| CTRI Number |
CTRI/2024/05/068227 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clotrimazole treatment in vaginal fungal Infections |
|
Scientific Title of Study
|
A Randomized, Open label, Comparative clinical study to compare and evaluate
Efficacy and Safety of the Candimilt 500 soft gelatin vaginal capsules
containing Clotrimazole 500 mg and the Candid V3 vaginal tablets containing
Clotrimazole 200 mg in patients with Vulvovaginal Candidiasis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CANDID/010/22 Ver 1.1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uthpala Vadakaluru |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College |
| Address |
Room no 5, Department of Obsttetrics ang Gynaecology, Mahatma Gandhi Medical College and Research Institute, Pondicherry.
Pondicherry
PONDICHERRY
607403
India |
| Phone |
7013208734 |
| Fax |
|
| Email |
druthuv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uthpala Vadakaluru |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Medical College |
| Address |
Room no 5, Department of Obsttetrics ang Gynaecology, Mahatma Gandhi Medical College and Research Institute, Pondicherry.
Pondicherry
PONDICHERRY
607403
India |
| Phone |
7013208734 |
| Fax |
|
| Email |
druthuv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
KI3 Private Limited |
| Address |
Room no. 1, Office of the Director, Clinical Trial Department, Regus Office Centre Services (Chennai) Pvt Ltd. Olympia Technology Park, Level - 2, Altius Block, No -1, SIDCO Industrial Estate, Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
drgayathri@ki3services.com |
|
|
Source of Monetary or Material Support
|
| Miltonia Health Science Ltd, 1st Floor. 14, Bowling Green Lane, London, United Kingdom |
|
|
Primary Sponsor
|
| Name |
Miltonia Health Science Ltd |
| Address |
1st Floor. 14, Bowling Green Lane, London, United Kingdom |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Uthpala Vadakaluru |
Mahatma Gandhi Medical College and Research Institute |
Room no. 5, Department of Obstetrics and Gynaecology, MGMC&RI, Pillayarkuppam, Pondicherry
Pondicherry
PONDICHERRY |
7013208734
druthuv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Medical College and Research Institute- Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Candid V3® vaginal tablets containing Clotrimazole 200 mg
once daily for 3 days |
200 mg dosed vaginally for 3 Consecutive days |
| Intervention |
Candimilt® 500 vaginal capsules
Single use as STAT dose |
Single STAT dose 500 mg (Single use) vaginally on day 1 alone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Women with the symptoms of vulvovaginal candidiasis (based on
symptoms and signs after speculum examination);
1. Non-pregnant female patients aged 18 years and above and clinically
diagnosed with vulvovaginal candidiasis were included;
2. Capable of giving written informed consent and willing to follow the
investigational study procedures and report AEs.
3. Subjects must not be on their menstrual period on the day of screening
and do not anticipate their period to begin during treatment (3 days);
4. Subjects must be using an acceptable method of birth control, willing
to refrain from sexual intercourse from the date of screening until the
follow-up visit (approximately 7 days later);
5. Willing to refrain from the use of any intravaginal/ vulvovaginal
products (douches, spermicidal foams or gels, vaginal lubricants, etc)
from the screening visit until the follow up visit;
6. Patients who have complaint of abnormal vaginal odour with or
without complaints of discharge and those were not treated for
bacterial vaginosis, intra-vaginal or oral anti-fungal medications or
antibiotics, within the last 14 days of enrolment;
7. Patients must abstain from alcohol ingestion during the treatment
period and for one day afterward |
|
| ExclusionCriteria |
| Details |
1)usage of any topical or systemic medication, particularly antimicrobial agents over a 30-day period prior to the start of the investigation
2)positive pregnancy test at screening
3)Previously diagnosed with (HIV) infection, having visible vaginal or cervical mass suspected cancer, and within six weeks of post-abortion or postpartum
4) Women who are currently or who will require treatment with anticoagulants, lithium, disulfiram, or neuromuscular blocking agents
5)breastfeeding
6)Study will also exclude patients with history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition7) Patients with a history of seizure disorders
8)Patients with renal impairment 9) Patients with hepatic impairment10) History of uncontrolled Diabetes Mellitus and hypertension
11)Inability to comply with the protocol requirements
12)Participation in any other clinical trial within 3 months of registering in this trial
13)Patients receiving diuretics or related medicines;14)Post-menopausal women/Menstruating at the time of diagnosis; 15)Use of oral or intravaginal antibiotics within the past 2 weeks;
16)Immunosuppressive drug within 4 months
17)Presence of vaginal / vulval ulcer any other vulval, vaginal or medical condition, including cervicalneoplasia/ treatment that might confound treatment response
18)Inability to keep return appointments19) History of hypersensitivity to clotrimazole, clindamycin or lincomycin or any excipient in the drug formulation regional enteritis, ulcerative colitis or ‘antibiotic associated’ colitis 20) Intrauterine device
|
|
|
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 |
1) Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for candidal vaginitis
2) Clinical Response
3) Number of patients achieving improvement in scores for quantity of vaginal discharge by at least 1 unit from baseline
4) Improvement or resolution of local signs of inflammation
5) A vulvovaginal symptoms questionnaire (VSQ) will be done at baseline and end of study
6) Changes from baseline to 4- weeks in Quality of Life Questionnaires
7) Photographic assessment of improvement and test product dissolution status
8) Microbiological cure - evaluation : microscopy of vaginal discharge smears will be done on baseline and on day 7 and 14 |
DAy 7, 14 and 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The secondary endpoint of the study is to assess the safety of subjects enrolled in the intent-to- treat (ITT) population who achieve therapeutic cure by monitoring Adverse drug reactions and laboratory abnormalities if any from baseline to post study on day 28.
|
Baseline and Post study on day 28. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
10/12/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Adult human females (non-pregnant & non-lactating) with the age limit of greater than or equal to 18 years, diagnosed to be suffering from vulvovaginal candidiasis will be included in the present study and efficacy and safety of the Candimilt 500 vaginal capsules containing Clotrimazole 500 mg produced for Miltonia Health Science Ltd, United Kingdom will be evaluated in comparison with Candid V3 vaginal tablets containing Clotrimazole 200 mg
Primary Outcome
1) Number of patients showing resolution of clinical signs suggestive of infective vaginitis and a vaginal swab that is negative for candidal vaginitis 2) Clinical Response (Time frame : at 7th and 14th after start of treatment) 3) Number of patients achieving improvement in scores for quantity of vaginal discharge by at least 1 unit from baseline 4) Improvement or resolution of local signs of inflammation 5) A vulvovaginal symptoms questionnaire (VSQ) will be done at baseline and end of study 6) Changes from baseline to 4- weeks in Quality of Life Questionnaires 7) Photographic assessment of improvement and test product dissolution status 8) Microbiological cure - evaluation : microscopy of vaginal discharge smears will be done on baseline and on day 7 and 14 |