| CTRI Number |
CTRI/2019/01/016908 [Registered on: 04/01/2019] Trial Registered Prospectively |
| Last Modified On: |
31/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF APAMARGA PRATISARANEEYA KSHARA AND KARAVEERA PRATISARANEEYA KSHARA IN ARDRA ARSHAS W S R TO INTERNAL HAEMORRHOIDS |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Apamarga Pratisaraneeya Kshara And Karaveera Pratisaraneeya Kshara In Ardra Arshas W S R To Internal Haemorrhoids |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BHARAT KUMAR M |
| Designation |
POST GRADUATE SCHOLAR |
| Affiliation |
SRI KALABHYRAVESHWARASWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
NO 10 PIPE LINE ROAD RPC LAYOUT VIJAYANAGAR BENGALURU
DOOR NO 661 21ST CROSS 2ND BLOCK RAJAJI NAGAR BANGALORE
Bangalore
KARNATAKA
560104
India |
| Phone |
8095512097 |
| Fax |
|
| Email |
bharathayu1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHAILAJA SV |
| Designation |
PROFESSOR |
| Affiliation |
SRI KALABHYRAVESHWARASWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
NO 10 PIPE LINE ROAD RPC LAYOUT VIJAYANAGAR BENGALURU
Bangalore
KARNATAKA
560104
India |
| Phone |
988097253 |
| Fax |
|
| Email |
shailajaramkumar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHAILAJA SV |
| Designation |
PROFESSOR |
| Affiliation |
SRI KALABHYRAVESHWARASWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
NO 10 PIPE LINE ROAD RPC LAYOUT VIJAYANAGAR BENGALURU
KARNATAKA
560104
India |
| Phone |
988097253 |
| Fax |
|
| Email |
shailajaramkumar@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR BHARAT KUMAR M |
| Address |
NO 10 PIPE LINE ROAD RPC LAYOUT VIJAYANAGAR BENGALURU 560 104 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHAILAJA SV |
SRI KALABHYRAVESHWARASWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
NO 10 PIPE LINE ROAD RPC LAYOUT VIJAYANAGAR BENGALURU 560 104
Bangalore
KARNATAKA |
9880917253
shailajaramkumar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCH & RC |
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 |
| Intervention |
APAMARGA PRATISARANEEYA KSHARA |
APPLICATION OF APAMARGA PRATISARANEEYA KSHARA IN ARDRA ARSHAS W S R TO INTERNAL HAEMORRHOIDS |
| Comparator Agent |
KARAVEERA PRATISARANEEYA KSHARA |
APPLICATION OF KARAVEERA PRATISARANEEYA KSHARA IN ARDRA ARSHAS W S R TO INTERNAL HAEMORRHOIDS |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS SUFFERING FROM FIRST AND SECOND DEGREE HAEMORRHOIDS
PATIENTS WITH EITHER SEX AGED BETWEEN 21 TO 60 YRS
|
|
| ExclusionCriteria |
| Details |
HAEMORRHOIDS OF THIRD AND FOURTH DEGREE
EXTERNAL HAEMORRHOIDS
PATIENTS WITH OTHER SYSTEMIC DISEASE INTERFERING 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 |
| Efficacy of Intervention Over Subjective and Objective Criteria of Ardra Arshas W S R to Internal Haemorrhoids |
21 Days |
|
|
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)
|
17/01/2019 |
| 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="3"
Days="15" |
|
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)?
|
|
Brief Summary
|
ARSHAS CAN BE COMPARED TO HAEMORRHOIDS IN THE
CONTEMPORARY SCIENCE.
HAEMORRHOIDS
ARE THE DILATED VEINS FORMED WITHIN ANAL CANAL IN THE SUB EPITHELIAL REGION
FORMED BY THE RADICLES OF SUPERIOR, MIDDLE AND INFERIOR RECTAL VEINS.
HAEMORRHOIDS IS ONE OF THE MOST COMMONEST DISEASE WHICH OCCUR IN ANO RECTAL
REGION AND ITS INCIDENCE INCREASES WITH ADVANCING AGE AND ATLEAST 50% OF PEOPLE
OVER THE AGE OF 50 HAVE SOME SYMPTOMS RELATED TO HAEMORRHOIDS.
THE DRUGS APAMARGA AND KARAVEERA HAS BEEN
MENTIONED UNDER PRATISARANEEYA DRAVYAS IN SUSHRUTA SAMHITA. HENCE
THIS STUDY IS AIMED TO EVALUATE THE EFFICACY OF KARAVEERA PRATISARANEEYA WITH
APAMARGA PRATISARANEEYA KSHARA IN ARDRA ARSHAS W.S.R TO INTERNAL HAEMORRHOIDS |