| CTRI Number |
CTRI/2025/03/082459 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To know the effect of ayurvedic drug Guduchiyadi yoni varti(Guduchi etc drug vaginal suppository) and contemporary drug Candid-CL vaginal suppository in the treatment of white discharge per vagina |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the effectiveness of Guduchiyadi yoni varti and Candid-CL vaginal suppository in the Kaphaja yoni vyapat with special reference to Vaginal 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 |
Dr Gowsiga N |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Prasoothi tantra and Stree roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B.M Road, Thanniruhalla, Hassan, Karnataka- 573201.
Hassan
KARNATAKA
573201
India |
| Phone |
8056827027 |
| Fax |
|
| Email |
gowsigalishalini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prathima |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Prasoothi tantra and Stree roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B.M Road, Thanniruhalla, Hassan, Karnataka- 573201.
Hassan
KARNATAKA
573201
India |
| Phone |
9611990497 |
| Fax |
|
| Email |
drprathima.jain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prathima |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Prasoothi tantra and Stree roga, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B.M Road, Thanniruhalla, Hassan, Karnataka- 573201.
KARNATAKA
573201
India |
| Phone |
9611990497 |
| Fax |
|
| Email |
drprathima.jain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, B.M Road, Thanniruhalla, Hassan, Karnataka, India. Phone No- 08172256460, Email- sdmcah@gmail.com
|
|
|
Primary Sponsor
|
| Name |
Dr Gowsiga N |
| Address |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, B.M Road, Thanniruhalla, Hassan, Karnataka |
| 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 Gowsiga N |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan |
OPD IPD, Department of Prasoothi tantra and Stree roga
Hassan
KARNATAKA |
8056827027
gowsigalishalini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N768||Other specified inflammation of vagina and vulva. Ayurveda Condition: KAPAJA-YONIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Guduchiyadi yoni varti, Reference: Basavarajeeyam, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Candid- CL Vaginal suppository | DOSE- 1
FREQUENCY- ONCE A DAY
ROUTE OF ADMINISTRATION- PER VAGINAL
TOTAL DURATION- 7 DAYS |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects full filling the diagnostic criteria
2. Married women between the age group of 21-45 years
3. Willing to co-operate with the study and sign the informed written consent form
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women
2. Women with K/C/O Pelvic inflammatory disease
3. Women with K/C/O Cervical intraepithelial neoplastic lesions
4. Subjects positive for HIV, VDRL, HBsAG
5. Diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from curdy white discharge, vulval and vaginal itching |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence of curdy white discharge, vuval & vaginal itching |
14 days |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
25/03/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
Vaginal candidiasis is one of the most common vaginal infections. Candidiasis is fungal infection caused by Candid albicans, a polymorphic opportunistic fungus. Vaginal candidiasis is representing 40 percent to 50 percent of all cases of infectious vulvovaginitis. Between 70 percent and 75 percent of sexually active women will experience at least one episode of vaginal candidiasis in their lifetime and 5 percent to 8 percent of adult women have recurrent disease, defined as four or more episodes per year. Symptoms of vaginal candidiasis include abdominal vaginal discharge, pruritus, vaginal soreness and dysuria. Signs include vulvar edema, fissure, excoriations and thick curdy vaginal discharge. Kaphaja yoni vyapat is caused by aggravated kapha along with abnormal function of vata, which reaches the reproductive organs of women results in kandu, sheeta picchila srava, manda ruja and pandu varna. Sthanika chikitsa is given more importanceas it directly acts on the site and helps in faster recovery. Yoni varti is mentioned for the management of Kaphaja yoni vyapat due to its ruksha and ushna guna which acts opposite to snigdha, picchila and sheeta guna of kapha. The drugs of Guduchiyadi yoni varti has katu, tikta, kashaya, laghu, ruksha, tiksna guna, ushna virya, katu vipaka and kaphakara properties which tend to reduce kandu, shweta and picchila yoni srava. Clotimazole is the drug of choice for vaginal candidiasis, Candid-CL vaginal suppository is taken for study. In total, 37 articles assessed the effectiveness and safety of tropical Clotriamazole in the treatment of uncomplicated(acute) and complicated Vaginal candidiasis, single tropical doses of a Clotrimazole 500 mg vaginal tablets provided mucological cure rates of upto 95 percent. In recurrent symptomatic Vaginal candidiasis, Clotrimaole induction treatment for 0ne to two weeks resulted in short-term mycological cure rated of less than 80 percent and tropical treatments applied intermittently(monthly) prevented disease recurrence and breakthough vaginitis in upto 70 percent. Hence, in Kaphaja yoni vyapat, Guduchiyadi yoni varti and Candid-CL vaginal suppository is taken for study. |