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CTRI Number  CTRI/2021/01/030583 [Registered on: 19/01/2021] Trial Registered Prospectively
Last Modified On: 18/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study of Yava kshara along with Nagaradi kashaya in the management of Mutrashmari (Urolithiasis). 
Scientific Title of Study   “A CLINICAL EVALUATION OF YAVA KSHARA ALONG WITH NAGARADI KASHAYA IN THE MANAGEMENT OF MUTRASHMARI W.S.R. TO UROLITHIASIS” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR DEVESHWAR PRASAD 
Designation  MS SCHOLAR 
Affiliation  SHREE NARAYAN PRASAD AWASTHI GOVERNMENT AYURVED COLLEGE RAIPUR CHHATTISGARH  
Address  DEPTT OF SHALYA TANTRA SHREE NARAYAN PRASAD AWASTHI GOVERNMENT AYURVED COLLEGE RAIPUR CHHATTISGARH 492010 INDIA

Raipur
CHHATTISGARH
492010
India 
Phone  8109642085  
Fax    
Email  Bhardwajdeveshwar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Balendra Singh 
Designation  Reader  
Affiliation  SHREE NARAYAN PRASAD AWASTHI GOVERNMENT AYURVED COLLEGE RAIPUR CHHATTISGARH 
Address  DEPTT OF SHALYA TANTRA SHREE NARAYAN PRASAD AWASTHI GOVERNMENT AYURVED COLLEGE RAIPUR CHHATTISGARH 492010 INDIA

Raipur
CHHATTISGARH
492010
India 
Phone  9039180335  
Fax    
Email  drbalendrasingh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Uttam kumar Nirmalkar 
Designation  Lecturer 
Affiliation  SHREE NARAYAN PRASAD AWASTHI GOVERNMENT AYURVED COLLEGE RAIPUR CHHATTISGARH 492010 INDIA 
Address  DEPTT OF SHALYA TANTRA SHREE NARAYAN PRASAD AWASTHI GOVERNMENT AYURVED COLLEGE RAIPUR CHHATTISGARH 492010 INDIA

Raipur
CHHATTISGARH
492010
India 
Phone  8234057199  
Fax    
Email  druk01508@gmail.com  
 
Source of Monetary or Material Support  
SHRI NARAYAN PRASAD AWASTHI GOVERNMENT AYURVED COLLEGE RAIPUR CHHATTISGARH INDIA 
 
Primary Sponsor  
Name  SHRI NARAYAN PRASAD AWASTHI GOVERNMENT AYURVED COLLEGE RAIPUR CHHATTISGARH INDIA 
Address  SHRI NARAYAN PRASAD AWASTHI GOVERNMENT AYURVED COLLEGE RAIPUR 492010 CHHATTISGARH INDIA 
Type of Sponsor  Other [Govt. Ayurvedic College Raipur (CG)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR DEVESHWAR PRASAD  SHRI KHUDADAD DOONGA JI GOVT AYURVED HOSPITAL RAIPUR  OPD NO 15 DEPT OF SHALYA TANTRA SHRI KHUDADAD DOONGA JI GOVT AYURVED HOSPITAL RAIPUR CHHATTISGARH
Raipur
CHHATTISGARH 
8109642085

Bhardwajdeveshwar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N200||Calculus of kidney. Ayurveda Condition: ASHMARI,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nagaradi kashaya along with Yava kshara  Nagaradi kashaya dose 20 ml BD in a day and Yava kshara dose 500mg BD in a day, drugs administration route - orally, duration of 6 weeks 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age Group 18-60 Years.
2.All types of Prakriti.
3.Patients with the size of Calculi less than 8 mm.
4.Sex both male & female.
5.Evidence of Urolithiasis as per modern imaging techniques.
 
 
ExclusionCriteria 
Details  1.Pregnancy/ Lactating mother.
2.HIV, HBsAg infection.
3.Pyelonephritis.
4.Hydronephrosis.
5.Stag horn renal stone.
6.Any acute urinary obstructive conditions.
7.Uncontrolled diabetes mellitus, Hypertension, Thyroid dysfunction.
8.Severe hepatic disease.
9.Auto immune disease.
10.Patients required urgent surgical intervention.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease the renal calculi of size, their symptioms are less and pts.are comfortable.  6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
pts many symptoms are disappear and pts are happy  6 weeks 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/01/2021 
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="0"
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  

Ayurveda is the science of life, Susruta Samhita is the most ancient  textbook. The Mutrashmari is considered as one of the most distressing disease among the urinary disorders. Occuring of Mutrashmari  are shooting up day to day due to sedentary lifestyle, Intake fast food, Lack of exercise and Hectic schedule leads to many urological problems, The Mutrashmari (Urolithiasis) is one of them, formed in uninary tract. In Ayurveda mentioned about Mutrashmari which means Calculi or Stone and its small pieces are known as Sharkara, or Sikata i.e. gravels Stone like structure is called  Mutrashmari.

                    In person who does not undergo purification regularly and who indulge in taking unhealthy foods and activities thats why kapha gets aggravated and combines with urine, reaches to the  urinary bladder and staying there and then produces Mutrashmari. My trial medicine YAVA KSHARA  ALONG WITH NAGARADI KASHAYA also used in Mutrashmari (Urolithiasis). Nagaradi kashaya dose 20 ml BD & Yava kshara 500 mg BD.

·    Yava Kshara along with Nagaradi Kashaya oral administration, Duration of study -  6 Week , Follow up -  In 15 Days upto next 2 months.

Yava Kshara along with Nagaradi Kashaya drugs properties of lekhan, bhedan, anuloman, mutral & krimighna,  Easy available of drugs & cost effective therapy, Modern physician mostly advise surgery for Mutrashmari, After surgery  patients facing many complications. So patients  looking toward Ayurveda for solution of Mutrashmari.

 
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