| CTRI Number |
CTRI/2025/10/095600 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Ratanhia peruviana and Individualized Homoeopathic Medicines in the treatment of Haemorrhoids in adults. |
|
Scientific Title of Study
|
Effectiveness of Ratanhia peruviana versus Individualized Homoeopathic Medicines in the Management of Haemorrhoids in Adults: A Randomized 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 Madhu Verma |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No B17
Department of Practice of Medicine
Basement Floor
Bakson Homoeopathic Medical college and Hospital
Plot no 36B
Knowledge Park
Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
6306075456 |
| Fax |
|
| Email |
dr.vermamadhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Man Mohan Chamoli |
| Designation |
Guide and Assistant Professor |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No B16
Department of Practice of Medicine
Basement
Bakson Homoeopathic Medical college and Hospital
Plot no 36B
Knowledge Park
Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
767848833 |
| Fax |
|
| Email |
manu0001sm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Mathur |
| Designation |
HOD Department of Practice of Medicine |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No B16
Department of Practice of Medicine
Basement
Bakson Homoeopathic Medical college and Hospital
Plot no 36B
Knowledge Park
Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9868121727 |
| Fax |
|
| Email |
drakshaymathur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital Plot No 36B Knowlege Park Phase 1 Greater Noida Uttar Pradesh 201306 |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no G22
Principal Office
Ground Floor
Plot no 36 B Knowlege Park Phase 1
Greater Noida Uttar Pradesh 201306 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhu Verma |
Bakson Homoeopathic Medical College and Hospital Greater Noida Uttar Pradesh |
Out patient Department Room no 1 Ground floor Plot no 36B Knowledge Park Phase 1 Greater Noida Uttar Pradesh 201306
Gautam Buddha Nagar
UTTAR PRADESH |
6306075456
dr.vermamadhu@gmail.com |
| Dr Madhu Verma |
Dr D P Rastogi Central Research Institute of Homoeopathy |
OPD 110 Ground Floor A-1/1 Opposite HCL Sector 24
Noida
Uttar Pradesh
201307
Gautam Buddha Nagar
UTTAR PRADESH |
6306075456
dr.vermamadhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee. Bakson Homoeopathic medical college and Hospital |
Approved |
| Kendriya Homoeopathic Anusandhan Parishad |
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 |
| Comparator Agent |
Individualized Homoeopathic Medicines |
Participants in this group will receive Individualized Homoeopathic Medicines. Administration of pill oral route in centesimal Scale.
Pill size 30 no.
First dose after case taking. Repetition of dose according to follow up. |
| Intervention |
Ratanhia peruviana |
Participants in this group will receive Ratanhia peruviana.
Administration of pill oral route in centesimal Scale.
Pill size 30 no.
First dose after case taking.
Repetition of dose according to follow up. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
All Genders aged between 18-59years
Participants Clinically diagnosed with haemorrhoids by Digital Rectal Examination
Participants willing to participate and give informed consent
|
|
| ExclusionCriteria |
| Details |
Participants diagnosed with stage III stage IV internal haemorrhoids (prolapse haemorrhoids)
Participants diagnosed with fissure fistula anorectal abscess and polyp of rectum
Participants showing complication of haemorrhoids such as thrombosis gangrene and strangulation
Pregnant and lactating mothers
Participants with any psychiatric illness
Participants diagnosed any severe systemic illness other immunocompromised conditions
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare The Changes in VAS Scale in Ratanhia peruviana Group and Individualized Homoeopathic Medicines Group. |
Total 16 months
Enrollment period 6 months
Follow up duration 6 months
Data analysis 2 months
Report writing 2 months
Statistical data analyzed at baseline,at 12 weeks, 24 weeks
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
14/10/2025 |
| 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="4"
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
|
Evaluate and compare the effectiveness of Ratanhia peruviana and Individualized Homoeopathic medicines in managing Internal(Grade 1 and 2) and External Haemorrhoids in adults. 68 cases will be enrolled . 34 cases will be divided equally in both the groups . VAS Scale parameters (Pain,bleeding,itching,heaviness,discharges) is use in this study and repeated measures ANOVA will be use to assess the data at baseline 3 months and end of the 6 months. |