| CTRI Number |
CTRI/2025/10/095909 [Registered on: 10/10/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to find the Effect of Tioconazole Vaginal Film |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL EVALUATION OF EFFICACY AND SAFETY OF TIOCONAZOLE VAGINAL FILM VS CANESTEN V6 VAGINAL TABLET IN THE MANAGEMENT OF SYMPTOMATIC VULVOVAGINAL CANDIDIASIS IN NON-PREGNANT WOMEN - OPEN LABEL, RANDOMIZED, PARALLEL, PROSPECTIVE, MULTICENTRIC STUDY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HHCL/01-01/24; Version No.:1.0; Version Date: 18/01/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr U Shobha Jagdish Chandra |
| Designation |
Head of Department (HOD) |
| Affiliation |
Hetero Healthcare Limited |
| Address |
Dept. of Clinical Pharmacology and Therapeutics, Hetero Healthcare Ltd, Sy. no 83/1, Plot Nos. 16/A/1 and 16/A/2
19th and 20th Floor, Hetero Tower, Commerzone, Madhapur.
Hyderabad
TELANGANA
500081
India |
| Phone |
9704416425 |
| Fax |
|
| Email |
shobhaudutha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U Shobha Jagdish Chandra |
| Designation |
Head of Department (HOD) |
| Affiliation |
Hetero Healthcare Limited |
| Address |
Dept. of Clinical Pharmacology and Therapeutics, Hetero Healthcare Ltd, Sy. no 83/1, Plot Nos. 16/A/1 and 16/A/2
19th and 20th Floor, Hetero Tower, Commerzone, Madhapur.
Hyderabad
TELANGANA
500081
India |
| Phone |
9704416425 |
| Fax |
|
| Email |
shobhaudutha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr U Shobha Jagdish Chandra |
| Designation |
Head of Department (HOD) |
| Affiliation |
Hetero Healthcare Limited |
| Address |
Dept. of Clinical Pharmacology and Therapeutics, Hetero Healthcare Ltd, Sy. no 83/1, Plot Nos. 16/A/1 and 16/A/2
19th and 20th Floor, Hetero Tower, Commerzone, Madhapur.
Hyderabad
TELANGANA
500081
India |
| Phone |
9704416425 |
| Fax |
|
| Email |
shobhaudutha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hetero Healthcare Limited Sy no 83 1 Plot Nos. 16 A 1 16 A 2 19th 20th Floor Hetero tower Commerzone Silpa Gram Craft Village Madhapur Hyderabad Telangana 500081 India
|
|
|
Primary Sponsor
|
| Name |
Hetero Healthcare limited |
| Address |
Hetero Healthcare Limited Sy no 83 1 Plot Nos. 16 A 1 16 A 2 19th 20th Floor Hetero tower Commerzone Silpa Gram Craft Village Madhapur Hyderabad Telangana 500081 India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jasmina begum |
All India Institute of Medical Sciences Bhubaneswar |
Department of Obstetrics and Gynaecology All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar-751019 Odisha India
Khordha
ORISSA |
9443392737
jasminaaly@gmail.com |
| Dr V Mary Snygdha |
Government General Hospital ACSR Government Medical College |
Department of OBST and Gynaecology ASCR Government Medical College Hospital Sri Potti Sriramulu Nellore 524004 andhra pradesh India.
Nellore
ANDHRA PRADESH |
7981034760
Snygdhamaryacsrgmc@gmail.com |
| Dr Revu Subhashini |
Government General Hospital Guntur |
Ground floor labour Room department of Gynaecology Government general Hospital Railpet Guntur 522001 Andhra Pradesh India
Guntur
ANDHRA PRADESH |
8019528508
subhashinirevu@gmail.com |
| Dr B S Girija |
Hassan Institute of Medical Sciences |
Department of Obstetrics and Gynaecology Room No 27 Ground floor Sri Chamarajendra Hospital Campus Krishnaraja Pura Hassan Karnataka 573201 India
Hassan
KARNATAKA |
9945462077
girijaprasannaobg@gmail.com |
| Dr Savitri Somasekhar |
Kurnool Medical college and Government General Hospital |
Department of Obstetrics and Gynaecology 4th floor Room No 2 Budhawara Peta Kurnool 518002 Andhra Pradesh India
Kurnool
ANDHRA PRADESH |
9703377188
drsavitrisomasekhar@gmail.com |
| Dr Archana Anilkumar Bhosale |
Lokmanya Tilak Municipal Medical College and General Hospital |
Department of Obstetrics and Gynecology Sion Mumbai 400022 Maharashtra India
Mumbai
MAHARASHTRA |
9867168656
aabhosale2006@gmail.com |
| Dr Malathi Verabelly |
Malla Reddy Hospital |
Malla Reddy Clinical Research Unit (MRCRU) Room No 2A2 2nd floor L Shape building Jeedimetla Suraram
Hyderabad 500055 telangana India.
