| CTRI Number |
CTRI/2020/12/029893 [Registered on: 17/12/2020] Trial Registered Prospectively |
| Last Modified On: |
17/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the effect Of Doorvadi Ghrita for local application
and Triphala Guggulu orally in Parikartika (Fissure In Ano) |
|
Scientific Title of Study
|
A Clinical Study TO Evaluate The Effect Of Doorvadi Ghrita Along With Triphala Guggulu In Parikartika (Fissure In Ano) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti Saini |
| Designation |
PG SCHOLAR |
| Affiliation |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan phase 1 phase 1 |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR UTTRAKHAND.249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9416959136 |
| Fax |
01334-244805 |
| Email |
js1770693@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyoti Saini |
| Designation |
p.g. scholar |
| Affiliation |
Patanjali bhartiya ayurvigyan evam anusandhan sansthan phase 1 phase 1 |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR UTTRAKHAND.249405
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR UTTRAKHAND.249405
UTTARANCHAL
249405
India |
| Phone |
9416959136 |
| Fax |
01334-244805 |
| Email |
js1770693@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sachin gupta |
| Designation |
Associate professor |
| Affiliation |
opd 15 department of surgery patanjali ayurvedic hospitaL. |
| Address |
OPD 15 SHALYA DEPARTMENT PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR UTTRAKHAND.249405
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR UTTRAKHAND.249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9419135050 |
| Fax |
01334-244805 |
| Email |
Chintu.925@gmail.com |
|
|
Source of Monetary or Material Support
|
| PATANJALI AYURVEDIC HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurveda College |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR UTTRAKHAND.249405 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 jyoti saini |
Patanjali ayurvedic hospital |
opd no 15 dept
of shalya tantra ,Patanjali ayurvedic college and hospital haridwar
Hardwar
UTTARANCHAL |
9416959136
01334-244805
js1770693@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee patanjali ayurvedic collegei |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: disorder of anal region, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Doorvadi ghrita for Local application |
Doorvadi ghrita for local application for till the disappearence of fissure in ano |
| Intervention |
Triphala guggulu 2 tab bd |
Triphala guggulu 2 tab bd after meal for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients having fissure in ano with or without tag. |
|
| ExclusionCriteria |
| Details |
1 Patient having Parikartika secondary to known case of Ulcerative Colitis, Crohn’ s diseases, Tuberculosis and Syphilis will be excluded.
2 Patient of either sex, age less than 18 years and more than 70 years
3 Patients with uncontrolled systemic disorders like–Diabetes mellitus, tuberculosis, uncontrolled hypertension, ischemic heart disease.
4 Patients with any type of endocrinal disorders.
5 HIV and Hepatitis B/C positive patients.
6 Patient with evidence of malignancy
7 Patient with any other ano rectal diseases.
8 Patients having IBS and Diarrhoea.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 PAIN
2 CONSTIPATION
3 BURNING SENSATION IN ANAL CANAL
4 BLEEDING
5 ITCHING
|
90 days |
|
|
Secondary Outcome
|
|
|
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 |
|
Date of First Enrollment (India)
|
19/12/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
IN THIS TRIAL WE ARE SELECTING THE PATIENT OF PARIKARITKA(FISSURE IN ANO) IN WHICH WE WILL DO THE INTERVENTION THE AYURVEDIC MEDICINE DOORVADI GHRITA FOR LOCAL APPLICATION IN ANAL REGION AND TRIPHALA GUGGULU 2 TABLET BD FOR 15 DAYS ASSESMENT SHOULD BE DONE ON THE BASIS OF INVESTIGATION DONE DURING PRE TREATMENT AND POST TREATMENT AS DISCUSSED EARLIER |