| CTRI Number |
CTRI/2020/02/023229 [Registered on: 10/02/2020] Trial Registered Prospectively |
| Last Modified On: |
07/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study To Compare The Efficacy And Safety Of Arsha Hita In The Treatment Of Anal Fissure |
|
Scientific Title of Study
|
A Prospective, Randomized, Active-Controlled, Two-Arm,Parallel Group, Assessor-Blind Study To Compare The Efficacy And Safety Of Arsha Hita In The Treatment Of Anal Fissure |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gopikrishna BJ |
| Designation |
PROFESSOR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and HospitaL |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9886360901 |
| Fax |
|
| Email |
drgopiboyapati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suhas Kumar Shetty |
| Designation |
PROFESSOR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and HospitaL |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9449603234 |
| Fax |
|
| Email |
drsuhasshetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopikrishna BJ |
| Designation |
PROFESSOR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and HospitaL |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9886360901 |
| Fax |
|
| Email |
drgopiboyapati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Dhootpapeshwar ltd, Reg.Office 135
Nanubhai Desai Road
Khetwadi,Mumbai - 400004
Maharashtra |
|
|
Primary Sponsor
|
| Name |
Shree Dhootapapeshwar Limited |
| Address |
Shree Dhootapapeshwar Limited,
135, Nanubhai Desai Road, Khetwadi, Mumbai – 400004
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 GOPIKRISHNA BJ |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Department of Shalya Tantra,
OPD 11 and In patient Department Of Shalya Tantra
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA |
9886360901
drgopiboyapati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K602||Anal fissure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (standard treatment group) |
They will be advised to apply locally Lidocaine 1.5 + Nefidipine 0.3% three times a day and take one sachet of Isabgol powder(6g) in 200 ml lukewarm water at bed time |
| Comparator Agent |
Group B (ArshaHita treatment group): |
Patients of group B will be givenArshaHita Tablets & Cream and advised to use them as follows:
1. ArshaHita Tablets: 2 tablets to be taken twice a day with lukewarm water.
2. ArshaHita ointment: To be applied before and after evacuation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients aged between 18 - 60 years of either sex.
2. Patients with a confirmed diagnosis of anal fissure
3. Patients with previous history of no treatment or only conservative treatment, consisting of sitz bath and/or Isabgol powder and/or high fibre diet in the last 1 month.
4. Patients with a composite score of > 4 at baseline visit.
|
|
| ExclusionCriteria |
| Details |
1.Patients having anal fistulas or anal fissure of various causes such as Crohn’s disease, anal suppuration, abscesses (Secondary underlying causes).
2.Patients having anal or perianal malignancy.
3.Patients with diagnosis of any illness (other than anal fissure) with presentation of per-anal bleeding
4.Patients with history of > 3 recurrences of anal fissure post medical or surgical intervention.
5.Patients on oral calcium channel blockers or vasodilators like minoxidil, hydralazine or alprostadil.
6.Patients who have a history of topical therapy with nitroglycerine/ lignocaine/ steroids/ calcium channel blockers in the past one month.
7.Patients who are pregnant or lactating.
8.Patients with history of life threatening cardiovascular and /or neurological event in the past one year.
9.Patients with auto-immune disease, uncontrolled hypertension, uncontrolled diabetes mellitus(requiring change in antidiabetic therapy every 3 months) and chronic severe respiratory disease.
10.Patients with documented evidence of renal function tests > 1 and a half times of normal reference range at baseline visit
11.Patients withdocumented evidence of liver function tests > 2 and a half times of normal reference rangeat baseline visit
12.Patients with history of HIV/HBV/HCV infection in the past.
13.Patients on herbaceutical medication since the last 3 months.
14.Patient allergic to any of the ingredients of trial drug or the comparator drug
15.Patients currently participating in another clinical trial for any indication or has participated in any clinical trial in the last 30 days.
16.Patient not willing to sign on the informed consent document or not willing to come for follow-up visits
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The number of patients of anal fissure
showing a 90% reduction in the composite score in the
Arsha Hitagroup as compared with the standard treatment
group of Lidocaine 1.5 + Nefidipine 0.3% gel and oral
Isabgol. |
Study duration for 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Before treatment and after 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
14/02/2020 |
| 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
|
study not initiated |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The use of topical agents in anal
fissures like lignocaine, nitrates, diltiazem as well as the use of
conservative treatment like sitz bath, isabgol and high fiber diet has not been
found to completely relieve the patients from the signs and symptoms. The
topical treatment like nitrates and diltiazem are associated with various
side-effects. 20% of the patients on nitrates suffer from headaches while 15%
of the patients on diltiazem complain of itching. Many of the patients of acute
anal fissure progress to chronic anal fissure. Also, the surgical treatment of
anal fissures is associated with complications like anal incontinence, with
post-surgical recurrences of anal fissures also reported. Arsha Hita, a polyherbal formulation kit, is being
marketed from 10 years and is indicated in bleeding, pain, anal discomfort and
inflammation associated with haemorrhoids. However, no validation study has
been conducted to check its efficacy in the treatment of anal fissures. Thus, a
single centre, prospective, randomized, active-controlled, two-arm, parallel
group, assessor blind study is planned to validate the efficacy of Arsha Hita in patients of anal fissures. |