| CTRI Number |
CTRI/2021/07/034976 [Registered on: 19/07/2021] Trial Registered Prospectively |
| Last Modified On: |
15/07/2021 |
| 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 triphala guggulu and nimba patradi lepa in parikartika (Fissure in ano) |
|
Scientific Title of Study
|
Evaluation of Nimba Patradi lepa 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 |
Dr Ranjeet Singh |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan Haridwar |
| Address |
Opd 15, shalya tantra department,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9736361528 |
| Fax |
01334-244805 |
| Email |
ranjeetsidhu36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjeet Singh |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan Haridwar |
| Address |
Opd 15, shalya tantra department, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9736361528 |
| Fax |
01334-244805 |
| Email |
ranjeetsidhu36@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Gupta |
| Designation |
Professor and HOD |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Evam Sansthan Haridwar Haridwar |
| Address |
Opd 15, Shalya Department , PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9419135050 |
| Fax |
01334-244805 |
| Email |
chintu.925@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurvedic Hospital, Haridwar, uttrakhand |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurvedic College Haridwar Uttarakhand |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Uttarakhand 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 Ranjeet Singh |
Patanjali Ayurvedic Hospital |
Patanjali Bhartiya Ayurvigyan evam Anusandhan Sansthan, Haridwar
Hardwar
UTTARANCHAL |
9736361528
ranjeetsidhu36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee patanjali ayurvedic College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nimba Patradi lepa for local application |
Apply nimba patradi lepa locally over anal fissure till the disappearance of disease |
| Intervention |
Triphala Guggulu Orally |
Triphala Guggulu Orally 2 tab bd half an hour after meal with luke warm water for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical feature of acute and chronic fissure in ano.
Patients having fissure in ano with or without tag. |
|
| ExclusionCriteria |
| Details |
Patient having Parikartika secondary to known case of Ulcerative Colitis, Crohn’ s
diseases, Tuberculosis and Syphilis will be excluded.
Patients with uncontrolled systemic disorders like–Diabetes mellitus, uncontrolled
hypertension, ischemic heart disease
Patients with any type of endocrinal disorders
HIV, Hepatitis B and Hepatitis C positive patients.
Patient with evidence of malignancy.
Patients having IBS and Diarrhea.
Patient with any other ano rectal diseases like Rectal prolapse, Fistula in ano,
Haemorrhoid etc. will be excluded . |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameters-
pain
constipation
Burning sensation
Bleeding per rectum
Itching
Objective Parameters-
Size of Ulcer
Depth ofUlcer |
1month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective parameters-
pain
constipation
Burning sensation
Bleeding per rectum
Itching
Objective Parameters-
Size of Ulcer
Depth ofUlcer |
3 months |
|
|
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)
|
23/07/2021 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
In this trial, we are selecting the patients of Parikartika (Fissure in ano) In which we will do the intervention with Ayurvedic medicine Nimba Patradi lepa for local application in anal region twice a day and Triphala Guggulu Orally 2 tab BD for 15 Days assessment should be done on the basis of investigation done during pre and post treatment as discussed earlier. |