| CTRI Number |
CTRI/2017/09/009648 [Registered on: 05/09/2017] Trial Registered Prospectively |
| Last Modified On: |
29/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homeopathic treatment of fissure in anus |
|
Scientific Title of Study
|
Individualized homeopathic treatment of anal fissure: a double-blind, randomized, placebo-controlled, clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1201-6483 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubhamoy Ghosh |
| Designation |
Professor and Head |
| Affiliation |
Dept. of Pathology & Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College & Hospital |
| Address |
Drainage Canal Road, Doomurjala, Howrah
Haora
WEST BENGAL
711104
India |
| Phone |
9831034229 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shubhamoy Ghosh |
| Designation |
Professor and Head |
| Affiliation |
Dept. of Pathology & Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College & Hospital |
| Address |
Drainage Canal Road, Doomurjala, Howrah
Haora
WEST BENGAL
711104
India |
| Phone |
9831034229 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhamoy Ghosh |
| Designation |
Professor and Head |
| Affiliation |
Dept. of Pathology & Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College & Hospital |
| Address |
Drainage Canal Road, Doomurjala, Howrah
Haora
WEST BENGAL
711104
India |
| Phone |
9831034229 |
| Fax |
|
| Email |
shubhamoy67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahesh Bhattacharyya Homoeopathic Medical College & Hospital, Govt. of West Bengal |
|
|
Primary Sponsor
|
| Name |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital |
| Address |
Drainage Canal Road, Doomurjala, Howrah 711104, West Bengal, India |
| Type of Sponsor |
Government 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 |
| Shubhamoy Ghosh |
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal |
Dept. of Pathology & Microbiology, OPD 3, every Monday, 9 am to 2 pm, Drainage Canal Road, Doomurjala, Howrah 711104
Haora
WEST BENGAL |
9831034229
shubhamoy67@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Mahesh Bhattacharyya Homoeopathic Medical College Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Anal fissure, (1) ICD-10 Condition: K602||Anal fissure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homeopathic
medicine in centesimal potencies plus general management |
Each dose shall consist of 4 cane sugar globules medicated with a single drop of the indicated medicine, preserved in 88% v/v ethanol. Repetition 24, 12 or 8 hourly or even oftener,
depending upon the individual requirement of the case. Each dose to be taken orally on clean
tongue in empty stomach.
Duration of therapy: 3 months.
General management: Sitz bath twice a day regularly, maintain local hygiene, correct constipation and unhealthy defecation habits, to avoid straining at stool, and to exercise regularly |
| Comparator Agent |
Placebo |
Each dose consists of 4
cane sugar globules no. 30
moistened with a single drop of non-medicated rectified spirit; indistinguishable
from verum. To be taken thrice a day orally on clean tongue in empty stomach. Duration of therapy: 3 months.
General management: Sitz bath twice a day regularly, maintain local hygiene, correct constipation and unhealthy defecation habits, to avoid straining at stool, and to exercise regularly |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Cases suffering from anal fissure
2.Both male and female patients
3.Age between 18 and 65 years
4.Patients with known but controlled systemic diseases
5.Patients using topical agents for anal fissure will be included after a washout period of one week, subject to persistence of symptoms and signs of fissures
6.Patients giving written consent to participate |
|
| ExclusionCriteria |
| Details |
1.Cases suffering from uncontrolled systemic illness or life-threatening infections
2.Cases already undergoing homoeopathic treatment elsewhere for any chronic purpose
3.Substance abuse and/or dependence
4.Previous history of surgical interventions for anal fissure
5.Diagnosed or suspected cases of rectal malignancies
6.Pregnancy and lactation
7.Patients with psychiatric diseases |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numeric rating scales (NRS; 0-10) measuring intensity of pain [0: no pain; 10: worst possible pain] |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Translated Bengali version of the Gastrointestinal Quality of Life Index (GQLI) questionnaire |
3 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/09/2017 |
| Date of Study Completion (India) |
28/11/2018 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Anal fissure is one of the most frequent and painful anal
diseases. It is very painful, because it affects the multilayer squamous
epithelium of the anoderm, which is richly innervated with pain fibers. During
defecation, the lesion is stretched with consequent painful symptomatology,
which can persist for a certain amount of time and be accompanied by slight
bleeding. The pain can be so intense as to induce the
patient to avoid defecation with consequent hardening of the faeces and
exacerbation of the problem. It is associated with spasm of the internal anal
sphincter which may lead to reduction of blood flow and delayed healing. The pain characteristics of anal fissure is
intense burning pain that appears immediately or later after evacuation of the
bowels, of variable duration, described as passing a ‘‘razor blade’’ or
‘‘broken glass’’. Anal fissures are not common in patients older
than 65 years, and in this age group must be suspected to be associated with
other pathologies. The lifetime incidence is calculated to be 11%. The diagnosis is based on the presence of
intense pain, with possible bleeding, during or after defecation. Digital
exploration should be avoided – spasm and pain can make diagnosis impossible. Improving diet and defecation habits is a good
long-term strategy. Therefore, patients with primary chronic anal fissures are
advised to assume liquids and fibre supplements as well as bulk-forming
emollient laxatives and to use warm sitz baths. Clinical management of anal fissure is still
controversial. Inefficacy of medical therapies in many cases and in order to
avoid post-surgical complications, many a patients refer to CAM therapies. Homeopathy may have immense potential to offer
in successful treatment of anal fissure, but has remained seriously
under-researched till date. We intend to uptake a prospective, double-blind, randomized, parallel
arm, placebo-controlled, clinical trial testing efficacy of individualized homeopathic treatment of anal fissure. As per eligibility criteria, 150 patients will be enrolled in the trial from the outpatients or inpatients of Mahesh
Bhattacharyya Homoeopathic Medical College & Hospital. Patients will be randomized to receive either individualized homeopathy medicines or indistinguishable placebo. All the
participants will be encouraged to have sitz bath twice a day regularly,
maintain local hygiene, correct constipation, consume adequate water, and correct unhealthy defecation habits. Outcome data, in terms of pain 0-10 numeric rating scale and patient-administered translated Bengali version of the
Gastrointestinal Quality of Life Index (GQLI) questionnaire will be obtained at baseline and after 3 months. Collected data will be analyzed statistically and will be published in scientific journals. |