| CTRI Number |
CTRI/2024/05/066638 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of before and after outcome of bacterial vaginosis by homoeopathic medicine in reproductive age group women comparing its effect through in- vitro |
|
Scientific Title of Study
|
Assessment of pre and post therapeutic outcome of reproductive age group women suffering from bacterial vaginosis by individualized homoeopathic medicine comparing its effect through in- vitro analysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka chourasia |
| Designation |
Post graduate trainee |
| Affiliation |
National Institute of Homoeopathy kolkata |
| Address |
Department of organon of medicine
OPD no 14 organon of medicine 31 Obstetrics and Gynaecology
GE BLOCK sector 3
salt lake
kolkata
west bengal
Kolkata WEST BENGAL 700106 India |
| Phone |
8617233576 |
| Fax |
|
| Email |
chourasiapriyanka900@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ompriya Mishra |
| Designation |
Professor and HOD of Department of Obstetrics and Gynaecology |
| Affiliation |
National Institute of Homoeopathy kolkata |
| Address |
Department of Obstetrics and Gynaecology
GE BLOCK sector 3
salt lake
kolkata
Kolkata WEST BENGAL 700106 India |
| Phone |
8240359414 |
| Fax |
|
| Email |
drompriyanih@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ompriya Mishra |
| Designation |
Professor and HOD of Department of Obstetrics and Gynaecology |
| Affiliation |
National Institute of Homoeopathy kolkata |
| Address |
Department of Obstetrics and Gynaecology
GE BLOCK sector 3
salt lake
kolkata
Kolkata WEST BENGAL 700106 India |
| Phone |
8240359414 |
| Fax |
|
| Email |
drompriyanih@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy
GE block sector 3 saltlake kolkata - 700106 west bengal |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
GE block Sector 3 Salt Lake Kolkata-700106
west bengal |
| Type of Sponsor |
Government 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 |
| Dr Priyanka chourasia |
National Institute of Homoeopathy |
GE block sector 3 saltlake
Department of Organon of medicine
opd - 14 (opd of obstetrics and gynaecology 31 ) Kolkata WEST BENGAL |
8617233576
chourasiapriyanka900@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional ethical committee of the national institute of homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N760||Acute vaginitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic medicine |
A) individualised Homoeopathic medicine selected after the consultation of homoeopathic materia medica.
B) homoeopathic medicines should be given in centesimal or fifty Millesimal
C)potency will be according to case and dose will be minimum dose that is single dose
route of administration will be through tounge
remedy will be given for 1 month duration.
D)Data will be entered at the point of entry that is baseline and after 3 months of study will be recorded with Hays classification with Nugent scoring and VSQ21 Score |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Patients suffering from symptoms of vaginal white discharge.
Patient who’s satisfying the Amsel’s criteria.
Patient age group 15-49 years of female, of any religion, of any socio-economic background.
Patents who know and understand either Hindi or English or Bengali.
Patients who are willing to give assent and/or consent.
Patients who are willing to give consent for clinical examination and sample collection. |
|
| ExclusionCriteria |
| Details |
Patients suffering from other infectious disease like trichomoniasis, candidiasis.
Patient who’s taking OCPs, who’s Pregnant and lactating.
Patient who are already taking homoeopathic treatment for any other chronic disease.
Patient suffering from any life threatening/ Psychiatric/ systemic illness or Immunocompromised state or other significant disease conditions.
Substance abuse and/or dependence.
History of antibacterial therapy within two weeks prior to their attendance.
Women with genital malignancy excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of change in the symptoms will be recorded on the basis of score either increase or decrease obtained by VSQ21 and Hay’s classification system with Nugent scoring. |
baseline and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
14/05/2024 |
| 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="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
|
Bacterial vaginosis is a commonly occurring vaginal infection that leads to an abnormal vaginal discharge and unpleasant odour. conventional, widely-utilized approach for diagnosing bacterial vaginosis relies on Amsel’s Criteria (~90% sensitivity and specificity): 1. White, milky, no viscous discharge adherent to the vaginal wall 2. pH of the discharge is more than 4.5 3. The presence of clue cells (vaginal epithelial cells with adherent Gardnerella on high-power microscopic examination after adding a drop of normal saline to a vaginal fluid smear (wet mount), and 4.A positive “whiff test†upon application of a few drops of 10% potassium hydroxide (alkaline solution) to a sample of vaginal fluid. after patient’s consent, clinically per speculum examination will be done without any lubricant to see the colour, odour of the discharge, to evaluate the Amsel’s criteria. Discharge collected twice with sterile vaginal swab collection kit one for the whiff test and other for the culture in agar plate. Instantly pH will be determined with pH strip. Analysis and evaluation of the symptoms will be done as per guidelines of homoeopathic philosophy and further constructing the totality in accordance to it. Repertorisation will be done if needed then Final selection of medicine will be done after consulting the homoeopathic Materia medica Potency, dose and repetition of medicine will be decided according to homoeopathic principles General management such as personal hygiene and proper lifestyle modification will be advised to each and every patient. Swab transferred to Pathology lab of National Institute of Homoeopathy for the culture in nutrient agar plate and which usually takes 36-48 hours. After 48 hours, Gram staining will be done to know the predominate microbes. Biochemical test will be done of that predominate microbes in the Pathology lab, to know the species. Monthly follow up will be done monthly at least for 3 months. Data from Hay’s classification of Nugent score and VSQ21 score will be collected at baseline and after 3 months of study. After collection of desired samples and after knowing the predominate organism antimicrobial study will be done with the given medicine which is found effective. |