| CTRI Number |
CTRI/2020/12/029593 [Registered on: 04/12/2020] Trial Registered Prospectively |
| Last Modified On: |
03/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A STUDY OF ASHMARIHAR KWATH AND GOKSHURADI GUGGLU IN KIDNEY STONES |
|
Scientific Title of Study
|
A COMPARATIVE STUDY ON THE EFFECT OF ASHMARIHAR KWATH AND GOKSHURADI GUGGLU IN ASHMARI(UROLITHIASIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prabhat kumar gupta |
| Designation |
p.g. scholar |
| Affiliation |
Patanjali bhartiya ayurvigyan sansthan |
| Address |
Room no. 6008 building no. 6 hostel patanjali phase 2 patanjali yogpeeth haridwar
Patanjali ayurvigyan evam sansthan room no. 15 surgey department phase 1 patanjali yogpeeth haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7991472293 |
| Fax |
|
| Email |
gprabhat235@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drsaurabh sharma |
| Designation |
professor |
| Affiliation |
Patanjali bhartiya ayurvigyan sansthan |
| Address |
OPD NO.15 Patanjali ayurveda hospital Haridwar
Patanjali ayurvigyan sansthan room no. 15 phase 1 patanjali yogpeeth haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9412116176 |
| Fax |
|
| Email |
surgeonsaurabh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prabhat kumar gupta |
| Designation |
p.g. scholar |
| Affiliation |
Patanjali bhartiya ayurvigyan sansthan |
| Address |
Room no. 6008 patanjali phase 2 patanjali yogpeeth haridwar
Patanjali ayurvigyan sansthan room no. 15 phase 1 patanjali yogpeeth haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7991472293 |
| Fax |
|
| Email |
gprabhat235@gmail.com |
|
|
Source of Monetary or Material Support
|
| patanjali bhartiya ayurvigyan evum anusandhan sansthan |
|
|
Primary Sponsor
|
| Name |
Patanjali bhartiya ayurvugyan evam anushandhan sansthan |
| Address |
Patanjali phase 1 bahadarabad haridwar uttrakhand |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| prabhat kumar gupta |
Patanjali ayurveda hospital |
OPD no 15 dept.of shalya tantra Patanjali ayurved hospital patanjali bhartiya ayurvigyan evum anusandhan sansthan
Hardwar
UTTARANCHAL |
7991472293
gprabhat235@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Patanjali Bhartiya ayurvigyan evum anusadhan sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ASHMARIHAR KWATH |
ASHMARIHAR KWATH IS TAKEN ORALLY LIQUID INTAKE (ABHYANTARPAN)BEFORE MEAL FOR 3 MONTHS |
| Intervention |
GOKSHURADI GUGGLU |
IT IS TAKEN AS ORALLY 2 TAB BD AFTER MEAL FOR 3 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1-Patients having sign and symptoms of ashmari is included that is pain in the region of umbilicus, perineum and dome of the bladder experience of severe pain.
2-pt. having renal calculi/ureter/bladder calculi and complaints of dribbling or burning micturition |
|
| ExclusionCriteria |
| Details |
1- complications related to kidney / ureter/ bladder like ARF CRF,PKD.IRF
2-the pt.of ashmari havng systemic disease like, IHD,RHD,AIDS TB
3-Pt having severe moderate or severe hydro-uretronephrosis will be excludede
4-Pt. will drop if they show any complications |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameter-
1- pain for visual analouge scale 8-7
2-Burning micturition grade 3-2
3-Haematuria grade 3
4-Frequency of micturition grade 3 (in 24 hours)
Objective parameter-
1-size of the calculus
2- site of the calculus
3-number of stones
4-hydro-uretronephrosis |
3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
subjective parameter
1-pain visual analogue sacle 1-2
2-burning micturition grade 1
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/12/2020 |
| 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
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
IN THIS TRIAL WE ARE SELECTING THE PATIENTS OF ASHMARI IN WHICH WE VWILL DO THE INTERVENTION IN TWO GROUPS (30 PATIENTS IN EACH GROUP).IN ONE GROUP WE WILL INTERVENE WITH AYURVEDIC MEDICINE OF ASHMARHAR KWATH ION 7 DAYS,WHERE WE WILL INTERVEN WITH GOKSHURADI GUGGLU GOKSHURADI GUGGLU FOR 7 DAYS AND ALSO FOR ORAL INTAKE FOR 60 DAYS.ASSESEMENT SHUOLD BE DONE ON THE BASIS OF INVESTIGATION DONE DURING PRE-TREATMENT AND POST TREATMENT AS DISCUSSED EARLIER |