| CTRI Number |
CTRI/2024/11/077014 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Other (Specify) [Therapeutic and research] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathic treatment of Anal fissure |
|
Scientific Title of Study
|
Uility of Individualized Homoeopathic Medicine in 50-millesimal potencies in the
management of Anal Fissure: A Pretest-Posttest Interventional Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swapan Paul |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
Block - GE, Sector - III, Salt Lake, Kolkata - 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9830148968 |
| Fax |
|
| Email |
drspaul.2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapan Paul |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
Block - GE, Sector - III, Salt Lake, Kolkata - 700106
WEST BENGAL
700106
India |
| Phone |
9830148968 |
| Fax |
|
| Email |
drspaul.2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajib Purkait |
| Designation |
Research Associate |
| Affiliation |
National Institute of Homoeopathy |
| Address |
National Institute of Homoeopathy
Block - GE, Sector - III, Salt Lake, Kolkata - 700106
North Twentyfour Parganas
WEST BENGAL
700106
India |
| Phone |
9748925539 |
| Fax |
|
| Email |
rajibpurkait20@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Block - GE, Sector - III, Salt Lake, Kolkata - 700106, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block - GE, Sector - III,
Salt Lake, Kolkata - 700106 |
| 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 |
| Dr Swapan Paul |
National Institute of Homoeopathy |
OPD No.18, Dept. of Materia Medica, National Institute of Homoeopathy,
Block - GE, Sector - III,
Salt Lake, Kolkata - 700106, West Bengal, India.
North Twentyfour Parganas
WEST BENGAL |
9830148968
drspaul.2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute of Homoeopathy |
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 |
Individualized Homoeopathic medicine. |
Individualized homoeopathic medicine is known and safe for use. The medicines will be administered orally. Medicines will be selected as per the symptomatology of the patient. All the medicines will be prescribed in 50-millesimal potencies. Medicine will be dispensed by taking 2 medicated poppy seed-like globules (no. 10) mixed in 100 ml of distilled water in addition to 1 ml of rectified spirit then giving 10 succussions and making 16 doses. Each dose consists of 6 ml.
Doses and repetition will be as per homoeopathic principles.
Duration of intervention: 3 months for each individual case. |
| Comparator Agent |
Not applicable |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
i. Age:18 - 65 years.
ii. Gender: Both Male and Female.
iii. Diagnosed cases of Anal Fissure
iv. Patients using topical agents for fissure will be included after a washout period of two weeks, subject to persistence of symptoms and signs of fissures
v. Patient voluntarily giving written informed consent for the study.
|
|
| ExclusionCriteria |
| Details |
i. Severe co-morbidities or any other uncontrolled systemic diseases, life-threatening illness etc. affecting Quality of Life.
ii. Pregnant or breast-feeding women.
iii. Substance abuse and/ or dependence.
iv. Psychologically unstable patients.
v. Previous history of surgical interventions for anal fissure.
vi. Diagnosed or any suspected cases of rectal malignancies
vii. Under-going homoeopathic treatment for any chronic diseases for last 3 months.
viii. Patients who are unable to read the patient information sheet and written consent form.
ix. Patient unwilling to take part in the study and not giving written consent for this study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical pain rating scale (0-10). |
Baseline and after 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| HEMO-FISS scale |
Baseline and after 3 months. |
| Modified Naranjo Criteria for Homoeopathy (MONARCH) |
After 3 months of treatment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/11/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anal fissure is one of the most prevalent anorectal illnesses; it is caused by a longitudinal tear in the anoderm beneath the dentate line. Defecation is painful, and there is constant bleeding. The majority of fissures are treated conservatively, however a significant percentage become chronic and have a detrimental effect on the patient’s general quality of life. Among the complementary and alternative medicine (CAM), Homoeopathy is one of the non-invasive therapeutic option for the management of ano-rectal disorders. Homoeopathy have the evidences in favour of anorectal disorders. In homoeopathic perspective, the treatment of patient is mainly based on individualization. All the patients have to enquire as a whole. Homoeopathy not only manages fissures, it also prevents relapses. Homoeopathic literatures are lacking the evidences in anal fissures; it has not been researched systematically. Even there are no studies using 50 millesimal potencies in the managing anal fissures. Fifty millesimal potencies having some evidences in treating acute or chronic diseases in its favour.Therefore the investigator aims to evaluate the utility of individualized homoeopathic medicine in 50-millesimal potencies in the management of anal fissure. The medicine are will be administered orally, and it is safe for use in humans. All the medicines will be prescribed in 50-millesimal potencies.Doses and repetition will be as per homoeopathic principles. The outcomes will be Numerical pain rating scale (0-10), HEMO-FISS score, will be measured at baseline ans after 3 months of treatment. the likelihood of improvement will be assessed by Modified Naranjo Criteria for Homoeopathy (MONARCH) score. Duration of therapy: 3 months for each individual case.
|