| CTRI Number |
CTRI/2020/03/023853 [Registered on: 09/03/2020] Trial Registered Prospectively |
| Last Modified On: |
06/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study efficacy of jati tail in fissure in ano. |
|
Scientific Title of Study
|
“A Randomized Comparative Clinical Trial To Compare The Efficacy Of Durva Tail with Jati Tail In Acute Fissure in ano (Parikartika).â€
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Preeti Verma |
| Designation |
PG Student |
| Affiliation |
PDEAs college of ayurved and research center, Nigdi, Pune |
| Address |
Department Shalyatantra OPD no. 123, Ayurved Rugnalaya and
Sterling Multispeciality Hospital, Sector no.27, Pradhikaran, Nigdi,
Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9130269559 |
| Fax |
|
| Email |
preetivermabhosale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhalchandra N Deshpande |
| Designation |
HOD Shalyatantra Department |
| Affiliation |
PDEAs college of ayurved and research center, Nigdi, Pune |
| Address |
Department Shalyatantra OPD no. 123, Ayurved Rugnalaya and
Sterling Multispeciality Hospital, Sector no.27, Pradhikaran, Nigdi,
Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9970108596 |
| Fax |
|
| Email |
dr.bndeshpande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhalchandra N Deshpande |
| Designation |
HOD Shalyatantra Department |
| Affiliation |
PDEAs college of ayurved and research center, Nigdi, Pune |
| Address |
Department Shalyatantra OPD no. 123, Ayurved Rugnalaya and
Sterling Multispeciality Hospital, Sector no.27, Pradhikaran, Nigdi,
Pune.
Pune
MAHARASHTRA
411044
India |
| Phone |
9970108596 |
| Fax |
|
| Email |
dr.bndeshpande@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of ayurved and research center Sector no. 25 Pradhikaran Nigdi Pune |
|
|
Primary Sponsor
|
| Name |
Principal PDEAs College of Ayurved and Research center |
| Address |
PDEAs College of Ayurved and Research center, Nigdi, Pradhikaran,
Sector 25, pune 44 |
| 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 Preeti Verma |
Ayurved Rugnalaya and Sterling Multispeciality hospital |
Sector no 27
Pradhikaran Nigdi
Pimpri Chinchwad Pune
411044
Pune
Pune
MAHARASHTRA |
9130269559
preetivermabhosale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K600||Acute anal fissure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DURVA TAIL |
Durva kwath will be boiled with til tail till it appears Tail sidhhi lakshane.twice a day local application with common oral drug Triphala churna for 7 days with follow up after 7 days |
| Intervention |
JATI TAIL |
Jati kwath will be boiled with til tail till it appears Tail sidhhi lakshane.twice a day local application with common oral drug Triphala churna for 7 days with follow up after 7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of age between 18 to 60 years.
2 Physical examination revealed fissure in ano.
3 The patient who having classical signs and symptoms of acute fissure in ano will be selected for present clinical study.
|
|
| ExclusionCriteria |
| Details |
1 k/c/o fissure in Ano due to any secondary cause
2 k/c/o Parikartika (Fissure in ano) secondary to Ulcerative colitis, Syphilis, Crohn’s disease, Tuberculosis and Ca of rectum and anal canal.
3 Not willing to give consent.
4 Chronic Fissure
|
|
|
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 efficacy of durva tail with jati tail in acute fissure in ano (parikartika) applying locally twice a day for seven days. |
twice a day for 7 days, follow up after 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. to study the efficacy of durva tail with jati tail in acute fissure in ano (parikartika)
2. To observe side effects if any |
twice a day for 7 days, follow up after 7 days |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
11/03/2020 |
| 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="0"
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)?
|
|
Brief Summary
|
In the era of fast food, there is change or irregularity
in diet and diet timings and also sedentary life style. In addition to change
in diet and life style, one is always under tremendous mental stress. All these
causes disturb in digestive system which results into many diseases amongst
them ano-rectal disorder constitute an important group. It results into
indigestion and constipation like problem; further constipation and hard stool
are results into tear of skin in anal region and leads to chronic condition
i.e. anal fissure. Anal Fissure is one of the major causes for pain in anal
region. On the basis of symptoms, the disease fissure-in-ano can be compared to
the disease Parikartika according to Ayurveda. Acharya Dalhana has described
the term Parikartika as a condition of Guda in which there is cutting and
tearing pain Fissure-in-ano is very common and painful condition to the
patients hampering quality of life. Fissure occurs most commonly in the midline
posteriorly. |