Hyderabad
TELANGANA |
9291279091
Malathi1174@gmail.com |
| Dr Theerpally Jaya |
Modern Government Maternity Hospital |
Department of OB & Gynaecology Petlaburj Hyderabad-500064 Telangana India
Hyderabad
TELANGANA |
7569243422
Jayareddy2010@gmail.com |
| Dr Shubhangi Shahare |
Saikrupa Hospital |
Plot no 4 14 B sector 34 2nd floor Renuka corner Tapkir Chowk Thergaon Pune Maharashtra 411033 India
Pune
MAHARASHTRA |
9420697279
drshubhangi2@gmail.com |
| Dr Prema Priya G |
Vinayaka Mission’s Kirupananda Variyar Medical College & Hospitals |
Room No 1 ground floor department of obstetrics and Gynaecology Sankari Main Road ChinnaSeeragapadi Salem – 636308 India
Salem
TAMIL NADU |
9976904850
dr.premapriya.r@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (MRIMS) Malla Reddy Institute of Medical Sciences, Hyderabad Telangana. |
Approved |
| Institutional Ethics Committee AC Subba Reddy Government Medical College and Hospital Nellore Andhra pradesh |
Approved |
| Institutional Ethics Committee Kurnool Medical College / Government General Hospital Kurnool Andhra pradesh |
Approved |
| Institutional Ethics Committee Lokmanya Tilak. Dr Babasaheb Ambedkar Road Maharashtra. |
Approved |
| Institutional Ethics Committee faculty research AIIMS Bhubaneswar AIIMS BBSR Sijua P/o Patrapada Bhubaneswar Khordha orissa-751019 India |
Approved |
| Institutional Ethics Committee Guntur Medical College Kannavarithota Guntur Andhra Pradesh |
Approved |
| Institutional Ethics Committee Osmania Medical College Koti Hyderabad 500095 Telangana India |
Approved |
| Institutional Ethics Committee – HIMS Hassan Hassan Institute Of Medical Sciences District Hospital Hassan Karnataka. |
Approved |
| Saikrupa Hospital Institutional Ethics Committee Saikrupa Hospital Renuka Corner Tapkir Chowk Thergaon Pune Pune Maharashtra |
Approved |
| VMKV Medical College and Hospitals VMKV Medical College and Hospitals Sankari Main Road Chinna Seeragapadi Salem Salem Tamil Nadu 636308 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B373||Candidiasis of vulva and vagina, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Canesten V6 vaginal tablet |
Dose:100mg Vaginal Tablet
Route of administration: Intravaginal
Frequency: One Canesten V6 vaginal tablet(100mg), intravaginally during nighttime for 7 days.
|
| Intervention |
Tioconazole Vaginal film |
Dose: 300mg vaginal film
Route of administration: intravaginal
Frequency: One Tioconazole vaginal film (300mg) intravaginally during nighttime for One day.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Women aged 18 to 45 years with clinical diagnosis of symptomatic vulvovaginal candidiasis
2.Subjects with positive baseline potassium hydroxide (KOH) wet mount from a vaginal smear revealing filamentous hyphae or pseudo hyphae or budding yeast cells
3.Presence of more than 1 vulvovaginal sign (erythema, Edema, excoriation), presence of more than 1 vulvovaginal symptom (itching or pruritus, irritation in and around vagina, burning; composite severity score of greater than 7
4.Patients with negative whiff test
5.Patients with vaginal pH less than 4.5
6.Agree to abstain from intercourse during the study period
7.Agree not to douche or use any intravaginal products during the study period
8.Willing to report response to treatment as per protocol during the study period
9.Willing to give written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Post menopausal women
2. Menstruating at diagnosis
3. Pregnancy or nursing mothers
4. Use of intravaginal pessaries, corticosteroids, immune suppressive, immunostimulant therapy in the last 2 weeks Presence of another vaginal condition, cervical cancer
6. History of hypersensitivity to study medication, serious illness
7. Patients with uncontrolled Diabetes mellitus
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
-Proportion of patients with clinical cure - defined as resolution or improvement of clinical signs and symptoms pertaining to VVC at the end of day 7 in each treatment group.
-Proportion of patients with mycological cure – negative potassium hydroxide (KOH) wet mount from vaginal smear for filamentous hyphae / pseudo hyphae or budding yeast cells at the end of day 7 in each treatment group.
-Proportion of patients with Therapeutic cure – defined as clinical and mycological cure at end of day 7 in each treatment group.
|
Day 7,14
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment emergent adverse events (TEAEs) |
Day 7,14. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
28/10/2025 |
| 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="0"
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
|
| Design: Open-label, randomized,
parallel-group, prospective, multicentric clinical trial. Objectives: To evaluate the clinical efficacy
and safety of Tioconazole Vaginal Film 300 mg compared to Canesten V6 Vaginal
Tablet in treating symptomatic vulvovaginal candidiasis (VVC) in non-pregnant
women. Treatment Regimen Tioconazole
Vaginal Film 300 mg:
Single-dose administration. Canesten
V6 Vaginal Tablet:
Daily administration for 7 consecutive days. Safety
Follow-up:
Conducted up to Day 14 post-treatment. Primary Outcomes Clinical
Cure: Proportion
of patients with resolution or improvement of clinical signs and symptoms of
VVC at Day 7. Mycological
Cure: Proportion
of patients with negative potassium hydroxide (KOH) wet mount from vaginal
smear for filamentous hyphae, pseudo hyphae, or budding yeast cells at Day 7. Therapeutic
Cure: Proportion
of patients achieving both clinical and mycological cure at Day 7. Secondary Outcome
Treatment-Emergent
Adverse Events (TEAEs):
Incidence of adverse events occurring during the treatment period, assessed at
Days 7 and 14. |
|