| CTRI Number |
CTRI/2023/04/051978 [Registered on: 26/04/2023] Trial Registered Prospectively |
| Last Modified On: |
25/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative study between castor oil EMULGEL with clotrimazole vaginal tablet in the treatment of subjects with vulvo-vaginal candidiasis. |
|
Scientific Title of Study
|
An open label, randomized, parallel group, comparative study to evaluate efficacy and safety of castor oil EMULGEL compared to clotrimazole vaginal tablet in the treatment of subjects with vulvo-vaginal candidiasis. |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2022/145_Version1_Dated 16/09/2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pramila Yadav |
| Designation |
Professor |
| Affiliation |
D.Y.Patil University- School of Medicine |
| Address |
Room no:2, Department of Pharmacology, 5th floor, D.Y.Patil University- School of Medicine, Sector-5, Nerul, Navi Mumbai, 40070
Navi Mumbai, Maharashtra
Thane
MAHARASHTRA
400706
India |
| Phone |
9820792968 |
| Fax |
|
| Email |
drpramilayadav10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sayali Patil |
| Designation |
1st year PG resident, Department of Pharmacology |
| Affiliation |
D.Y.Patil University- School of Medicine |
| Address |
Department of Pharmacology,
5th floor, D.Y.Patil University- School of Medicine
Sector-5, Nerul
400706
India
Navi Mumbai, Maharashtra
Thane
MAHARASHTRA
400706
India |
| Phone |
9158960386 |
| Fax |
|
| Email |
patilsayali5796@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayali Patil |
| Designation |
1st year PG resident, Department of Pharmacology |
| Affiliation |
D.Y.Patil University- School of Medicine |
| Address |
5th floor,
Department of Pharmacology,
D.Y.Patil University- School of Medicine
Sector-5, Nerul
Navi Mumbai, Maharashtra
Thane
MAHARASHTRA
400706
India
Navi Mumbai, Maharashtra
Thane
MAHARASHTRA
400706
India |
| Phone |
9158960386 |
| Fax |
|
| Email |
patilsayali5796@gmail.com |
|
|
Source of Monetary or Material Support
|
| D.Y.PATIL UNIVERSITY-SCHOOL OF MEDICINE, NAVI MUMBAI |
| ORIENTAL COLLEGE OF PHARMACY, SANPADA |
|
|
Primary Sponsor
|
| Name |
D Y Patil University School of Medicine Navi Mumbai |
| Address |
SECTOR-5, NERUL, NAVI MUMBAI- 400706 |
| Type of Sponsor |
Private medical college |
|
|
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 SAYALI PATIL |
D.Y.Patil Hospital |
Gyneacology OPD, First floor, D.Y.Patil Hospital, SECTOR-5, NERUL, NAVI MUMBAI, 400706
Thane
MAHARASHTRA |
9158960386
patilsayali5796@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECBH D.Y.PATIL MEDICAL COLLEGE, NAVI MUMBAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N760||Acute vaginitis. Ayurveda Condition: KAPAJA-YONIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | CLOTRIMAZOLE | 200 mg clotrimazole vaginal tablet once daily for 3 days intravaginal regimen | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Castor oil EMULGEL, Reference: NA, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 50(mg), Frequency: bd, Bhaishajya Kal: Grasa bhakta/Sagrasa, Duration: 5 Days, anupAna/sahapAna: Yes(details: -), Additional Information: Cator oil EMULGEL will be applied topically in the vagina twice daily for a period of 5 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patients in reproductive age group (18-45 years).
2. Patients willing to give written informed consent.
3. Patients with clinical signs and symptoms of vulvovaginal candidiasis (complaints of vaginal pruritus, burning sensation, vulvar soreness or thick curdy discharge).
|
|
| ExclusionCriteria |
| Details |
1. Pregnant or lactating women.
2. Patients with history of previous treatment with systemic antifungal agents within past four weeks or previous topical antifungal treatment within one week.
3. Having any sexually transmitted disease or gynecological abnormality requiring treatment.
4. History of diabetes mellitus or other chronic illness.
5. Immunocompromised patients or patients on immunosuppressant therapy.
6. Presence of concomitant vaginitis caused by other infections (e.g., Bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis or Neisseria gonorrhea).
7. Hypersensitivity to azoles or any component of the formulation.
8. History of drug or alcohol dependency or abuse.
9. Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or scheduled to do the same during the course of this study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical cure rate (proportion of participants achieving clinical cure) |
At baseline, Day-4 for Clotrimazole 200mg & Day 6 for Castor oil EMULGEL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Microbiological cure rate (Direct microscopy/wet smear): Number of positive findings in direct microscopy in comparison to first visit.
2. Therapeutic cure rate: Clinical and microbiological cure combined.
3. Total Severity Score (TSS): Individual clinical signs and symptoms.
4. Vaginal pH: Mean vaginal pH in comparison to first visit.
5. Patients satisfaction: Patient will be asked how satisfied she was with the treatment received based on 8 standardized questions.
|
Castor oil EMULGEL- Day-0 First visit- Day-6 end of treatment.
Clotrimazole 200mg - Day-0 First visit- Day-4 end of treatment. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/05/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - patilsayali5796@gmail.com
- For how long will this data be available start date provided 01-05-2023 and end date provided 01-12-2023?
Response (Others) - 6 months
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized, open label,
comparative, parallel-group trial comparing the safety and efficacy
of castor oil EMULGEL compared to clotrimazole 200mg vaginal tablet in the
treatment of 80 subjects with vulvo-vaginal candidiasis that will be
conducted at D.Y.Patil Hospital, Navi Mumbai. The primary outcome measures will
be therapeutic cure at follow up visit (Day 4 for clotrimazole and Day 6 for
castor oil). The secondary outcomes will be: 1. Microbiological cure rate (Direct
microscopy/wet smear): Number of positive findings in direct microscopy in
comparison to first visit. 2. Therapeutic cure rate: Clinical and
microbiological cure combined. 3. Total Severity Score (TSS): Individual clinical
signs and symptoms.
|