| CTRI Number |
CTRI/2024/07/070567 [Registered on: 13/07/2024] Trial Registered Prospectively |
| Last Modified On: |
13/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Effective homoeopathic treatment for piles with evidence |
|
Scientific Title of Study
|
Evidence based interventional study of Haemorrhoids with the Homoeopathic therapeutics of Haemorrhoids by Dr W M J Guernsey |
| 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 Priya Vitthal Patil |
| Designation |
Phd Scholar |
| Affiliation |
Sonajirao Khirsagar Homoeopathic Medical College & Hospital Beed |
| Address |
Opd no 1 Department of Surgery floor no1 SKMHC Vidya Nagar WEST College road
Beed MS 431122
Vidya Nagar WEST College road
Beed MS 431122
Bid
MAHARASHTRA
431122
India |
| Phone |
9822289103 |
| Fax |
|
| Email |
vishwaja2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajiv Ghuge |
| Designation |
Professor |
| Affiliation |
Sonajirao Khirsagar Homoeopathic Medical College & Hospital Beed |
| Address |
OPD No 1 Department of Surgery
Floor No 1 SKHMC Vidya Nagar WEST College road
Beed
Vidya Nagar WEST College road
Beed MS 431122
Bid
MAHARASHTRA
431122
India |
| Phone |
9822289103 |
| Fax |
|
| Email |
drrbghuge@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Vitthal Patil |
| Designation |
Ph D Scholar |
| Affiliation |
Sonajirao Khirsagar Homoeopathic Medical College & Hospital Beed |
| Address |
OPD NO 1 Department of Surgery
floor no 1 Vidya Nagar WEST College road
Beed MS
Vidya Nagar WEST College road
Beed Maharashtra 431122
Bid
MAHARASHTRA
431122
India |
| Phone |
9822289103 |
| Fax |
|
| Email |
vishwaja2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sonajirao Kshirsagar homoeopathic Medical College vidhya nagar west college road
beed 431122 Maharasthra |
|
|
Primary Sponsor
|
| Name |
Dr Priya Vitthal Patil |
| Address |
Sonajirao Khirsagar Homoeopathic Medical college Vidhya Nagar west college road Beed Maharashtra pin 431122 |
| 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 Priya Patil |
Sonajirao Kshirsagar Homoeopathic Medical College, Beed |
Department of Surgery floor no 2 OPD 1 Vidya Nagar College Road Beed
Bid
MAHARASHTRA |
9822289103
vishwaja2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sonajirao Kshirsagar Homoeopathic Medical College, Beed |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K640||First degree hemorrhoids, (2) ICD-10 Condition: K643||Fourth degree hemorrhoids, (3) ICD-10 Condition: K641||Second degree hemorrhoids, (4) ICD-10 Condition: K642||Third degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sulphur Nux Vomica |
Dose 200 potency
route of administration oral
Follow up will be taken every one month
Duration 6 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Internal idiopathic/primary haemorrhoids presenting with any of the symptoms, namely, bleeding,
pain heaviness, pruritus, and mucus discharge with or without annites.
controlled diabetes and controlled hypertension and thyroid disorders.
Patients using topical agents for haemorrhoids will be included after a washout period of 1-week,
subject to persistence of symptoms and signs of haemorrhoid |
|
| ExclusionCriteria |
| Details |
Exclusion criteria will be Grade IV piles, anal fissure and fistula, acute thrombosed piles, hereditary piles,
infective piles, inflammatory bowel disease, enlarged prostate, chronic alcoholism, recreational drug abuse,
coagulation disorders, previous history of surgery for haemorrhoids, hypertrophic anal papillae, rectal
malignancies, history of leukemic disorders, patients with obstruction of portal circulation, pregnancy
leading to obstruction of the portal circulation, lactating mothers, patients with psychiatric diseases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction OF Degree /grade of haemorrhoids with constant relief in pain |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain tenderness swelling should be reduced |
1wk to 3 wk |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 4 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="2"
Months="0"
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
|
Haemorrhiods are recognized as one of the most common medical condition defined as cluster of vascular tissue ,smooth muscle & connective tissue arranged in three column along the anal canal . This interventional study of haemorrhoids with the Homoeopathic therapeutics of haemorrhoids by Dr W M J Guernsey patients with symptosmof haemorrhoids & detail case taken after proper examination & medicine is prescribe after indivisualisation of a case .Assessment by using short form 12 i.e. SF 12. |