| CTRI Number |
CTRI/2019/02/017661 [Registered on: 14/02/2019] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
management of ano rectal piles with kshara |
|
Scientific Title of Study
|
A Comparative Clinical Study of Arka And Apamarga Pratisaraneeya Kshara In The Management of Arsha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratik Kumar Keshari |
| Designation |
PG student |
| Affiliation |
parul institute of ayurveda |
| Address |
opd no 116, shalya department, parul ayurved hospital, parul university, vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9451709655 |
| Fax |
|
| Email |
pratikkeshari08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivekanand Kullolli |
| Designation |
professor |
| Affiliation |
parul institute of ayurveda |
| Address |
opd no 116, shalya department, parul ayurved hospital, parul university, vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9945079276 |
| Fax |
|
| Email |
vivekkullolli@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratik Kumar Keshari |
| Designation |
PG student |
| Affiliation |
parul institute of ayurveda |
| Address |
opd no 116, shalya department, parul ayurved hospital, parul university, vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9451709655 |
| Fax |
|
| Email |
pratikkeshari08@gmail.com |
|
|
Source of Monetary or Material Support
|
| parul institute of ayurveda, Vadodara, Gujrat |
|
|
Primary Sponsor
|
| Name |
Department of Shalya Tantra |
| Address |
parul institute of ayurveda, Vadodara, Gujrat |
| 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 |
| pratik kumar |
parul ayurveda hospital |
opd no 116, parul ayurveda hospital, parul university
Vadodara
GUJARAT |
9451709655
pratikkeshari08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K641||Second degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
apamarga pratisaraneeya kshara |
the whole plant of apamarga (achyranthes aspera linn.)are burnt, the ash is collected and added water and reduced by heating and sankh nabhi, etc were mixed and final form of drug was obtained. |
| Intervention |
arka pratisaraneeya kshara |
the whole plant of arka (calotropis procera)are burnt, the ash is collected and added water and reduced by heating and sankh nabhi, etc were mixed and final form of drug was obtained. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.diagnosed cases of raktaja, pittaja and raktajpittaja arsha
2. 1 and 2 degree haemorrhoids
|
|
| ExclusionCriteria |
| Details |
1. vataja and kaphaja arsha
2. ayogya for kshara prayoga
3. pregnancy, hiv etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in size of pile mass |
on 1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in size of pile mass |
1 month |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2019 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
hypothesis;- arka pratisaraneeya kshara is effective in the management of arsha. |