| 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)] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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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
|
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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. |