| CTRI Number |
CTRI/2025/09/094609 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of observations of the effects after giving homoeopathic medicines in cases of vaginal infections in females |
|
Scientific Title of Study
|
Study on the role of Kent’s 12 observations in the management of Bacterial Vaginosis in females of reproductive age group (15-50 years). |
| 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 Sneha Kamlesh Dharmani |
| Designation |
P G student |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College and Research Centre |
| Address |
Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri PUNE 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9403306483 |
| Fax |
|
| Email |
snehadharmani0101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sneha Kamlesh Dharmani |
| Designation |
P G student |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College and Research Centre |
| Address |
Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri PUNE 411018
MAHARASHTRA
411018
India |
| Phone |
9403306483 |
| Fax |
|
| Email |
snehadharmani0101@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Patil |
| Designation |
Professor |
| Affiliation |
Dr D Y Patil Homoeopathic Medical College and Research Centre |
| Address |
Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri PUNE 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8888881525 |
| Fax |
|
| Email |
shweta.patil@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| OPD and IPD Department of Organon of Medicine and Homoeopathic Philosophy ground floor Dr D Y Patil Homoeopathic Medical College and Research Centre Pimpri Pune India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Sneha Kamlesh Dharmani |
Dr D Y Patil Homoeopathic Medical College and Research Centre Sant Tukaram Nagar Pimpri Pune 411018 |
OPD and IPD Complex first floor Department of Organon of Medicine and Homoeopathic Philosophy Dr D Y Patil Homoeopathic Medical College and and Research Centre Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA |
9403306483
snehadharmani0101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr D Y Patil Homoeopathic Medical College and Research Centre Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N899||Noninflammatory disorder of vagina, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine |
Dose 30 Potency
Frequency Thrice daily
Route of administration Oral
Duration of Intervention 3 months |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Clinically diagnosed cases of females
Patients presenting with symptoms of abnormal vaginal discharge
Nugent score greater than 4 |
|
| ExclusionCriteria |
| Details |
Women taking antibiotic therapy for bacterial vaginosis
Nugent score less than 4
Female above age of 50 years and below the age of 15 years
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce Nugent score with the help of individualised Homoeopathic treatment using Kents 12 observations in cases of bacterial vaginosis |
To reduce Nugent score with the help of individualised Homoeopathic treatment using Kents 12 observations in cases of bacterial vaginosis in 3 to 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve the symptoms of bacterial vaginosis with the help of homoeopathic medicine |
To improve the symptoms of bacterial vaginosis with the help of homoeopathic medicine within 1 month to 2 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/10/2025 |
| 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
|
This study focuses on management of cases of Bacterial Vaginosis with the help of Kents 12 observations this study is a single arm interventional study which focuses on females of age 15 to 50 years presenting with symptoms of bacterial vaginosis with gram stain and Nugent score greater than 4 The Kents 12 observations will be useful in reduction or resolution of symptoms of bacterial vaginosis and prevent recurrence of bacterial vaginosis and reduce Nugents score to less than 4 |