| CTRI Number |
CTRI/2024/12/078125 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of haemorrhoids with Homoeopathic Remedies selected by synthesis repertory |
|
Scientific Title of Study
|
Management of Haemorrhoids using homoeopathic medicines utilizing Essential synthesis repertory& Preparation of Repertory of Haemorrhoids and therapeutics for the same |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhara Bharatbhai Kothari |
| Designation |
P G Scholar |
| Affiliation |
Rajkot homoeopathic medical college. |
| Address |
Department of Case taking and Repertory, Rajkot Homoeopathic Medical College , Behind Jainath Complex , Makkam chowk, Gondal Road ,Rajkot -360002
Rajkot
GUJARAT
360002
India |
| Phone |
9426943067 |
| Fax |
|
| Email |
dharaddoshi81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kashyap R Premsawala |
| Designation |
HOD / professor |
| Affiliation |
Rajkot homoeopathic medical college |
| Address |
Department of Case taking and Repertory, Rajkot Homoeopathic Medical College , Behind Jainath Complex , Makkam chowk, Gondal Road ,Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9727173799 |
| Fax |
|
| Email |
k2krp@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhara Bharatbhai Kothari |
| Designation |
P G Scholar |
| Affiliation |
rajkot homoeopathic medical college |
| Address |
Department of Case taking and Repertory, Rajkot Homoeopathic Medical College , Behind Jainath Complex , Makkam chowk, Gondal Road ,Rajkot -360002
Rajkot
GUJARAT
360002
India |
| Phone |
9426943067 |
| Fax |
|
| Email |
dharaddoshi81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot homoeopathic medical college , behind jainath complex , makkamchowk gondal road ,Rajkot -360002 ,Gujrat , India |
|
|
Primary Sponsor
|
| Name |
Rajkot homoeopathc medical college |
| Address |
Behind jainath complex makkam chowk. Rajkot ,360002 ,Gujrat . 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 Dhara B Kothari |
Sainath homoeopathic hospital atteched with Rajkot homoeopathic medical college. |
Department of case taking and repertory ,Rajkot homoeopathc medical college, Behind jainath complex ,makkam chowk - Rajkot.360002, Gujrat , India
Rajkot
GUJARAT |
9426943067
dharaddoshi81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research- Rajkot homoeopathic medical college(RHMC) Parul university ,Gujrat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homoeopathic medicines |
Individualised homoeopathic medicines selected by using synthesis repertory will be prescribed in 30,200,and 1 M potencies through oral sub lingual route . The selection of doses and repetition will be selected according to susceptibility of patients and principles of organon of medicine. Medicine will be administered by oral sublingual route and re - assessment will be done after 2 weeks. The final assessment of study will be done after 9 months |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both sexes & age group between 20-60 years will be considered.
All socio-economical classes will be considered.
Pre-diagnosed cases which are under any system of treatment, but yet not having relief or improvement & willing to take homoeopathy
|
|
| ExclusionCriteria |
| Details |
Complicated cases with advanced & irreversible pathological conditions.
Cases with irregular follow-ups.
Pregnancy leading to obstruction of the portal circulation, lactating mothers, patients with psychiatric diseases.
chronic alcoholism
patient on anticoagulants
patient infected with HIV
heamorrhoids in children
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patients of hemorrhoids will be benefited by medicines selected using synthesis repertory. |
Patients of hemorrhoids will be benefited by medicines selected using synthesis repertory. This outcome will be achieved in period of 9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) None :- Note sever
b) Mild Improved:- Mild , easily tolerable
c) Moderate improvement:- Moderate , Interferes with tasks
d) Moderate improvement :- Interferes with concentration
e) Severe :- Synmptoms are intolerable ,interferes with basic needs.
f) Worst possibility:- Needs bedrest
|
a) None :- Note sever
b) Mild Improved:- Mild , easily tolerable
c) Moderate improvement:- Moderate , Interferes with tasks
d) Moderate improvement :- Interferes with concentration
e) Severe :- Synmptoms are intolerable ,interferes with basic needs.
f) Worst possibility:- Needs bedrest
These goals will be achieved in the period of 9 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/12/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Haemorrhoids have been a nuisance since down
of a man.Very common burning problems in many individuals nowadays. Haemorrhoids are embrassing to talk about,
but as a physician we have to help such individuals to find relief .
As a physician we come in contact with many diseases which are occurring
due to venous insufficiencies. The most common among them are “Varicose veinsâ€
& “Haemorrhoidsâ€. They are inflamed or swollen veins in the rectum or anus.
Haemorrhoids are most common conditions whose first reference was
written centuries ago to the earliest civilizations, including the Egyptians,
the greek & the romans, the word “haemorrhoids†has greek roots haema
(Blood) & rhoos coined by Hippocrates in 460 BC. The first known mention of this disease is from a 1700 BCE
Egyptian papyrus[9]
It is also described in bible"emerods".[10]
Hemorrhoids are
vascular structures in the anal canal . In
their normal state they are cushions that help with stool control.[11] They
become a disease when it get swollen or inflamed.
The epidemiology of heamorrhoids in
india according to recent survey is around 75 % of population[12].
Hemorrhoids have a number of causes,
but often the cause is unknown.
Fortunately,
effective options are available to treat hemorrhoids. Many people get relief with
home treatments and lifestyle changes. Dissatisfaction with allopathic treatment is often the reason
behind seeking homoeopathic treatment.
It is observed that nearly
three out of four adults suffer from hemorrhoids at any part of life time and
this makes me interested in study of homoeopathic approach for the
heamorrhoids. As the “Holistic integrated, non – aggressive approach “ of
homoeopathy leads to positive results.
For the present study I
have selected latest edition of Essential synthesis repertory book version
because it is morden ,practicle n enriched with many clinical n pathological
rubrics. Derived
from the RADAR software, contains many additions from varied sources. |