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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  
Name  Address 
nil  nil 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [210409201002@paruluniversity.ac.in].

  6. 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.

  7. 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 likes”.

 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.

 
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