| CTRI Number |
CTRI/2022/06/042994 [Registered on: 03/06/2022] Trial Registered Prospectively |
| Last Modified On: |
02/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Individualized Homoeopathic medicines in treatment of White Discharge in Females |
|
Scientific Title of Study
|
Usefulness of Individualized Homoeopathic Medicines in Treatment of Leucorrhoea- A Prospective Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mouli Biswas |
| Designation |
PG SCHOLAR |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no 311
Floor 3rd floor
Department of Paediatrics
Bakson Homoeopathic Medical College and Hospital
36B Knowledge Park 1 Phase 1 Greater Noida Distt Gautam Buddha Nagar Uttar Pradesh
nil
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9607223527 |
| Fax |
|
| Email |
moulibiswas95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Asistant Professor & Guide |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room number LG 002
Floor Lower Ground
Bakson Homoeopathic Medical College and Hospital 36B Knowledge Park 1 Phase 1 Greater Noida Distt Gautam Buddha Nagar
nil
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9818216191 |
| Fax |
|
| Email |
dr.ajaybhati28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Garg |
| Designation |
Head Of Department |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room number 311
Floor 3rd floor
Department of Paediatrics
Bakson Homoeopathic Medical College and Hospital
36B Knowledge Park 1 Phase 1 Greater Noida Distt Gautam Buddha Nagar
nil
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9411437669 |
| Fax |
|
| Email |
drpuneetgarg18@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no G22
Ground floor
36B Knowledge Park 1 Phase 1 Greater Noida Distt Gautam Buddha Nagar |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Mouli Biswas |
Bakson Homoeopathic Medical College and Hospital |
Out Patient Department (OPD)
Room No 1
Ground Floor
36B Knowledge Park 1 Phase 1 Greater Noida Distt Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
9607223527
moulibiswas95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Bakson Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N898||Other specified noninflammatory disorders of vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines |
Homoeopathic Medicine
Oral route of administration
Globules form
30 pill size
Centesimal scale
Follow up in every 2 weeks 4 weeks 8 weeks 12 weeks till 6 months
Repetition of dose according to follow up for 6 months |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Female |
| Details |
1 Females of under 18 years of age
2 Females having vaginal discharge with associate symptoms like low back ache pain in calve constipation weakness and tiredness pruritus vulva
3 Females having vaginal discharge of any kind as presenting complaint irrespective of any associated symptoms
|
|
| ExclusionCriteria |
| Details |
1 Patients undergoing any other medical intervention for leucorrhoea
2 Females taking any hormonal pills
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Vaginal Discharge Assessment Form- Scale |
12 month study
5 months enrollment
6 months follow up
1 month analysis
Follow up every 2 weeks.
Vaginal Discharge Assessment Form will be assessed at baseline, 4 weeks, 8 weeks, 12 weeks till 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
07/06/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to assess the role of Individualized Homoeopathic medicine in LeucorrhoeaProspective Observational Study Vaginal Discharge Assessment form will be used Single arm study |