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CTRI Number  CTRI/2025/10/096273 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 17/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective case series study 
Study Design  Single Arm Study 
Public Title of Study   To study the role of miasm in homoeopathic management of grade-I and grade-II hemorrhoids  
Scientific Title of Study   To explore the role of miasms in homoeopathic management of grade-I and grade-II hemorrhoids in age group 25-60 years- A prospective case series study. 
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 Latika Wagh 
Designation  PG Student 
Affiliation  Smt. K.B.Abad Homoeopathic Medical college, Chandwad 
Address  Smt.K.B.Abad Homoeopathic Medical College Bhamshah shree V.D.Mehta Dev Vijay P.G.Institute of Homoeopathy. Neminagar chandwad

Nashik
MAHARASHTRA
423101
India 
Phone  9359348152  
Fax    
Email  latika16728@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S P Tripathi 
Designation  Associate Professor 
Affiliation  Smt. K.B.Abad Homoeopathic medical college chandwad 
Address  Smt.K.B.Abad Homoeopathic Medical College Bhamshah shree V.D.Mehta Dev Vijay P.G.Institute of Homoeopathy. Neminagar chandwad

Nashik
MAHARASHTRA
423101
India 
Phone  9765310371  
Fax    
Email  shatrughantrpth4@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ajay Dahad 
Designation  Principal 
Affiliation  Smt. K.B.Abad Homoeopathic medical college chandwad 
Address  Smt.K.B.Abad Homoeopathic Medical College Bhamshah shree V.D.Mehta Dev Vijay P.G.Institute of Homoeopathy. Neminagar chandwad

Nashik
MAHARASHTRA
423101
India 
Phone  9423929797  
Fax    
Email  drdahad@yahoo.com  
 
Source of Monetary or Material Support  
Smt K.B.Abad Homoeopathic Medical College Chandwad 423101 Maharashtra India 
 
Primary Sponsor  
Name  Dr Latika wagh 
Address  Smt K.B.Abad Homoeopathic Medical college chandwad 423101 
Type of Sponsor  Other [self sponsored] 
 
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 Latika wagh  Smt.K.B.Abad Homoeopathic Medical College chandwad  Surgery OPD Smt.K.B.Abad Homoeopathic Medical College Bhamshah shree V.D.Mehta Dev Vijay P.G.Institute of Homoeopathy. Neminagar chandwad 423101
Nashik
MAHARASHTRA 
9359348152

latika16728@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Smt.K.B.Abad Homoeopathic Medical College Bhamshah shree V.D.Mehta Dev Vijay P.G.Institute of Homoeopathy. Neminagar chandwad 423101  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K641||Second degree hemorrhoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients suffering from grade I and grade II hemorrhoids presenting with any of the symptoms bleeding pain tenesmus heaviness pruritus mucus discharge from anorectal region
2.Diagnosed cases of hemorrhoids taking treatment from other system of medicine but feeling no relief and now willing to take homoeopathic treatment
3.Age group 25 To 60 years
4.Patients from various socioeconomic status
5.Patients with Hb count less than 8 gm per dl
6.Patients with signed written consent  
 
ExclusionCriteria 
Details  1.Patients suffering from grade III and grade IV hemorrhoids
2.Age group less than 25 years and more than 60 years
3.Patients with associated comorbidities like fissures fistula anal stricture and other systemic disorders like known bleeding disorders diabetes mellitus and hypertension
4.Patients with Hb count more than 8 gm per dl
5.Pregnant females 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual analogue scale is used to measure the severity of hemorrhoid symptoms before and after treatment
1.Improved
2.Not improved  
1.Duration of study-18 months
2.Duration of each case- Each case will be studied for 6 months or till recovery occurs, whichever is earlier
3.Duration of follow up- As per requirement and severity of case
4.Clinical outcome assessment will be done at baseline of 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   28/10/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

INTRODUCTION

        Hemorrhoids or piles is a anorectal disease associated with sedentary lifestyle. It commonly occurs due to varicosities of hemorrhoidal veins. Internal hemorrhoids and external hemorrhoids are two types of hemorrhoids. Hemorrhoids are more commonly observed in the adult population. Adults from age group 45 to 60 are more prone to suffer hence in this study a wide range is targeted to see the predominant age group likely to suffer and aim of this study is to acknowledge the prevalence depending upon gradation of hemorrhoids.

