| CTRI Number |
CTRI/2025/09/095270 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study in women suffering from vaginal yeast infection to see whether applying an Ayurvedic oil (Udumbaradi oil) locally is as helpful as a common antifungal medicine (Clotrimazole). |
|
Scientific Title of Study
|
A randomized comparative clinical study to evaluate the effect of Udumbaradi taila pichu vs Clotrimazole vaginal tablet in the management of Shlaishmiki yonivyapad w.s.r. 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 |
Dr Kavitaben Rameshbhai Parmar |
| Designation |
Preliminary MS Ayu Scholar, Department of Prasuti Tantra Evum Stri Roga |
| Affiliation |
Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad. |
| Address |
Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad, Seeganpur, Uttar Pradesh 209601.
Farrukhabad UTTAR PRADESH 209601 India |
| Phone |
7338073537 |
| Fax |
|
| Email |
kavitasihag241219@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Nandan Shrivastava |
| Designation |
MS (Ayu) Professor, Department of Prasuti Tantra Evum Stri Roga |
| Affiliation |
Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad. |
| Address |
Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad, Seeganpur, Uttar Pradesh 209601.
Farrukhabad UTTAR PRADESH 209601 India |
| Phone |
9984604666 |
| Fax |
|
| Email |
srinandan23@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Kavitaben Rameshbhai Parmar |
| Designation |
Preliminary MS Ayu Scholar, Department of Prasuti Tantra Evum Stri Roga |
| Affiliation |
Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad. |
| Address |
Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad, Seeganpur, Uttar Pradesh 209601.
Farrukhabad UTTAR PRADESH 209601 India |
| Phone |
7338073537 |
| Fax |
|
| Email |
kavitasihag241219@gmail.com |
|
|
Source of Monetary or Material Support
|
| Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad, Seeganpur, Uttar Pradesh 209601. |
|
|
Primary Sponsor
|
| Name |
Major S.D. Singh PG Ayurvedic Medical college and Hospital. |
| Address |
Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad, Seeganpur, Uttar Pradesh 209601. |
| Type of Sponsor |
Other [Private Ayush 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 |
| DrKavitaben Rameshbhai Parmar |
Major S.D. Singh PG Ayurvedic Medical college and Hospital |
Major S.D. Singh PG Ayurvedic Medical college and Hospital, Bewar Road, Fatehgarh, Farrukhabad, Seeganpur, Uttar Pradesh 209601. Farrukhabad UTTAR PRADESH |
07338073537
kavitasihag241219@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Major S.D. Singh PG Ayurvedic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N760||Acute vaginitis. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Udumbaradi Taila Yonipichu, Reference: Charak samhita, by Dr. Harishchandra singh Kushavaha, vol 2, Published by Chaukhambha orientalia, Varanasi, Chikitsa sthana chapter no 30, yonivyapad chikitsa adhyaya, shloka no 73 to 77, page no 811., Route: Vaginal, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Clotrimazole vaginal tablet insertion | Clotrimazole 100 mg vaginal tablets of standard pharma will be taken and will be gently inserted in vagina and kept overnight.
|
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Married/Widow women aged between 18 to 45 years irrespective of caste, socio- economic
status, fulfilling the diagnostic criteria of Shlaishmiki yonivyapad.
2. Those who are willing to participate and sign a written informe consent will be included in
study.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women.
2. Hb less than 10gm percentage.
3. Patient with genital skin lesions.
4. Patient having Diabetes Mellitus.
5. Patient on contraceptive measures and barrier methods.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Picchila Yonigata srava, yonikandu,and alpavedana will be decreased. |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/10/2025 |
| Date of Study Completion (India) |
10/03/2026 |
| 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
|
In our country, factors such as poor nutrition, multiple childbirths, low socio economic status, poverty, population growth, and neglect of proper hygiene contribute to many women experiencing conditions such as anemia, malnutrition, and poor health. Consequently, they are more susceptible to various gynecological disorders, including Shlaishmiki yonivyapad. Shlaishmiki yonivyapad is a prevalent and pressing issue affecting women worldwide. Its symptoms, including vaginal white discharge, itching and mild vaginal pain, are often distressing. Through a comprehensive analysis of the chief complaints and a review of the disease, Shlaishmiki yonivyapad is compared to vulvovaginal candidiasis. While numerous treatments exist in modern science, they are not devoid of side effects and the risk of recurrence. Therefore, the selection of an appropriate treatment is paramount.
Classical texts outline a range of local treatments, including yoni varti or vaginal pessary, yoni dhavan or vaginal douching, yoni pichu or vaginal medicated oil tampon and yoni dhoopan or vaginal fumigation, alongside oral medications, yielding positive outcomes in managing various Yonivyapad. Given its widespread utilization and high effectiveness, sthanik chikitsa in the form of yoni pichu, especially Udumbaradi taila pichu, emerges as the preferred remedy for Shlaishmiki yonivyapad, thus justifying its selection for this study. Unlike other forms of candidiasis, vulvovaginal candidiasis primarily affects immunocompetent and otherwise healthy women, particularly during their child bearing years. Although non lethal, its widespread global incidence and significant negative impact on quality-of-life underscore the urgency for a deeper understanding of the disease and the development of enhanced treatment protocols. One of the most commonly utilized medicines for the treatment of Vulvovaginal candidiasis is Clotrimazole vaginal tablet, hence it has been selected for the comparative study as the standard drug.
|