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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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