| CTRI Number |
CTRI/2025/08/093375 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Homoeopathic Medicines in the treatment of Bacterial Vaginosis |
|
Scientific Title of Study
|
Evaluating the effectiveness of Oral Individualized Homoeopathic
Medicines Versus Hydrastis Canadensis Tincture as a local application in the treatment of
Bacterial Vaginosis: An open label Randomized Controlled Clinical Trial |
| 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 Divya Bharti |
| Designation |
PG Scholar |
| Affiliation |
Dr B R Sur Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Practice of Medicine,Dr B R Sur Homoeopathic Medical College, Hospital and Research Centre, Nanak Pura, Moti Bagh, New Delhi
South West
DELHI
110021
India
South West
DELHI
110021
India |
| Phone |
8506007577 |
| Fax |
|
| Email |
divyabharti768@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Narang |
| Designation |
Professor, Department of Practice of Medicine |
| Affiliation |
Dr B R Sur Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Practice of Medicine,Ground floor, Dr B R Sur Homoeopathic Medical College Hospital and Research Centre Nanakpura Motibagh
South West
DELHI
110021
India |
| Phone |
9871347553 |
| Fax |
|
| Email |
Shmc.thyroidclinic@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Bharti |
| Designation |
PG Scholar |
| Affiliation |
Dr B R Sur Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Practice of Medicine,Dr B R Sur Homoeopathic Medical College Hospital and Research Centre, Nanakpura, Moti Bagh
South West
DELHI
110021
India |
| Phone |
8506007577 |
| Fax |
|
| Email |
divyabharti768@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Sur Homoeopathic Medical College Hospital and Research Centre Nanakpura, Motibagh, New Delhi-110021 |
|
|
Primary Sponsor
|
| Name |
Dr Divya Bharti |
| Address |
Dr B R Sur Homoeopathic Medical College Hospital and Research Centre,Nanakpura,Moti Bagh New Delhi-110021
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 Divya Bharti |
Dr B R Sur Homoeopathic Medical College Hospital and Research Centre |
Department of Practice of Medicine, Dr B R Sur Homoeopathic Medical College Hospital and Research Centre,Nanakpura,Moti Bagh
South West
DELHI |
8506007577
divyabharti768@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: N898||Other specified noninflammatory disorders of vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hydrastis Canadensis Tincture with placebo |
Hydrastis Canadensis q/10gtt in half cup of water
as a local application will be given twice daily for 2 weeks along with oral placebo.
Route of administration: local(as a wash) and oral(in the globules form)
Duration: 6 months |
| Intervention |
Individualized Homoeopathic Medicines |
Individualized Homoeopathic Medicines will be
administered in centesimal potencies, selected
according to homoeopathic principles. The dose
and repetition will be done as per the requirement
of each case. The route of administration will be
Oral, in globules form. Duration: 6 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. women of age group 18-45 years.
2. Women presenting with sign and symptoms of Bacterial Vaginosis as per Amsel’s and Nugent
Scoring |
|
| ExclusionCriteria |
| Details |
1. Pregnancy or Lactation: Women who are pregnant or breastfeeding.
2. Concurrent Vaginal Infections: Presence of other sexually transmitted infections.
3. Severe Comorbidities: Significant medical conditions (e.g., diabetes, immunosuppression)
that could affect treatment outcomes. Recent Surgical Procedures: Any recent
gynecological surgeries or interventions.
4. Hormonal Treatments: Use of hormonal therapies (e.g., contraceptives, hormone
replacement therapy) that may influence vaginal flora.
5. Uncontrolled Medical Conditions: Any uncontrolled systemic conditions that could impact
health or treatment efficacy.
6. Allergies to Study Remedies: Known allergies or sensitivities to any homoeopathic
remedies being tested.
7. Non-compliance Risk: Individuals who may not adhere to the study protocol or followup
requirements. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. This trial is expected to indicate that individualized homoeopathic medicines will have greater
therapeutic benefits as compared to Hydrastis Canadensis in treatment of Bacterial Vaginosis |
11 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.This study aims to identify a group of most effective homeopathic medicine in the management of Bacterial Vaginosis
2.The study anticipates that homeopathic medicine will show positive effects by improving Amsel’s criteria and Nugent’s score in the treatment of Bacterial Vaginosis
3.This study intends to explore the effectiveness of individualized homeopathic remedies in
providing long-term relief and preventing the recurrence of Bacterial Vaginosis |
11 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="0"
Months="11"
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 compares the effectiveness of individualized homoeopathic medicines and local hydrastis canadensis tincture with placebo in treating patients with Bacterial Vaginosis, aged 18-45 years. Patients will be randomly assigned to receive either individualized homoeopathic medicines or local hydrastis canadensis tincture with placebo.The study will measure the outcomes using Amsel’s criteria, Nugent scoring and vaginal discharge assessment form. The results will provide valuable insights into the effectiveness of homoeopathic approaches in treating Bacterial Vaginosis. |