| CTRI Number |
CTRI/2024/12/077517 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of homoeopathic medicine in managing pain of anal fissure |
|
Scientific Title of Study
|
Assessing the effectiveness of homoeopathic medicine in managing pain of anal fissure among adults - A prospective, pre-post clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shinde Shubham Sambhaji |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine
Basement
B 16 and 17
Bakson Homoeopathic Medical College and Hospital
B 36 Knowledge Park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8862062819 |
| Fax |
|
| Email |
drshubham1010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akshay Mathur |
| Designation |
Guide and Head of Department |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine
Basement
B 16 and 17
Bakson Homoeopathic Medical College and Hospital
B 36 Knowledge Park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9868121727 |
| Fax |
|
| Email |
drakshaymathur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Mathur |
| Designation |
Guide and Head of Department |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine
Basement
B 16 and 17
Bakson Homoeopathic Medical College and Hospital
B 36 Knowledge Park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9868121727 |
| Fax |
|
| Email |
drakshaymathur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital 36 B Knowledge Park 1 Greater Noida |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No G22 Ground Floor Principal Office Bakson Homoeopathic Medical College and Hospital 36 B Knowledge Park 1 Greater Noida Gautam Buddha Nagar |
| 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 Shinde Shubham Sambhaji |
Bakson Homoeopathic Medical College and Hospital |
Peripheral Out Patient Department Main Market Road Malakpur Village and Out Patient Department Bakson Homoeopathic Medical College and Hospital 36B Knowledge Park 1 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
8862062819
drshubham1010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bakson Institutional Ethics Committee |
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 |
Homoeopathic Medicine |
Pill form
30 Pill size
Oral route of administration
Centesimal scale
First dose at the time of case taking
Subsequent doses according to follow up
follow up for a period of 6 months |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Participants in the age group 18-59 years and all genders
Participants clinically diagnosed with anal fissures
Participants willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
Individuals with severe complications like abscess fistula etc
Any severe systemic illness and immunocompromised individuals
Pregnant and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that there will be reduction in the pain of anal fissure compared to the baseline and improvement in their quality of life
|
15 months study
6 months enrollment
6 months follow up
3 months data analysis
VAS Scale and ORIDL Scale will be assessed at the baseline and after 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
12/12/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study is to evaluate the effect of homoeopathic medicines to manage pain and improve the quality of life in adults with anal fissure Sample size 35 Prospective pre post clinical study 15 months study Scale used for assessment are VAS scale and ORIDL scale Baseline score and final score at the end of treatment will be used for final assessment It is expected to see reduction in pain of anal fissure and improvement in their quality of life
|