      It is necessary to study homoeopathic management of hemorrhoids as other schools of medicine treating this condition with medication, topical ointments and surgery which only suppress or palliate the disease state, that later on followed by relapse or worse disease manifestation or often leading to recurrence with more severe symptom and many patients suffer from post operative complications .

     In homoeopathy we believe that to treat disease, root cause should be removed. Dr. Hahnemann explains in aphorism 80 that the psora, is the only real fundamental cause of various diseases like nervous debility, hysteria, hypochondriasis, mania, melancholia, epilepsy, convulsions, gout, hemorrhoids, cancer, deafness, cataract etc. 

      Although remarkable cure is noticed in hemorrhoids cases, research evidences are too much compromised regarding susceptibility, miasm, posology in such cases hence the present study is aimed at investigating the role of miasms in homoeopathic management of grade I and grade II hemorrhoids as a conservative treatment method.

 

AIM AND OBJECTIVE

 

PRIMARY OBJECTIVE

 To explore the role of miasm in homoeopathic management of grade I and grade II hemorrhoids. 

 

OTHER OBJECTIVE

 1.To study the susceptibility in cases of grade I and grade II hemorrhoids. 

 2.To understand the importance of posology in cases of grade I and grade II hemorrhoids.

 

METHODOLOGY

 

1.STUDY DESIGN  A Prospective case series study. 

 

2.STUDY SETTING 

a. Cases are collected from OPD and IPD of homoeopathic medical college. 

b. Peripheral OPDs run by the homoeopathic medical college. 

c. Medical camps conducted by the institute. 

 

 3.STUDY POPULATION

 Patients from various socioeconomic status, suffering from grade I and grade II hemorrhoids in the age group 25 to 60 years. 

 

 4.DURATION OF STUDY 

18 months during the MD course . Follow up will be done as per the requirement of a case and severity of symptoms. 

 

 5.METHOD OF SELECTION OF STUDY SUBJECT  

 INCLUSION CRITERIA 

 1. Patients suffering from grade I and grade II hemorrhoids presenting with any of the symptoms bleeding, pain, tenesmus, heaviness, pruritus, mucus discharge from anorectal region.

 2. Diagnosed cases of hemorrhoids taking treatment from other system of medicine but feeling no relief and now willing to take homoeopathic treatment. 

 3. Age group 25 to 60 years. 

 4. Patients from various socioeconomic status. 

 5. Patients with Hb count more than 8 gm per dl. 

 6. Patients with signed written consent  

 

EXCLUSION CRITERIA

 1. Patients suffering from grade III and grade IV hemorrhoids. 

 2. Age group less than 25 years and more than 60 years. 

 3. Patients with associated comorbidities like fissures, fistula, anal stricture and other systemic disorders like known bleeding disorders, diabetes mellitus and hypertension. 

 4. Patients with Hb count less than 8 gm per dl. 

 5. Pregnant females. 

 

 SUBJECT WITHDRAWL CRITERIA 

 1. Cases with irregular follow ups. 

 2. Patient who are on Parallel treatment for the same/other Disease. 

 3. Patient who are not following protocol. 

 4. Disease progressing even after receiving treatment for more than 6 months, such patients will be excluded. 

 5. Patients with Hb count less than 8 gm per dl. 

 

 6.OPERATIONAL DEFINITION 

 Hemorrhoid is a swollen and painful area located at or near the anus. 

 Miasm means the fundamental cause of disease.

 

 7.SPECIFICATION OF INSTRUMENT AND RELATED MEASUREMENT 

 Visual analogue scale is used to measure the severity of hemorrhoid symptoms before and after treatment. 

 Improved is complete relief of signs and symptoms and general well being of the patient. 

 Not improved is no relief of complaints after sufficient period of treatment.

 

SAMPLE SIZE

Minimum 30 cases

 

SAMPLING TECHNIQUE

Simple random sampling.

 

DATA MANAGEMENT AND ANALYSIS PROCEDURE

1.Data for case taking will be collected from patient, patients attendants, physicians observations and examination finding. 

2.Symptoms of the case will be repertorized using synthesis repertory from RADAR software.

3.Depend upon totality of symptoms, homoeopathic similimum will be given 

4.Pre and post symptom severity score will be maintained in case record form and excel sheet. 

5.The analysis of the collected data will be done as per appropriate statistical test to assess the effectiveness of homoeopathic intervention.


 
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