| CTRI Number |
CTRI/2024/11/076727 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing the Effectiveness of the Homoeopathic Medicines in Managing Hemorrhoids |
|
Scientific Title of Study
|
The Effectiveness of Homoeopathic Medicines in the Management of Hemorrhoids using Homoeopathic Medical Repertory with Assessing Quality of Life |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PANDITI JEEVAN CHAND |
| Designation |
PG SCHOLAR |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory OPD Room No 3C Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO Salem
Salem
TAMIL NADU
636308
India |
| Phone |
8498937045 |
| Fax |
|
| Email |
jeevanjc646@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D ESTHER DEVA RAMYA |
| Designation |
HEAD OF THE DEPARTMENT OF REPERTORY |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory OPD Room No 3C Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9865191996 |
| Fax |
|
| Email |
estherdevaramya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D ESTHER DEVA RAMYA |
| Designation |
HEAD OF THE DEPARTMENT OF REPERTORY |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Repertory OPD Room No 3C Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9865191996 |
| Fax |
|
| Email |
estherdevaramya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO Salem TAMILNADU 636308 India |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
NH 47 Sankari Main Road Seeragapadi PO Salem TAMIL NADU 636308 India |
| 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 PANDITI JEEVAN CHAND |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Department of Repertory OPD Room No 3C Ground Floor Hospital Block Vinayaka Missions Homoeopathic Medical College and Hospital NH 47 Sankari Main Road Seeragapadi PO Salem TAMIL NADU 636308 India
Salem
TAMIL NADU |
8498937045
jeevanjc646@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Vinayaka Missions Kirupananda Variyar Medical College and Hospital Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K649||Unspecified hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Suitable Homoeopathic medicines are selected based on individulaization of the patient. Based on susceptibility of the patient the dose is selected. Medicine is administered via oral route. Follow up is taken once in every one month |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Hemorrhoids based on clinical history and findings. Patients with first three grades of Hemorrhoids |
|
| ExclusionCriteria |
| Details |
patients with fourth grade of hemorrhoids. Patients suffering from life threatening conditions. Patients require emergency medical intervention |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of Homoeopathic medicines from the Homoeopathic medical
repertory for Hemorrhoids by using the Hemorrhoidal Disease Symptom Score |
At baseline and at the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of patinet with Hemorrhoids is done based upon quality of life using Short Health Scale |
At baseline and at the end of study |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="37" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/12/2024 |
| Date of Study Completion (India) |
16/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Hemorrhoids means bleeding(haema means blood; rhoos means flowing). The term Pile is derived from the Latin word Pila meaning ball and referring to the glandular swelling of the pile mass. Hemorrhoids are a common anorectal condition defined as the symptomatic enlargement and distal placement of the normal anal cushions. They affect millions of people around the world and represent a major medical and socioeconomic problem. Multiple factors have been claimed to be the etiologies of hemorrhoidal development, including constipation and prolonged straining. The abnormal dilation and distortion of the vascular channel, together with destructive changes in the supporting connective tissue within the anal cushion, is a paramount finding of hemorrhoidal disease. A positive diagnosis is based on Proctoscopic examination. The effectiveness of Homoeopathic medicine for severity management using Hemorrhoids Severity Score. Assessment of quality of life is aimed at displaying the efficacy of Homoeopathic medicine in managing hemorrhoids using the Short Health Scale. The Homoeopathic treatment is based on a totality of symptoms which is obtained from individualizing the case and finding out the cause and characteristic of the person since hemorrhoids cause pain, bleeding, itching, and a lot of clinical symptoms. The Homoeopathic
medical repertory is selected which fulfills, the requirement of ailments from modifying
symptoms, concomitants, and clinical symptoms. |