| CTRI Number |
CTRI/2018/02/012178 [Registered on: 27/02/2018] Trial Registered Prospectively |
| Last Modified On: |
26/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
internal piles (1st ,2nd and 3rd degree) treatment by palash kshara application and kankayan vatak. |
|
Scientific Title of Study
|
Effect of Palashkshara Application With And Without Kankayan Vatak In The Management Of Rakatjaarsha (1 st 2 nd and 3 rd Degree Hemorrhoids ) An Open Labelled Randomized Comparative Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nilima Gamit |
| Designation |
MS 2 nd Year |
| Affiliation |
Institute for Post Graduate Training And Research Centre |
| Address |
OPD 01 6th floor Department of Shalya Tantra IPGT and RA GAU Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9409186162 |
| Fax |
|
| Email |
gamitnilima222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmi Priya Dei |
| Designation |
Professor And HOD |
| Affiliation |
Institute for Post Graduate Training And Research Centre |
| Address |
OPD 12 5th floor Department of Prasuti Tantra And Stree Roga IPGT and RA GAU Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
7874982753 |
| Fax |
|
| Email |
deilaxmipriya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi Priya Dei |
| Designation |
Professor And HOD |
| Affiliation |
Institute for Post Graduate Training And Research Centre |
| Address |
OPD 12 5th floor Department of Prasuti Tantra And Stree Roga IPGT and RA GAU Jamnagar GUJARAT 361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
7874982753 |
| Fax |
|
| Email |
deilaxmipriya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute For Post Graduate Training And Research In Ayurveda, Gujarat Ayurveda University Jamnagar Gujarat 361008.pharmacy of GAU ,jamnager.
|
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Training And Research Centre |
| Address |
Gujarat Ayurved University Jamnagar
|
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 |
| Nilima Gamit |
PG Hospital IPGT and RA Jamnagar |
PG Hospital Shalya Tantra Department ,opd no.1 IPGT and RA Jamnagar Gujarat.
Jamnagar
GUJARAT |
9409186162
gamitnilima222@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient diagnosed with Raktaja Arsha (1st, 2nd& 3rd degree) , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Effect of Palashkshara Application With And Without Kankayan Vatak In The Management Of Rakatjaarsha (1 st 2 nd and 3 rd Degree Hemorrhoids ) |
in group group A palash kshara application 1-3 sitthing done as per requirement.and group B palash kshara application 1-3 sitthing done as per requirement on rakataj arsha With kankayan vatak 500mg bd orally for 15 days. |
| Intervention |
palash kshara application |
group A palash kshara application 1-3 sitthing done as per requirement. |
| Comparator Agent |
palash kshara application with kankayan vatak 500mg BD for 15 days. |
group B Palash kshara application( 1-3) sitting with kankayan vatak 500 mg bd for 15 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
age 18 to 70 years either gender
patient who are suffering from 1st ,2nd and 3rd degree
soft,deep seated and elevated piles |
|
| ExclusionCriteria |
| Details |
age less than 18 years and more than 70 years
4th degree piles
rectal prolapse
malignancy of ano rectum
pregnanat woman
hepatitis B,T.B,HIV& VDRL positive cases
uncontrolled HTN,DM cardiac malignancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of raktaja arsha |
Relief in sign and symptoms of raktaja arsha in 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improves quality of life of person |
improves quality of life of person in 1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/03/2018 |
| 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 published yet
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study comprises a Clinical Study to evaluate Efficacy of Palash Kshara Application with and without kankayan vatak in the Management of Arsha (1st & 2nd ,3rddegree hemorrhoids) –. Kshara Karma and Agni karma therapy have been identified as para-surgical measures having minimal invasive procedures. These procedures have many advantages like-simple, safe, effective, ambulatory and known for minimal or no complications, less time to stay in the hospital and minimal disturbance in patient’s routine work. That’s why it is readily acceptable to patients. Kshara Karma procedure interpreted to potential cauterization application therapy is the specific field taken in to research for finding out the better approach in comparison to the modern counterpart. In relation to Kshara Karma, Sushruta has advocated Kshara Pratisaran, which is a quite relevant method for the cases of internal piles of 1st and 2nd degrees.groupn A only Palash Kshara Application done.and group B Palash Kshara Application with kankayan vatak 500bd for after given for 15 day. and befor and after these procedure sitz bath in panchvalkal kawath and errand bhristha haritaki , and matrabasti of jatyadi tail given. Symptoma like analysis PR Bleeding, discomfort, constipation etc Local examination done like Inspection, Palpation, Per Rectum Digital Examination, Proctoscopic examination.follow up 4 weeks.
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