin code 416301 |
Department of Shalyatantra
OPD NO.2 Sangli MAHARASHTRA |
9422613195
dr.patilmanoj77@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee |
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: Mutrashmari, (2) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: Mutrashmari Pidam , |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mefenamic acid , Reference: K. D. Tripathi Pharmacology Book, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Agnimantha Beeja Churna , Reference: Vangsen samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
15.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patient aged between 15 to 60 years will be selected irrespective of sex,prakruti,occupation,race,chronicity,socioeconomic status. |
|
ExclusionCriteria |
Details |
1)K/C/O Malignancy of urinary tract
2)STD,HIV Infection
3)Uncontrolled DM
4)Pyelonephritis |
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Agnimantha Beeja Churna with Takra is effective in Mutrashmari Pidam ( Pain management). Pain will be assessed by VAS scale. |
1 week.
Primary out come will be 1 week for both groups. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Mefenamic acid is effective in Mutrashmari Pidam ( Pain management). Pain will be assessed by VAS scale. |
2 week |
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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)
|
30/05/2022 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
30/05/2022 |
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
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
This study will evaluate the efficacy of Agnimanth Beej Choorna in Mutrashmari Pidam. During this trial trying to evaluate the untoward effect of Agnimanth Beej Choorna in Mutrashmari as their is no previous work done on Agnimanth beej Choorna so emphasis will be made to find out easy cost effective method to control Mutrashmari Pidam with no side effects. |