| CTRI Number |
CTRI/2024/05/068100 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Utility of homoeopathic medicine in piles cases
Utility of Homoeopathic medicine in Piles Cases
|
|
Scientific Title of Study
|
Role of individualized Homoeopathic medicine in management of 1st and 2nd degree piles assessed with CORECT scale- prospective clinical trial |
| 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 Anjali Gupta |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College, Parul University |
| Address |
Department of Materia Medica, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chok, Gondal Road, Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
8160388675 |
| Fax |
|
| Email |
210409201002@paruluniversity.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vani Oza |
| Designation |
HOD/Associate Professor |
| Affiliation |
Rajkot Homoeopathic Medical College, Parul University |
| Address |
Department of Materia Medica, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chok, Gondal Road, Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
9428052673 |
| Fax |
|
| Email |
vanioza8@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vani Oza |
| Designation |
HOD/Associate Professor |
| Affiliation |
Rajkot Homoeopathic Medical College, Parul University |
| Address |
Department of Materia Medica, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chok, Gondal Road, Rajkot
Rajkot GUJARAT 360002 India |
| Phone |
9428052673 |
| Fax |
|
| Email |
vanioza8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College, Rajkot, Gujarat,360002 |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical College Rajkot Gujarat |
| Address |
Department of Materia Medica,Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chok, Gondal Road, Rajkot, Gujarat,360002 |
| 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 Anjali Gupta |
Sainath Homoeopathic Hospital, Rajkot Homoeopathic Medical College, Parul University |
Department of Materia Medica,Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chok, Gondal Road, Rajkot Rajkot GUJARAT |
8160388675
210409201002@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research - Rajkot homeopathic Medical College Parul University, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K640||First degree hemorrhoids, (2) ICD-10 Condition: K641||Second degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine |
mode of administeration - oral route
potency - 30, 200, 1m, 10m
frequency - every week
continuation till improvement is seen |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed case of piles
2. patient willing to opt homoeopathic treatment
3. patient suffering from 1st and 2nd degree piles |
|
| ExclusionCriteria |
| Details |
Patient having complications of piles
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study role of Individualises homoeopathic Medicine in Management of haemorrhoids
1st and 2nd degree.
|
every 8 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Clinical verification of symptoms of medicine of similimum to individual.
2 To ascertain disease symptoms of medicine.
|
it will be also achieved with primary outcome within 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)
|
31/05/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [210409201002@paruluniversity.ac.in].
- For how long will this data be available start date provided 01-06-2024 and end date provided 01-05-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
|
Haemorrhoids are a disease whichn
challenges the modern treatment namely local Medication and surgical removal.
Aconsiderable part of population suffers from this disease with bleeding,
pain, itching, prolapse or altered bowel habits. These causes extreme
inconvenience which hurdles and hinders the patient’s daily routine with
great mental agony and anxiety.
The
most common complication such as profuse haemorrage, strangulation,
thrombosis, ulceration, gangrene. In these cases, judicious prescribing of
homoeopathy can cure the condition and prevent surgeries.
Symptomatic haemorrhoids affect more than 1
milion individual in modern civilization per year. Prevalence of haemorrhoids
disease is not selective for age or sex it can Affect any age group. On
physical examination of all healthy people 2/3 are reported having
Haemorrhoids.
The
estimated worldwide prevalence of haemorrhoids is 4.4% globally various
studies Were conducted to assess the prevalence and associated factor of
haemorrhoids. The condition affect
39-52% of adults The prevalence of haemoeehoids is extremely high in western
and other industrialized societies, with millions affected worldwide. The
prevalence of haemorrhoids in india according to recent surveys is around 40
million.
Risk factor commonly associated with haemorrhoidal disease includen
low fiber diet, chronic constipation, and diarrhoea, straining during
defecation, pregnancy, sedentary life Style, obesity etc. Common symptoms include
pain, itching, swelling, anal discomfort, and rectal bleeding; all ofwhich
severely affect patient quality of life.
In
modern medicine Haemorrhoids treatment such as cauterization, Rubberband
ligation, freezing, sclerotherapy and stapled haemorrhoidopexy, which can
affect the patient daily routine.
In
case like haemorrhoids homoeopathy may prove better as compare to modern
medicine and even may improve the quality of life as a whole without masking
patient disease condition and also prevent relapse of it, even surgery unless
and until gross pathology and irreversive structural changes occurred.
Every science has certain basic guiding
principles. Homoeopathy as a science of medical treatment has a philosophy of
its own and its therapeutics is based on certain fundamental principles which
are quit distinct and different. which is discovered by Dr. Samuel Hahnemann
in 1796 which based on principle “SIMILIA SIMILIBUS CURENTUR†means “Let
likes be cured by likesâ€.
Dr. kent says: "Every symptom is
indicative of a deviation from the normal state of health".
According to Dr. Stuart Close:
"In general, a symptom is any evidence of disease, or change from a
state of health".
Dr.H. A Roberts says: "Symptoms
are the only representative expression of the diseased state"
Dr. Elizabeth Wright defies symptoms as:
"Symptoms, to the homoeopaths are the language of the body expressing
its disharmony and calling for the similar remedy".
According to Dr. Kent: It is a man
that is sick and to be restored to health, not his body, not the tissues.
I want to study
the affect of individual selected homoeopatic medicion on the bases of
Totality of symptom of patent in case of first and second degree of
haemorrhids.
|
|