| CTRI Number |
CTRI/2024/12/078215 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A comparative study on the effectiveness of HOMOEOPATHIC MEDICINES belonging to VEGETABLE KINGDOM and MINERAL KINGDOM in the symptomatic management of PILES |
|
Scientific Title of Study
|
A comparative study on the effectiveness of HOMOEOPATHIC MEDICINES belonging to VEGETABLE KINGDOM and MINERAL KINGDOM in the symptomatic management of HAEMORRHOIDS |
| 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 SAJMA M M |
| Designation |
PG Scholar |
| Affiliation |
Government Homoeopathic Medical College,Thiruvananthapuram |
| Address |
Department of Homoeopathic Case Taking and Repertory
Government Homoeopathic Medical College
Iranimuttam
Thiruvananthapuram
Kerala
695009
India
Thiruvananthapuram
KERALA
695009
India |
| Phone |
8157905202 |
| Fax |
|
| Email |
sajmaayolikuni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MAYA B J |
| Designation |
Professor And HOD |
| Affiliation |
Government Homoeopathic Medical College,Thiruvananthapuram |
| Address |
Professor And HOD
Department of Homeopathic Case Taking And Repertory
Government Homeopathic Medical College
Iranimuttam
Thiruvananthapuram
KERALA
695009
INDIA
Thiruvananthapuram
KERALA
695009
India |
| Phone |
9544306474 |
| Fax |
|
| Email |
drMayaBJ@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MAYA B J |
| Designation |
GUIDE |
| Affiliation |
Government Homoeopathic Medical College,Thiruvananthapuram |
| Address |
PROFESSOR AND HOD
DEPARTMENT OF HOMOEOPATHIC REPERTORY AND CASE TAKING
GOVT HOMOEOPATHIC MEDICAL COLLEGE , IRANIMUTTAM , THIRUVANTHAPURAM
KERALA
695009
INDIA
KERALA
695009
India |
| Phone |
9544306474 |
| Fax |
|
| Email |
drMayaBJ@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVT Homoeopathic Medical College , Thiruvananthapuram
Iranimuttam
695 009-PIN
Kerala
|
|
|
Primary Sponsor
|
| Name |
Government Homoeopathic Medical College Thiruvananthapuram Kerala India |
| Address |
Post Graduate Scholar
Department of Homeopathic Case taking And Repertory
Government Homoeopathic Medical College , Iranimuttom , Thiruvananthapuram
Kerala
695009
India
|
| 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 Sajma M M |
Government Homoeopathic Medical College ,Thiruvananthapuram |
Special op 6,Department of Homoeopathic Case Taking and Repertory
Thiruvananthapuram
KERALA |
8157905202
sajmaayolikuni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K649||Unspecified hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HOMOEOPATHIC MEDICINES BELONGING TO VEGETABLE KINGDOM |
One Dose of Selected similimum belonging to Vegetable Kingdom will be given in the first two week interval ,Then one Dose in a four week interval . |
| Comparator Agent |
HOMOEOPATHIC MEDICINES BELONGING TO MINERAL KINGDOM |
One Dose of Selected Similimum Belonging to Mineral Kingdom will be given in the first two week interval, then one Dose once in a four week interval. L |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with first, Second and third degree haemorrhoids |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from other anorectal disorders like fissure in anus, Cancer of rectum ruptured perineal haematoma ,ruptured anorectal abscess, polyp, diverticular disease
2.Ulcerative colitis , Crohns disease ,
intussusceptions ,Ischaemic colon ,Ca anal canal
3.Severe bleeding ,Haemorrhoids with fourth degree |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical effectiveness of homoeopathic medicines belonging to vegetable kingdom and mineral kingdom |
Each case will be reviewed at 2 weeks interval and followed for 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A Assessment will be done by using CLORECTAL EVALUATION OF CLINICAL THERAPEUTIC SCALE. |
Each case will be reviewed at 2 weeks interval and followed for 6 month |
|
|
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 3 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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="1"
Months="0"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
Haemorrhoids is a chronic long lasting and relapsing disease ,Surgery is thought to be beneficial for severe Haemorrhoids , However managing the problems that arise after surgery, such as pain ,recurrence, convalescence , fecal urgency and anal stenosis, can be challenging. Homoeopathic medicines can manage such complications effectively. |