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CTRI Number  CTRI/2026/04/109084 [Registered on: 22/04/2026] Trial Registered Prospectively
Last Modified On: 22/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare the effectiveness of Aesculus hippocastanum and Ratanhia peruviana mother tinctures in the homeopathic management of piles and anal diseases in adults aged 45 to 65 years. 
Scientific Title of Study   To Study the Role of Aesculus hippocastanum and Ratanhia peruviana Mother Tincture in Homoeopathy Management of Haemorrhoids and Ano-rectal Diseases in 45-65 Age Group An Experimental Comparative 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 Aparna Ravsaheb Birari  
Designation  PG Scholar 
Affiliation  Guru Mishri Homoeopathic Medical College and Hospital ,Shelgaon, Jalna 
Address  OPD NO.2, PHARMACY OPD,GURU MISHRI HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, SHELGAON, BADNAPUR, JALNA,MAHARASHTRA, INDIA. PINCODE 431202 Jalna MAHARASHTRA 431202 India
OPD NO.2, PHARMACY OPD,GURU MISHRI HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, SHELGAON, BADNAPUR, JALNA,MAHARASHTRA, INDIA. PINCODE 431202 Jalna MAHARASHTRA 431202 India
Jalna
MAHARASHTRA
431202
India 
Phone  7057941037  
Fax  02482262025  
Email  aparnabirari@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Smita Hiwrale 
Designation  PG Guide and Professor 
Affiliation  Guru Mishri Homoeopathic Medical College and Hospital, Shelgaon, Jalna 
Address  Department of Homoeopathic Pharmacy , Guru Mishri Homoeopathic Medical College and Hospital, Shelgaon, Badnapur, Jalna
Department of Homoeopathic Pharmacy , Guru Mishri Homoeopathic Medical College and Hospital, Shelgaon, Badnapur, Jalna
Jalna
MAHARASHTRA
431202
India 
Phone  9823117124  
Fax  02482262025  
Email  bsmita852@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Smita Hiwrale 
Designation  PG Guide and Professor 
Affiliation  Guru Mishri Homoeopathic Medical College and Hospital, Shelgaon, Jalna 
Address  Department of Homoeopathic Pharmacy , Guru Mishri Homoeopathic Medical College and Hospital, Shelgaon, Badnapur, Jalna
Department of Homoeopathic Pharmacy , Guru Mishri Homoeopathic Medical College and Hospital, Shelgaon, Badnapur, Jalna
Jalna
MAHARASHTRA
431202
India 
Phone  9823117124  
Fax  02482262025  
Email  bsmita852@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Aparna Ravsaheb Birari 
Address  Guru Mishri Homoeopathic Medical College and Hospital Shelgaon Badnapur Jalna Maharashtra India Pincode 431202  
Type of Sponsor  Other [self ] 
 
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 yogesh desarda   Guru Mishri Homoeopathic Medical College and Hospital  OPD No. 2, Pharmacy OPD, Guru Mishri Homoeopathic Medical College and Hospital, Shelgaon, Badnapur, Jalna, Maharashtra, India. Pincode 431202 Jalna, MAHARASHTRA
Jalna
MAHARASHTRA 		 8856828282
02482262025
pg@gurumishrihmc.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GMHMCIEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K642||Third degree hemorrhoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aesculus Hippocastanum Mother Tincture  Intervention Group A Patients will receive Aesculus hippocastanum mother tincture, 10–15 drops in half a cup of water, twice daily for 6–8 weeks, based on symptom similarity. Follow-up will be done every 2 weeks to assess clinical improvement  
Comparator Agent  Ratanhia Peruviana Mother Tincture  Comparator Group B Patients will receive Ratanhia peruviana mother tincture, 10–15 drops in half a cup of water, twice daily for 6–8 weeks, according to symptom presentation. Follow-up will be conducted every 2 weeks to evaluate response to treatment  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Individuals who have been clinically confirmed to be suffering from haemorrhoids—whether internal or external—falling within Grades I to III will be considered for the study
Participants between the ages of 18 and 60 of any gender will be eligible
Only those who agree to undergo HOMOEOPATHY treatment and are ready to follow up as advised will be included
The study will involve individuals showing common symptoms such as rectal bleeding, pain during defecation, itching, or prolapse
Patients not currently under any form of alternative treatment or conventional medication for haemorrhoids will be selected
Patient of both sexes and all socio-economic class in 45-65 AGE group
Cases showing sign and symptom of haemorrhoid and other ano rectal disease or cases diagnosed as haemorrhoid & anal fissure are to be considered
 
 
ExclusionCriteria 
Details  1.Patients diagnosed with Grade IV haemorrhoids, or those advised to undergo surgical procedures, will not be taken into the study.
2.People suffering from other anorectal disorders like fistulas, or suspected malignancies will be excluded.
3.Individuals with significant health issues such as poorly managed diabetes, severe liver problems, or high blood pressure will not be considered.
4.Pregnancy or breasfeding women will be excluded to maintain both maternal and fetal safety during the study period.
5.Anyone unwilling to participate, or unable to commit to the study guidelines and follow-ups, will not be included.
6 Cases with diagnosed anal fistula, rectal cancer, or anorectal abscess.
7.Patients with systemic illnesses that may interfere with the treatment response (example, uncontrolled diabetes, HIV).
8. Individuals currently on long-term allopathic or corticosteroid treatment for the same condition.
9.Immunocompromised patients will be excluded from the study .
10.Patients with bleeding diathesis are excluded .(example-low platelets counts , blood clotting disorders )
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcomes are the reduction in pain intensity as measured by the Visual Analogue Scale and the improvement in the frequency and severity of rectal bleeding.  Duration of study is 18 months
These outcomes will be assessed at baseline Day 0 at the end of 4 weeks, and at the end of 8 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes include the assessment of changes in rectal swelling discharge from anus And bowel habits   General well being will be assessed qualitatively at each followup visit And final assessment will be done at the end of the study 
 
Target Sample Size   Total Sample Size="262"
Sample Size from India="262" 
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)   03/05/2026 
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="2"
Months="6"
Days="6" 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan

  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 [aparnabirari@gmail.com].

  6. For how long will this data be available start date provided 16-07-2025 and end date provided 16-02-2027?
    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   This study aims to evaluate and compare the therapeutic efficacy of Aesculus hippocastanum and Ratanhia peruviana mother tinctures in the homoeopathic management of haemorrhoids and ano-rectal disorders in patients aged 45–65 years.
 It focuses on assessing their role in relieving symptoms such as pain, bleeding, itching, and discomfort, and improving the quality of life. 
The research intends to provide clinical evidence for the effectiveness of these mother tinctures as safe and cost-effective treatment options.
 
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