| CTRI Number |
CTRI/2024/07/071175 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to
assess the effect of probiotic on the risk of recurrence
and severity of symptoms in females with recurrent vulvovaginal candidiasis
|
|
Scientific Title of Study
|
A randomized, triple blinded, placebo controlled, parallel-group study to
assess the effect of a multi-strain probiotic on the risk of recurrence
and severity of symptoms in females with recurrent vulvovaginal candidiasis
(R-VVC) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ADM/230601/MSP/RVVC Version: 1.0 Date: 14th February, 2024 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr.Sajay Vaze |
| Designation |
Sr.Manager-Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
India
Mumbai
MAHARASHTRA
400053
India
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
India
Mumbai
MAHARASHTRA
400053
India
Mumbai
MAHARASHTRA
400053
India |
| Phone |
8655670964 |
| Fax |
|
| Email |
sanjay.v@vediclifesciences.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr.Sanjay Vaze |
| Designation |
Sr.Manager-Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
India
Mumbai
MAHARASHTRA
400053
India
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
India
Mumbai
MAHARASHTRA
400053
India
Mumbai
MAHARASHTRA
400053
India |
| Phone |
8655670964 |
| Fax |
|
| Email |
sanjay.v@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Raote |
| Designation |
Manager – Clinical Operations |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
India
Mumbai
MAHARASHTRA
400053
India
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
India
Mumbai
MAHARASHTRA
400053
India
Mumbai
MAHARASHTRA
400053
India |
| Phone |
02242172325 |
| Fax |
|
| Email |
sonal.raote@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Vedic Lifesciences Pvt. Ltd. 118-B, Morya House, off New Link Road, Andheri West Mumbai –
400053, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Malwina Naghibi |
| Address |
ADM Protexin Limited Lopen Head SomersetTA135JH,UK |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dipa Pitre |
Anand Multispecialty Hospital |
B-Tower
Sundervan complex,
Gorwa Refinery Rd,
near Gorwa, beside
IOCL Petrol pump,
Gorwa, Vadodara,
Gujarat 390016
Vadodara
GUJARAT
Vadodara
GUJARAT |
9825569008
dipapitre@gmail.com |
| Dr Ritika Khurana |
ENT& Vertigo Clinic |
102 shri sai chaitanya veerbhadra Nagar, Baner Pune
Pune
MAHARASHTRA |
9822699009
drritikakhurana@gmail.com |
| DrMeenakshi Samaria |
Janana Hospital |
6th Floor, Medical Research Cell, New Medicine Block, JLN Medical Hospital, Kala Bagh, Ajmer, Rajasthan – 305001
Ajmer
RAJASTHAN |
9413977333
dsf857@gmail.com |
| Dr Garima Singh |
Krishna Hospital |
Amra Chitaipur road Akhri Bypass, Varanasi 2210055, UP India
Varanasi
UTTAR PRADESH |
8528221044
drsinghgarima12@gmail.com |
| Dr Umesh Marathe |
Lifecare Hospital |
mumbai-Agra Highway,
Lekha nagar bus stop,
Nashik,422009
Nashik
MAHARASHTRA
Nashik
MAHARASHTRA |
9822073464
umeshmarathe15@gmail.com |
| Dr Kritika Pandey |
Matriva Womens Hospital |
02/03, Hari-Har Enclave CHS., Evershine city road, Evershine City, Vasai east, Vasai-Virar, Maharashtra, 401208
Thane
MAHARASHTRA |
9209326928
pandeykritika081@gmail.com |
| Dr Manvi Verma |
MGM Medical College |
MGM Medical College & Hospital ,Sector 1, Kamothe, Kalamboli, Mumbai, Maharashtra-410209.
Mumbai
MAHARASHTRA |
9469388553
drmanvi@drmanvi.com |
| Dr Archana Manoj Chandak |
Morya Multispecialty Hospital |
Ashwin Medical Foundation, Morya Multispecialty Hospital, Opposite PMP bus stop, power house chowk, Chinchwad Gaon, Pune- 411033, Maharashtra
Pune
MAHARASHTRA |
9890778855
amchandak2000@yahoo.com |
| Dr Poonam Goyal |
Panchsheel Hospital |
C-3/63A, 64A, opp. Gokulpuri police station, Block C, Yamuna Vihar, Shahdara, Delhi, 110053
Central
DELHI |
9811081811
Goyalpoonam29@gmail.com |
| Dr Deepti Sharma |
Parul Sevasharma Hospital |
Vadodara, P.O Limda, Tal, Waghodia Vadodra Gujrat 391760
Vadodara
GUJARAT |
9898317180
deeptisharma_403@yahoo.co.in |
| Dr Ruchika Garg |
S.N Medical College |
Moti katra mantola, agra -282003, U.P India
Agra
UTTAR PRADESH |
9720004485
Ruchikagargagra@gmail.com |
| Dr Megha Mane |
Sai Baba Hospital |
A 01, Siddhivinayak complex, Station Rd,IDBI Bank,near snehanjali, Nalasopara West, Mumbai, Maharashtra 401203
Mumbai
MAHARASHTRA |
7021553093
meghamane499@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Anand Institutional Ethics Committee |
Approved |
| Ethics Committee for Research on humam rights |
Approved |
| HARMONY ETHICAL RESEARCH COMMIITTEE |
Approved |
| HARMONY ETHICAL RESEARCH COMMIITTEE |
Approved |
| Institutional Ethics Committee Muktai Hospital |
Approved |
| Institutional Ethics Committee S.N Medical College |
Approved |
| Institutional Ethics Committee, Jawahar Lal Nehru Medical College |
Approved |
| Krishna Ethics Committee |
Approved |
| Morya Institutional Ethics Commiittee |
Approved |
| Parul institute of medical science & resaerch |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Waves Women Empowerment Trust |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
vulvovaginal candidiasis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
(a multi-strain probiotic – 1.0 x 109 CFU/capsule) |
Two capsules orally within 30-60 minutes post-breakfast daily |
| Comparator Agent |
Placebo [Microcrystalline cellulose (MCC) – 400 mg] |
Two capsules orally within 30-60 minutes post-breakfast daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Premenopausal women aged 18-50 years
2.Women with a culture-confirmed active episode caused by Candida spp. (albicans or non-albicans) reported within 24-48 hours of evidence of clinical symptoms. (No medications should have been initiated before the sample for culture is collected)
3.Documented history of recurrence of at least 3 VVC episodes in the last 12 months confirmed by vaginal culture per clinical diagnosis
4.Culture growth of Candida spp. causing VVC
5.Random Capillary Blood Glucose of less than 110mg per dl.
