| CTRI Number |
CTRI/2021/02/031304 [Registered on: 16/02/2021] Trial Registered Prospectively |
| Last Modified On: |
15/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare the effect of two alkalie (pongamia pinnata and plumbago zylanica )in piles |
|
Scientific Title of Study
|
an open label double arm study on the effect of karanja pratisaraneeya kshara and chitraka pratisaraneeya kshara in abhyantara arshas vis a vis internal haemorrhoids |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KAVYA V |
| Designation |
pg scholar department of shalya tantra |
| Affiliation |
sri kalabyraveshwara swamy ayurvedic medical college hospital and research center |
| Address |
Department of shalya tantra sri kalabyraveshwara swamy ayurvedic medical college hospital and research center no 10 pipeline road RPC layout vijayanagar 2nd stage bangalore
Department of shalya tantra no 10 pipeline road RPC layout vijayanagar bangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
8892994440 |
| Fax |
|
| Email |
budigerekavya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHAILAJA S V |
| Designation |
professor and HOD department of shalya tantra |
| Affiliation |
sri kalabyraveshwara swamy ayurvedic medical college hospital and research center |
| Address |
Department of shalya tantra sri kalabyraveshwara swamy ayurvedic medical college hospital and research center no 10 pipeline road RPC layout vijayanagar 2nd stage bangalore
no 10 pipeline road RPC layout vijayanagar 2nd stage bangalore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9880917253 |
| Fax |
|
| Email |
shailajaramkumar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHAILAJA S V |
| Designation |
professor and HOD department of shalya tantra |
| Affiliation |
sri kalabyraveshwara swamy ayurvedic medical college hospital and research center |
| Address |
Department of shalya tantra sri kalabyraveshwara swamy ayurvedic medical college hospital and research center no 10 pipeline road RPC layout vijayanagar 2nd stage bangalore
no 10 pipeline road RPC layout vijayanagar 2nd stage bangalore 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9880917253 |
| Fax |
|
| Email |
shailajaramkumar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Self sponsored department of shalya tantra
Sri KALABYRAVESHWARASWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE . |
|
|
Primary Sponsor
|
| Name |
Dr KAVYA V |
| Address |
sri kalabyraveshwara swamy ayurvedic medical college hospital and research center no 10 pipeline road RPC layout vijayanagara 2nd stage bangalore |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 |
| DR KIRAN M GOUD |
SKAMCHRC |
Principal sri kalabyraveshwara swamy ayurvedic medical college hospital and research center no 10 pipeline road RPC layout vijayanagara bangalore
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCHRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: Abhyantara Arshas , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chitraka kshara |
Chitraka pratisaraneeya kshara ano rectal route administration duration for 21days dose is according to size of mass |
| Intervention |
Karanja kshara |
Karanja pratisaraneeya kshara ano rectal route administration duration for 21days .dose according to size of mass |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with abhyantara arshars suitable for kshara karma subjects suffering from second degree internal hemorrhoids |
|
| ExclusionCriteria |
| Details |
Strangulated and thrombosed internal hemorrhoids. Fourth degree internal hemorrhoids. External hemorrhoids. Subjects with other systemic diseases interfering with the treatment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of effect of Karanja pratisaraneeya kshara and chitraka pratisaraneeya kshara within 21days for 3weeks |
Comparison of effect of Karanja pratisaraneeya kshara and chitraka pratisaraneeya kshara within 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
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 |
|
Date of First Enrollment (India)
|
18/02/2021 |
| 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="2"
Months="1"
Days="27" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Arshas is defined as arivat pranan shrinoti hinsati .It is one of the commonest anorectal disease . Arshas can be considered as haemorrhoids .The incidence increases as age advances at least 50% of people over the age 50yrs have some degree of haemorrhoidal symptoms . The management of haemorrhoids have one or the other type of limitations and post op complications . Hence it leaves a scope to find out the remedy to cure the disease free from complication .kshara karma is a minimal invasive technique .Drugs like Karanja and chitraka have been mentioned in ksharapaka vidhi adhyaya .Both are easily available and cost effective Hence this study is taken up for evaluation in abhyantara arshas |