| CTRI Number |
CTRI/2022/03/041393 [Registered on: 25/03/2022] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study of Colloidal Nano Silver Gel in the treatment of vaginal infections |
|
Scientific Title of Study
|
A Multicentre, Randomized, Double blind, Placebo controlled Pilot Study to evaluate the Efficacy and Safety of Colloidal Nano Silver Gel (SilverSol®) in the treatment of Bacterial Vaginosis, Vulvovaginal
Candidiasis and Trichomoniasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-VIR-001 Version 1.0 Dated 09 Nov 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Padma Srivastava |
| Designation |
Principal Investigator |
| Affiliation |
Prarthna Clinic |
| Address |
Prarthna Clinic
Picasso Kedari Arcade,Flat no 103, Salunke Vihar, Wanowrie Pune- 411040, Maharashtra
Pune
MAHARASHTRA
411040
India |
| Phone |
9810965671 |
| Fax |
|
| Email |
drpadma_srivastava@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt.Ltd |
| Address |
Office No. 02, 03 & 04, Second Floor, Highland Corporate Center,Kapurbawdi Junction, Thane (W),Maharashtra
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashank S Jadhav |
| Designation |
Medical Director |
| Affiliation |
Viridis BioPharma Pvt Ltd |
| Address |
Universal Majestic, 1503, PL Lokhande Marg, Chembur, Mumbai, Maharashtra 400071, India
Mumbai
MAHARASHTRA
400071
India |
| Phone |
02262669600 |
| Fax |
|
| Email |
shashank@synergialifesciences.com |
|
|
Source of Monetary or Material Support
|
| Viridis BioPharma Pvt. Ltd
1503, Universal Majestic, P. L. Lokhande Marg,
Ghatkopar - Mankhurd Link Road,
Govandi,
Mumbai - 400 043,
INDIA. |
|
|
Primary Sponsor
|
| Name |
Viridis BioPharma Pvt Ltd |
| Address |
1503, Universal Majestic, P. L. Lokhande Marg, Ghatkopar - Mankhurd Link Road, Govandi, Mumbai - 400 043, INDIA. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alaka Godbole |
Akshay Surgrical and Maternity Home |
1st Floor, OPD room,Savio Apartments,Opp Kolbadnaka ,Old Agra Road, Thane West, 400601.
Thane
MAHARASHTRA |
9833967970
godbole369@gmail.com |
| Dr Padma Srivastava |
Prarthna Clinic |
Picasso Kedari Arcade,Flat no 103, Salunke Vihar, Wanowrie Pune- 411040, Maharashtra
Pune
MAHARASHTRA |
9810965671
drpadma_srivastava@hotmail.com |
| Dr Neena Nichlani |
Titan Hospital |
Ground floor, Soham Plaza,Near Manpada Circle,Godbhunder Road,Manpada-Thane West-400607.
Thane
MAHARASHTRA |
9820535378
neena0611@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ethics Committee Inamdar Multispeciality Hospital |
Submittted/Under Review |
| V Care Independent Ethics Committee, |
Approved |
| Vcare Independent Ethics committee _Dr.Alaka Godbole |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Colloidal Nano Silver Gel (SilverSol®) |
The dose is one 4 gm application inserted into the vagina once daily at bedtime for internal use and 2 gm gel for local application to vagina for external use twice daily for a period of 14 days. |
| Comparator Agent |
Placebo (Vehicle) gel |
The dose is one 4 gm application inserted into the vagina once daily at bedtime for internal use and 2 gm gel for local application to vagina for external use twice daily for a period of 14 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Postmenarchal female subjects between 18 to 65 years of age (Both Inclusive).
2. Subjects must have a confirmed clinical diagnosis of vaginal infection with any one, two or all of the following inclusion criteria-
a) Diagnosis of bacterial vaginosis based on the presence of all four Amsel criteria.Homogeneous vaginal discharge (off white, milky or gray, thin), positive KOH whiff test,vaginal secretions,pH of > 4.5, Clue cells ≥ 20 percent of vaginal squamous epithelial cells on saline wet mount.
And/or
b) Diagnosis of Vulvovaginal Candidiasis(VVC) demonstrating presence of yeast forms (hyphae or pseudohyphae) or budding yeasts on the KOH or saline preparation from the inflamed vaginal mucosa or secretions with two or more signs and symptoms of VVC and Vaginal pH less than or equal to 4.5.(Signs: edema, redness, or excoriation. Symptoms: itching, burning, and/or irritation)
And/or
c) Diagnosis of Trichomoniasis at the screening visit as determined by Positive wet mount assessment for Trichomonas vaginalis with any one of the symptoms (i.e. itching, discharge and odor).
3. Subjects who agree to refrain from the use of intra-vaginal products throughout the study (e.g., douches, feminine deodorant sprays,Spermicides, tampons, and diaphragms).
4. Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures. |
|
| ExclusionCriteria |
| Details |
1. Subjects with other infectious causes of vulvovaginitis e.g Chlamydia trachomatis, Neisseria gonorrhoeae, Herpes simplex.
2. Presence of any condition or illness, including vulvar and vaginal conditions, that in the opinion of the investigator would preclude accurate evaluation of the subject’s condition and/or confound the interpretation of the subject’s treatment response.
3. Subject with history of cervical intra-epithelial neoplasia (CIN) or cervical carcinoma.
4. Subjects using systemic (oral, intravenous [IV], or intramuscular [IM]), intravaginal/ vulvovaginal antifungal, antimicrobial, or corticosteroid therapy within 14 days of participation in the study.
5. Subjects who are currently on any anticoagulation therapy or immunosuppressive therapy.
6. Pregnant, lactating, or planning to become pregnant during the study period.
7. Use of any investigational drug within 30 days of enrollment or plans to use other investigational products while enrolled in the study
8. History of hypersensitivity to Colloidal Silver or any other ingredient of the formulations. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects achieving clinical cure at end of study Visit. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects achieving microbiological cure at end of study Visit. |
15 days |
| The assessment of safety of Investigational Product will be based on the frequency of Adverse Events. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/04/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is A Phase II, Multicentre, Randomized, Double blind, Placebo controlled Clinical Study to evaluate the Efficacy and Safety of Colloidal Nano Silver Gel (SilverSol®) in the treatment of Bacterial Vaginosis, Vulvovaginal Candidiasis and Trichomoniasis
The objective is to evaluate the efficacy an safety of Colloidal Nano Silver Gel (SilverSol®) in the treatment of Bacterial Vaginosis, Vulvovaginal Candidiasis and Trichomoniasis.
Primary Endpoint: -Proportion of subjects achieving clinical cure at end of study Visit.
Secondary Endpoint Proportion of subjects achieving microbiological cure at end of study Visit. |