6.Willingness to consume the study products for the entire study duration.
7.Willing to complete all study procedures and comply with study requirements.
8.Willing to abstain from other supplements or medication.
9.Ready to give voluntary, written, informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Post-menopausal and peri-menopausal women.
2.Pregnant/breast-feeding women.
3.Use of oral or vaginal anti-fungal medication in the last 14 days.
4.Vaginal culture suggestive of bacterial vaginosis (Nugent’s score of 7-10), trichomonas vaginalis or Gardnerella vaginalis.
5.Participants found positive for Clotrimazole resistance by vaginal culture & sensitivity at screening.
6.Known history of allergy to Clotrimazole.
7.Women not willing to use any form of vaginal medication during the study.
8.Use of vaginal douching.
9.Unwillingness to use an appropriate method of contraception.
10.Diagnosed with compromised immune system, diabetes, or malignancies.
11.Use of Corticosteroids therapy in the last 30 days.
12.Use of oral or systemic antimicrobial therapy in the last 30 days.
13.Known allergy to the study products or azoles.
14.Individuals with a history of frequent infections requiring antibiotic treatments.
15.Participation in another clinical study(ies) in the last 3 months.
16.Women who, in the opinion of the Investigator, are considered to be poor clinical attendees or unlikely for any reason to be able to comply with the study.
17.Women with uncontrolled hypertension with systolic blood pressure more than equal to 140 mm Hg and or diastolic blood pressure more than equal to 90 mm Hg.
18.Heavy alcohol drinkers defined as follows: For men, consuming more than 4 drinks on any day or more than 14 drinks per week. For women, consuming more than 3 drinks on any day or more than 7 drinks per week.
19.Smokers
20.History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders that, in the judgment of the Investigator, would interfere with the participant ability provide informed consent, comply with the study protocol (which might confound the interpretation of the study results), or put the individual at undue risk.
21.Presence of unstable, acutely symptomatic, or life-limiting illness.
22.Use of any supplements (includes probiotics, post-biotics, herbal supplements, synbiotics, enzyme supplements, vitamins with probiotics) in the last 30 days
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of the Investigational Product (IP) on incidence of culture-confirmed VVC recurrence (VVC recurrence defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days) as compared to placebo.
|
Day 180 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To compare Efficacy of the Investigational Product (IP) on incidence of culture-confirmed VVC recurrence (VVC recurrence defined as a fungal culture positive vaginal swab with at least 2 moderate VVC related symptoms or at least 1 severe VVC related symptom and with VVC free period prior to this incident of at least 7 days) as compared to placebo |
Day 90 |
| To compare Efficacy of the Investigational Product (IP) on Time taken to first recurrence of VVC episode from baseline between IP and placebo groups |
day 0 to first VVC recurrence |
| To compare Efficacy of the Investigational Product (IP) on Number of days with VVC episode between IP and placebo groups |
during the vulvovaginal candidiasis episodes, till day 180 |
| To compare Efficacy of the Investigational Product (IP) on incidence of Severity of VVC episodes as assessed by symptoms (itching/soreness, edema, dysuria, vaginal discharge, dyspareunia, erythema, fissures/excoriations) severity on a 4-point Likert Scale as compared to baseline and placebo |
during episodes |
| To compare Efficacy of the Investigational Product (IP) on Proportion of C. albicans positive VVC episodes vs other pathogens |
during episodes |
| Number of administrations of To compare Efficacy of the Investigational Product (IP) on vaginal pessaries during acute episodes as compared to baseline and placebo |
during episodes |
| To compare Efficacy of the Investigational Product (IP) on Changes in vaginal health as assessed by vaginal pH as compared to baseline and placebo |
day 0, day 90, day 180 |
| To compare Efficacy of the Investigational Product (IP) on Changes in vaginal microbiology as assessed by vaginal Candida albicans culture as compared to baseline and placebo |
during episodes |
| To compare Efficacy of the Investigational Product (IP) on Quality of life as assessed using SF-36 as compared to baseline and placebo |
day 0, day 90, day 180 |
| Exploratory endpoint:Influence of IP on vaginal microbiome in R-VVC as assessed by Shotgun analysis on vaginal swab sample |
day 0, day 90 & day 180) |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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 4 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The present study is a randomized, placebo-controlled, triple-blind clinical study. 158 individuals will be screened, and considering a screening failure rate of 20 percent, approximately 126 participants will be randomized in a ratio of 1 is to 1 ratio to receive either a multi-strain probiotic or placebo and will be assigned a unique randomization code. Each group will have at least 54 completed participants after accounting for a dropout/withdrawal rate of 15 percent The intervention duration for all the study participants is 180 days |