| CTRI Number |
CTRI/2020/11/029129 [Registered on: 13/11/2020] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Arshkeyt in Anal Fissure |
|
Scientific Title of Study
|
An Open Labelled phase 4 Single Group Proof-of-concept study to evaluate the
Efficacy & Safety of Arshkeyt, a 7 day kit in patients suffering from Anal
fissures. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivekanand Kullolli |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 403, Dept of Shalya Tantra
Parul Institute of Ayurved, Parul University Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9945079276 |
| Fax |
|
| Email |
vivekanand.kullolli26833@paruluniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivekanand Kullolli |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 403, Dept of Shalya Tantra
Parul Institute of Ayurved, Parul University Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9945079276 |
| Fax |
|
| Email |
vivekanand.kullolli26833@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivekanand Kullolli |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room No 403, Dept of Shalya Tantra
Parul Institute of Ayurved, Parul University Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9945079276 |
| Fax |
|
| Email |
vivekanand.kullolli26833@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Ayurved Hospital
Khemdas Ayurved Hospital |
|
|
Primary Sponsor
|
| Name |
Solumiks Herbaceuticals Limited |
| Address |
135, Nanubhai Desai Rd, Charni road east, Khetwadi, Girgaon, Mumbai, Maharashtra 400004 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Superintendent |
Khemdas Ayurved Hospital, At- Ishwarpura, PO-Limda, TAQ-Waghodia, Dist- Vadodara, Gujarat |
| Superintendent |
Parul Ayurved Hospital, PO-Limda, Taq- Waghodia Vadodara Gujarat |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Khemchandra Mahajan |
Khemdas Ayurved Hospital |
Ishwarpura, PO- Limda Waghodia
Vadodara
GUJARAT |
9763443730
khemchandra.mahajan86270@paruluniversity.ac.in |
| Dr Vivekanand Kullolli |
Parul Ayurved Hospital |
PO-Limda, Waghodia
Vadodara
GUJARAT |
9945079276
vivekanand.kullolli26833@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee-PIA (IECHR) |
Approved |
| Institutional Ethical Committee-PIAr (IECHR) |
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 |
Arshkeyt- Kit |
1. Arshkeyt Tablets: 2 tablets thrice a day with
sufficient water.
2. Arshkeyt Cream: To be applied at least twice a day
and after each act of defecation.
3. Arshkeyt Powder: One sachet to be taken at bed time
with sufficient water. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 range at 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
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing of Anal Fissure |
6 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relive from Constipation and Hard stool |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/11/2021 |
| Date of Study Completion (India) |
14/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anal fissure is a tear occurring in the anal canal, beginning from the dentate line and extending up to the anal verge.
They are characterised symptomatically by pain during or after defecation, anal bleeding and spasms of the anal sphincter.
Anal fissures are equally seen in both males and females. It is most commonly seen in the middle aged and the young patients, with the mean age of onset being 39.9 years.
The anal fissures have been classified arbitrarily as acute and chronic anal fissures, based on the duration of the presenting symptoms.
Patients with symptoms for less than 6 weeks in duration are considered to be suffering from acute anal fissure.
The non-operative treatment options for cases of anal fissures are sitz bath, local anaesthetics, topical nitrates, oral intake of fibre, laxatives and topical or oral calcium channel blockers. Patients of chronic anal fissures with long term symptoms may be taken up for surgery which carries an important complication of anal incontinence.
Thus, there is a need of new treatment modalities for relief in the patients with anal fissure with minimum side- effects. The Study is multi-centric,prospective, phase 4 trial. |