| CTRI Number |
CTRI/2021/02/031255 [Registered on: 12/02/2021] Trial Registered Prospectively |
| Last Modified On: |
12/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The clinical study to compare and evaluate the effect of madhughrita pratisaran with calcium dobesilate in the management of raktarsha |
|
Scientific Title of Study
|
A randomised comparative clinical trial to evaluate the efficacy of madhughrita pratisaran with calcium dobesilate in management of raktarsha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nutan Valmik Sanap |
| Designation |
PG second year |
| Affiliation |
PDEAs college of ayurved and research centre,Nigdi |
| Address |
Ayurved rugnalay and sterling multispeciality hospital Sector no
27 pradhikaran Nigdi Pune
Ayurved rugnalay and sterling multispeciality hospital Sector no
27 pradhikaran Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8623052764 |
| Fax |
- |
| Email |
nutanpratap007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat oza |
| Designation |
Associate professor shalyatantra department |
| Affiliation |
PDEAs college of ayurved and research centre, Nigdi |
| Address |
Ayurved rugnalay and sterling multispeciality hospital Sector no
27 pradhikaran Nigdi Pune
Ayurved rugnalay and sterling multispeciality hospital Sector no
27 pradhikaran Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9970254593 |
| Fax |
- |
| Email |
drbharat_oza@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr nutan sanap |
| Designation |
pg 2nd year |
| Affiliation |
PDEAs college of ayurved and research centre, Nigdi |
| Address |
Ayurved rugnalay and sterling multispeciality hospital Sector no
27 pradhikaran Nigdi Pune
Ayurved rugnalay and sterling multispeciality hospital Sector no
27 pradhikaran Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8623052764 |
| Fax |
- |
| Email |
nutanpratap007@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurved and research centre sector no 27 Pradhikaran nigdi 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurved and research centre |
| Address |
sector n 27 Pradhikaran nigdi 411044 |
| 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 |
| Dr Nutan Valmik Sanap |
shalya opd no 123Ayurved rugnalaya and sterling multyspecialty hospital.Nidgi |
sector n 27 Pradhikaran Nigdi pune 411044
Maharashtra
Pune
MAHARASHTRA |
8623052764
-
nutanpratap007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K649||Unspecified hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium dobesilate |
Group B will be treated with calcium dobesilate application for 7 days
|
| Intervention |
Madhughrita pratisaran |
Group A will be treated with
Madhughrita pratisaran application for 7 days
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age 20 yrs to 50 yrs
Both male and female
1st 2nd 3rd degree hemorrhoides
Bleeding piles |
|
| ExclusionCriteria |
| Details |
Prolapsed of the rectum
Perianal abscess
Rectal polyp
K/c/o fistula in ano
K/c/o Crohns disease
K/c/o Diverticulitis
K/c/o Malignancy
K/c/o Hypertension
K/c/o Bleeding disorders
Hn less than 7gm% |
|
|
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 |
| To compare the effect of madhughrita pratisaran with calcium dobisilate in 7 days in the management of raktersha on the basis of visual analogus scale and goniometer measurements |
difference in bleeding , kleda, grade of piles on 3rd, 5th, 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study adverse effect if any |
difference in bleeding , kleda, grade of piles on 3rd, 5th, 7th day |
|
|
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)
|
15/02/2021 |
| 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="1"
Months="6"
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)?
Response - NO
|
|
Brief Summary
|
one of the most common ano rectal condition is hemorrhoids hemorrhoidsis also called piles are vasular structures in the anal canal, they become a disease when swollen or inflamed,
madhughrita pratisaran- madhughrita pratisaran is considered as best for raktaresha,
calcium dobisialte- it is combimation of calcium dobisilate 0.25% + hydrocortisone 0.25%+ lignocaine 3%+ zinc oxide 5% it is used for local application, it it local anesthetic, anti inflammatory and venous decongestant and improves vinous tone
in my study i am going to study and compare the effect of madhughrita pratisaran with calcium dobisilate in the management of raktarsha |