| CTRI Number |
CTRI/2025/02/080880 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role Of Homoeopathic Medicine In The Treatment Of Haemorrhoids. |
|
Scientific Title of Study
|
A Clinical Study On Individualized Homoeopathic Medicine In The Treatment Of Haemorrhoids By Using O.E. Boericke’S Repertory |
| 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 Shivangi Kumari |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital, Lucknow |
| Address |
Department of case taking and Homoeopathic repertory, OPD-12,State National Homoeopathic Medical College and Hospital, 1 Viraj Khand , Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8010226130 |
| Fax |
|
| Email |
gazalk96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupesh Kumar Pandey |
| Designation |
Lecturer |
| Affiliation |
State National Homoeopathic Medical College and Hospital, 1 Viraj Khand , Gomti Nagar, Lucknow |
| Address |
Department of Homoeopathic Pharmacy,State National Homoeopathic Medical College and Hospital, 1 Viraj Khand , Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9455577528 |
| Fax |
|
| Email |
drrupeshkumarpandey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivangi Kumari |
| Designation |
Post Graduate Trainee |
| Affiliation |
State National Homoeopathic Medical College and Hospital, 1 Viraj Khand , Gomti Nagar, Lucknow |
| Address |
Department of case taking and Homoeopathic repertory,OPD-12, State National Homoeopathic Medical College and Hospital, 1 Viraj Khand , Gomti Nagar, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8010226130 |
| Fax |
|
| Email |
gazalk96@gmail.com |
|
|
Source of Monetary or Material Support
|
| State National Homoeopathic Medical College And Hospital, 1- Viraj Khand, Gomti Nagar , Lucknow- 226010 , Uttar Pradesh, India. |
|
|
Primary Sponsor
|
| Name |
Dr. Shivangi Kumari |
| Address |
Department of case taking and Homoeopathic Repertory, State National Homoeopathic Medical College And Hospital, 1- Viraj Khand, Gomti Nagar, Lucknow , Uttar Pradesh-226010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shivangi Kumari |
State National Homoeopathic Medical College And Hospital, 1 Viraj khand , Gomti Nagar, Lucknow |
Department of Case Taking and Homoeopathic Repertory, OPD-12, Gomti Nagar, Lucknow, Uttar Pradesh-226010
Lucknow
UTTAR PRADESH |
8010226130
gazalk96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethical Committee State National Homoeopathic Medical College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K648||Other hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine Using O.E. BOERICKE Repertory |
Intervention- Individualized Homoeopathic Medicine Using O.E. BOERICKE Repertory. Patients qualifying to inclusion criteria will be included in the study. Proper case taking of all enrolled patients will be done in standardized case taking proforma which is being used in State National Homoeopathic medical college and hospital. Homoeopathic medicines will be prescribed to all patients after analysis and evaluation of symptoms and proper repertorization using O.E. BOERICKE Repertory. Indicated homoeopathic remedy will be administered as decided appropriate to the case or condition in appropriate potency and doses. Medicines will be given oral route in 30C/200C/1M/10M potency as per requirement of the case. Each case will be followed up at regular interval preferably at a period of 15 days or as per requirement. Patient will be studied for 6 months after enrolment in study. Outcome assessment of the patients will be carried out after 6 months of homoeopathic medication based on ARSSQoL and ARSSQoL-NRS Questionnaire at the end of 6 months. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Patients having clinical signs and symptoms of haemorrhoids namely, rectal bleeding and discomfort or irritation, a protruding mass, Blood after defaecation, Pain with something coming out with bleeding, Pruritus from mucous discharge, heaviness, tenesmus during defaecation
- Pre diagnosed cases of haemorrhoids. Proctoscopy, if necessary
-Patients having no other complicated systemic illness
-In cases, where patients are already taking homeopathic medicine for haemorrhoids will be taken up for studies only after a wash out period of two weeks
-Patients giving written consent to participate in the study |
|
| ExclusionCriteria |
| Details |
• Pre diagnosed case of rectal malignancies, fistula, rectal polyps, anal fissure, irritable bowel syndrome.
• Cases already taking homoeopathic treatment for any other systemic illness.
• Patient who were not willing to come for follow up.
• Patients having any serious medical illness.
• Pregnant woman and lactating mothers.
• Grade IV piles
• Coagulation disorders
• Patients on allopathic drugs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Utility of O.E. BOERICKE Repertory to select Individualized Homoeopathic medicine in the treatment of Haemorrhoids. |
12 weeks to 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The study will determine changes in the quality of life of patients suffering from
haemorrhoids. |
12 weeks to 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/03/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an prospective, single arm clinical study which aims to access the utility of O.E. BOERICKE repertory in the treatment of Haemorrhoids. Outcome assessment of the patients will be carried out after 6 months of homoeopathic medication based on.ARSSQoL and ARSSQoL- NRS score will be calculated pre and post-treatment and the difference will be compared and analysed.
Haemorrhoids or Piles are naturally occurring vascular tissues in the anal canal that can become engorged and prolapsed due to straining, leading to symptoms such as pain, swelling and bleeding, These can be classified as internal or external haemorrhoids, with the latter being more painful when thrombosed. Haemorrhoids are common globally, with a higher prevalence in India (around 40 million cases). While haemorrhoids are usually benign , if untreated, they can worsen and potentially indicate more serious underlying issues. Homoeopathy offers holistic approach to treatment, focusing on the individual’s overall health and underlying factors rather than just local symptoms of disease. By treating the person ass a whole, homoeopathic remedies aim to gently address haemorrhoids. This study aims to explore the role of individualized homoeopathic medicines in their management of haemorrhoids by using O.E. BOERICKE repertory and to determine changes in the quality of life of patients suffering from haemorrhoids. |