| CTRI Number |
CTRI/2025/09/094999 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Utility of Boger Boenninghausen’s Characteristic and Repertory in cases of Hemorrhoids |
|
Scientific Title of Study
|
Utility of Boger Boenninghausen’s Characteristic and Repertory in cases of Hemorrhoids using Goligher’s classification and Hemorrhoidal disease
symptom score. |
| 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 Parth Bhatt |
| Designation |
PG Scholar |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute |
| Address |
Room no.5, Department of Homoeopathic medicine and surgery, Anand Homoeopathic Medical College and Research Institute and AnandHomoeopathic Hospital Near Sardar baug, Bhalej Road Anand-388001
Anand
GUJARAT
388001
India |
| Phone |
9426451751 |
| Fax |
|
| Email |
parthbhatt1717@gmail.coM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Shah |
| Designation |
MD(Hom.), MBA, Master in Political Science |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute |
| Address |
Room no.5, Department of Homoeopathic medicine and surgery,Anand Homoeopathic Medical College and Research Institute and Anand,Homoeopathic Hospital Near Sardar baug, Bhalej Road Anand-388001
Anand
GUJARAT
388001
India |
| Phone |
9327226888 |
| Fax |
|
| Email |
nikirhomoeotimes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Shah |
| Designation |
MD(Hom.), MBA, Master in Political Science |
| Affiliation |
Anand Homoeopathic Medical College and Research Institute |
| Address |
Room no.5, Department of Homoeopathic medicine and surgery,Anand Homoeopathic Medical College and Research Institute and Anand,Homoeopathic Hospital Near Sardar baug, Bhalej Road Anand-388001
Anand
GUJARAT
388001
India |
| Phone |
9327226888 |
| Fax |
|
| Email |
nikirhomoeotimes@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anand Homoeopathic Medical College and Research Institute and Anand Homoeopathic Hospital Anand, Gujarat-388001 |
|
|
Primary Sponsor
|
| Name |
Dr Parth Bhatt |
| Address |
45-Police line HimmatPura Road Nr. Jaymataji Chowk Bhachau-370140 |
| Type of Sponsor |
Other [Self] |
|
|
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 Parth Bhatt |
Anand Homoeopathic Hospital |
Room no.5, Department of Homoepathic medicine and surgery,Opp. Sardar baug, Nr.New Bus stand, Anand,Gujarat, Anand, Gujarat388001, India
Anand
GUJARAT
Anand
GUJARAT |
9426451751
parthbhatt1717@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Anand homoeopathic medical college and research institute Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K64||Hemorrhoids and perianal venous thrombosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine |
The medicine will be prescribed after doing repertorization with the help of BBCR and final choice will be made with the help of Materia Medica. The potencies 6C,30C,200C,1Metc. will be selected depending upon the susceptibility of the patient. The remedy will be repeated as per the requirement of the case. Medicine will be given orally. The duration of study is of 18 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients above 18 years of age groups and both genders are eligible for the study.
2) Patients with diagnosed cases of grade 1, grade 2, grade 3 of hemorrhoids whether it is acute or chronic are eligible for study
3) Patients who are willing and are able to comply with the study protocol, including taking homeopathic treatment, attending follow-up
|
|
| ExclusionCriteria |
| Details |
1) 4th degree Hemorrhoids will be excluded
2) Hemorrhoids with complication like infection, thrombosis, gangrene, pylephlebitis, fibrosis etc. will be excluded
3) Patients who are unable or unwilling to comply with the study protocol and attending follow-up will be excluded
4) Patients below 18 years of age will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Based on Hemorrhoidal disease
symptom score |
At the baseline and at the end of each Follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/10/2025 |
| 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
|
The Hemorrhoids are more pathological and main stay of treatment is surgical but in operative Hemorrhoidectomy is usually associated with many postoperative complications like pain, bleeding, anal strictures, retention of urine, fissure, abscess etc. which can result in protracted period of convalescence. Homoeopathic medicines are extremely effective in treatment of hemorrhoids This study will emphasis on incidence, evaluation, pathophysiology, clinical feature and management of Hemorrhoids with discussion of Homoeopathic medicines indicated in this clinical condition using BBCR. Homoeopathic literature acknowledges many medicines for the Hemorrhoidal condition of which a simillimum can help a patient for keeping the disease far away for long period and offer a gentle and safe relief. |