| CTRI Number |
CTRI/2020/12/029781 [Registered on: 14/12/2020] Trial Registered Prospectively |
| Last Modified On: |
11/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
The study of triphala ghrita and go ghrita local application in cases of fissure in ano |
|
Scientific Title of Study
|
The comparitive study between local application of go ghrita and triphala ghrita in parikartika(fissure in ano)-A randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Chandrakant Babar |
| Designation |
PhD Scholar |
| Affiliation |
Dr.D. Y. Patil College Of Ayurved and Research Centre Pune |
| Address |
opd no 3 deparment of shalyatantra 3 rd floor Dr D Y Patil college of ayurved and research centre pimpri sant tukaram nagar pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay C Babar |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil deemed to be University ,Pune-18 |
| Address |
Dr D Y Patil college of ayurved and research centre opd no 3 deparment of shalyatantra 3 rd floor pimpri sant tukaram nagar pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Chandrakant Babar |
| Designation |
PhD Scholar |
| Affiliation |
dr d y patil college of ayurved and research centre |
| Address |
Dr D Y Patil college of ayurved and research centre opd no 3 deparment of shalyatantra pimpri sant tukaram nagar pune 411018
Dr D Y Patil college of ayurved and research centre opd no 3 deparment of shalyatantra pimpri sant tukaram nagar pune 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9011035602 |
| Fax |
|
| Email |
sanjaybabar14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil college of ayurved and research centre pimpri pune 411018 |
|
|
Primary Sponsor
|
| Name |
Dr sanjay Chandrakant Babar |
| Address |
opd no 3 department of shalyatantra 3rd floor Dr D Y Patil college of ayurved and research centre pimpri pune 411018 |
| Type of Sponsor |
Other [self] |
|
|
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 Sanjay Chandrakant Babar |
Dr D Y Patil college of ayurved and research centre pimpri pune |
shalyatantra opd no 3 department of shalyatantra pimpri sant tukaram nagar pune 411018
Pune
MAHARASHTRA |
9011035602
drsanjaybabar14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.D.Y.Patil College Of Ayurved and Research Centre, Pimpri, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, (2) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
local application of Go ghrita |
drug - go ghrita
route of administration - local application
disease- parikartika (fissure in ano)
dose- 2 ml
frequency- at night only
duration - for 15 days
Follow up 0,5th , 10th,15th
|
| Intervention |
local application of triphala ghrita |
drug - Triphala ghrita route of administration - local application disease- parikartika (fissure in ano) dose- 2 ml frequency- at night only duration - for 15 days Follow up 0,5th , 10th,15th |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients having classical features of fissure in ano namely pain in anal region during and after defecation per rectal bleeding , cutting / burning pain , longitudnal ulcer in the anal region will be selected.
Acute solitary fissures will be included .
Patient suffering from parikartika as per ayurvedic classics will be selected |
|
| ExclusionCriteria |
| Details |
Patients suffering from any other rectal diseases.
Patient suffering from systemic disoders like HTN , DM etc
Patients on anticoagulant drugs
Patients suffering from infectious diseases like kochs |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the results of triphala ghrita application over plain ghrita application |
follow up 0 , 5th , 10th and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| standardisation of triphala ghrita and plain Go-ghrita |
follow up 0 , 5th , 10th , 15th day |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 3 |
|
Date of First Enrollment (India)
|
14/12/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim of the study to give ayurvedic treatment . The patient who are suffuring from diasease acute fissure in ano for not only improve the condition but also protect from recurrence of the disease along with this we can give safe , cheap and side effect free management in the form of ghrita kalpana . The trial will be conducted over 100 patients of each group for 15 days and conclusion will be drawn from collected data. |