| CTRI Number |
CTRI/2025/11/096926 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Yoni dhoopana and Yoni kalkadharana] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A study comparing Brhatiphaladi yoni kalkadharana and yoni dhoopana in the treatment of vaginal yeast infection |
|
Scientific Title of Study
|
A Comparative Clinical Trial on the Effectiveness of Brhatiphaladi Yoni Kalkadharana against Yoni Dhoopana in Vulvovaginal Candidiasis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhisha |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of Prasuti Tantra and Streeroga, Government Ayurveda College Tripunithura Ernakulam, Kerala
Ernakulam
KERALA
682301
India |
| Phone |
9961117603 |
| Fax |
|
| Email |
abhishakrajan27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahina Mole S |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of Prasuti Tantra and Streeroga, Government Ayurveda College Tripunithura Ernakulam, Kerala
Ernakulam
KERALA
682301
India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shahina Mole S |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department of Prasuti Tantra and Streeroga, Government Ayurveda College Tripunithura Ernakulam, Kerala
Ernakulam
KERALA
682301
India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Tripunithura, Ernakulam, Kerala, India, pin code :682301 |
|
|
Primary Sponsor
|
| Name |
Abhisha K |
| Address |
PG Scholar, Department of Prasuti Tantra and Streeroga, Government Ayurveda College, Tripunithura, Ernakulam, Kerala, Pin code : 682301 |
| Type of Sponsor |
Other [Self] |
|
|
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 Abhisha K |
Government Ayurveda College Tripunithura |
Department of Prasuti Tantra and Streeroga, Government Ayurveda College, Tripunithura, Ernakulam, Kerala, Pin code : 682301
Ernakulam
KERALA |
9961117603
abhishakrajan27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Committee for Ethics in Research (Institutional Review Board), Govt. Ayurveda College,Tripunithura, Kochi, Kerala-682301 |
Approved |
| Institutional Committee for Ethics in Research (Institutional Review Board), Govt. Ayurveda College,Tripunithura, Kochi, Kerala-682301 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:B373||Candidiasis of vulva and vagina. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | dhUpana, धूपन | (Procedure Reference: susruta samhita yonivyapat chikitsa, Procedure details: POORVA KARMA
Dhoopana apparatus containing pre-heated electric coil will be kept ready
Patient will be advised to empty the urinary bladder
Patient will be made to lie in supine position with knee flexed and thighs abducted
Routine gynaecological examination will be done.
PRADHANA KARMA :
After taking aseptic precautions , sterilized Cusco’s Bivalve speculum will insert into the
vagina to visualize the cervix.
Cervix will cleanse properly with cotton swab soaked in distilled water by using a sponge
holding forceps.
The Brhatiphaladi choorna will be added in to the dhoopana apparatus so as to produce
dense fumes
The tip of the tube of the apparatus will be kept 3-5 cm away from the vaginal introitus
The fumes reach the vagina by passing through the tube of the apparatus
The fumes will be administered for 3-5 minutes in to the vagina
After removing Cusco’s Bivalve speculum, fumes from the apparatus will be administer
to the vulval area for 3-5 minutes
PASCHAT KARMA:
Patient will be advised to take rest for 1 hour in supine position. Patient will be advised to wash the area with lukewarm water)
(1) Medicine Name: Brhatiphaladi churnam, Reference: susruta samhita yonivyapat chikitsa, Route: Vaginal, Dosage Form: Churna/ Powder, Dose: 15(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | yoni pUraNa , योनि पूरण | (Procedure Reference: Susruta samhita uttaratantra 38/27, Procedure details: Procedure method Preparation of patient - Patient will be advised to empty the urinary bladder. Patient will be made to lie in supine position with knee flexed & thighs abducted. Routine gynaecological examination will be done.
Pradhana karma - Antiseptic painting of vulva & vaginal draping is done. After taking aseptic precautions, sterilized Cusco’s Bivalve speculum will insert into the vagina to visualize the cervix. Cervix will cleanse properly with cotton swab soaked in distilled water by using a sponge holding forceps. The sterile Kalka Pichu will gently introduce into the cervix. The thread of Pichu will be left out of the vagina for easy removal. After removing Cusco’s Bivalve speculum, patient will be advised to keep the Pichu until she feels urge of micturition.
Paschat karma - Patient is advised to wash the area with lukewarm water
)
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Participants of age group 25- 45 years with Vulvovaginal candidiasis having complaints of thick curdy white vaginal discharge and vulvovaginal pruritis
2.Who are competent and willing to give written informed consent |
|
| ExclusionCriteria |
| Details |
1.Unmarried
2.Pregnancy
3.Uncontrolled Diabetes mellitus
4.Pelvic inflammatory disease
5.Infectious disorders of genital tract like HIV, Hepatitis B, Syphilis
6.Patients undergoing prolonged medication for various systemic illnesses
7.Dysfunctional uterine bleeding
8.Cervical lesions
9.Known case of malignancies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Candidal colony count by vaginal swab culture using Sabouraud’s media |
1 week atter treatment and 4 weeks after study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Assessment of thick curdy-white vaginal discharge using Likert scale & scoring pattern
2.Assessment of Vulvovaginal pruritis using Likert scale & scoring pattern |
1 week, 4 week |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/11/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Vulvovaginal candidiasis is the second most common vulvovaginal infection after Bacterial vaginosis caused by gram-positive yeast like fungus, Candida albicans. The disease is characterised by intense vulvar pruritus, thick curdy white cottage cheese like vaginal discharge, vaginal soreness, erythema, dysuria and dyspareunia.Symptomatically vulvovaginal candidiasis resembles with Slaishmiki yonivyapat in Ayurveda, which is characterised by pandu-pichila-seeta srava along with kandu and alpavedana or avedana. Brhatiphaladi yoni poorana and dhoopana is mentioned by Susruta Acharya in Uttaratantra Yonivyapat pradisheda adhyaya with an indication of yoni kandu and alpasparsa yoni are selected for the study.The study design is a non-randomised clinical trial, with a sample size of 18 per each group. Subjects aged 25 - 45 years, diagnosed with vulvovaginal candidiasis having thick curdy white vaginal discharge and vulvovaginal pruritis following the inclusion and exclusion criteria will be taken for the study. Data collection will be done by clinical observation through case proforma and relevant investigations will also be done. The medicine will be administered on the following basis. Participants are allocated to Group A and Group B. For trial group-A, Brhatiphaladi yoni kalkadharana for 7 days in the follicular phase will be given. Whereas for trial group-B, Brhatiphaladi yoni dhoopana for 7 days in the follicular phase will be given. Lodhradi gana kwatha will be given to both the trial group as the conventionally used internal medication. The assessment parameters include colony count in culture for Candida species, Likert scale and scoring pattern for assessing symptoms of Vulvovaginal candidiasis. Assessment will be done on the 0th, 8th and 31st day. All the necessary investigations required will be done in the study setting. Vaginal swab culture for Candidal colony counts using Sabouraud’s media will be done in the Microbiology laboratory. Results will be statistically analysed and summarised to arrive at conclusions.
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