| CTRI Number |
CTRI/2024/02/062236 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic medicines in the management of pain in the anus |
|
Scientific Title of Study
|
A Clinical study on the Homoeopathic Management of External
Haemorrhoids using VAS Scale |
| 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 Naveen Kumar S |
| Designation |
PG Scholor |
| Affiliation |
Vinayaka missions Homoeopathic Medical college and Hospital |
| Address |
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College
and Hospital Sankari Main Road NH 47
Chinnaseeragapadi PO
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College
and Hospital Sankari Main Road NH 47
Chinnaseeragapadi PO
Salem
TAMIL NADU
636308
India |
| Phone |
7010961957 |
| Fax |
|
| Email |
naveenkumardoc96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasath Rajan |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka missions Homoeopathic Medical college and Hospital |
| Address |
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College
and Hospital Sankari Main Road NH 47
Chinnaseeragapadi PO
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College
and Hospital Sankari Main Road NH 47
Chinnaseeragapadi PO
Salem
TAMIL NADU
636308
India |
| Phone |
7010217039 |
| Fax |
|
| Email |
drprasathrajanmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasath Rajan |
| Designation |
Assistant Professor |
| Affiliation |
Vinayaka missions Homoeopathic Medical college and Hospital |
| Address |
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College
and Hospital Sankari Main Road NH 47
Chinnaseeragapadi PO
Department of Homoeopathic Materia Medica
Vinayaka Missions Homoeopathic Medical College
and Hospital Sankari Main Road NH 47
Chinnaseeragapadi PO
TAMIL NADU
636308
India |
| Phone |
7010217039 |
| Fax |
|
| Email |
drprasathrajanmd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari main
Road,Chinnaseeragapadi PO, Salem, Tamil Nadu - 636308 |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Sankari Main Road NH 47 Chinnaseeragapadi Salem
|
| 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 |
| Naveen Kumar S |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Room No : 3 D - PG
Department of
Homoeopathic Materia
Medica OPD Medical
unit II, Ground floor,
Hospital block,
VMHMCH, NH47,
Sankari main road,
Chinnaseeragapadi PO
Salem
TAMIL NADU |
7010961957
naveenkumardoc96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K64||Hemorrhoids and perianal venous thrombosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicine |
Suitable Homoeopathic
Medicines will be selected
according to the case.Administration is through oral.Total duration of intervention is one year |
| Comparator Agent |
NIL |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age group from 18 to 60 years of age.
Both males and females are included in this study.
Diagnosed patients with external hemorrhoids.
Based on symptomatology and protoscopic evaluation will be done by co-guide from the surgery department and then patients will be included |
|
| ExclusionCriteria |
| Details |
People who are having associated other complaints especially rectal complaints like
recurrent Anal Abscess, Fissures and Fistulas, Prolapse of Rectum.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of Homoeopathic medicines in Haemorrhoids using vas scale |
At baseline and at the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NIL
|
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
23/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Haemorrhoids are dilated veins within the anal canal in the subepithelial region formed by
radicles of the superior, middle and inferior rectal veins.
Haemorrhoids are clearly divided into two categories – internal and external.
Internal Haemorrhoids means it is within the anal canal and internal to the orifice. It is
covered with mucus membrane and it is bright red or purple in colour. It usually commences at the
anorectal ring and ends at the dentate line.
External Haemorrhoids is situated outside the anal orifice and is covered by skin.
It may also be divided into primary and secondary. Secondary Haemorrhoids are secondary
to few conditions. The incidence of
piles apparently increases with age, and it seems likely that at least 50% of people over the age of
50 years having some form of Haemorrhoidal formation. However, the disease is by no means
confined to older individuals, and piles are encountered in people of all ages, including,
occasionally, young children. Men are seem to be affected roughly twice as frequently as women. |