An Open Label Randomized Controlled Clinical Study To Evaluate The Effect Of Takradi Yoga Yoniprakshalana In The Management Of Kaphaja Yoni Vyapat Vis-A-Vis Vulvovaginal Candidiasis
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
Study Overview
Brief Summary
This study is an open-label randomized controlled clinical trial designed to evaluate the efficacy of Takradi Yoga Yoni Prakshalana in the management of Kaphaja Yonivyapad, correlated with Vulvovaginal Candidiasis, and to compare its effect with the standard modern treatment Clotrimazole (1 Percent) vaginal gel.
Kaphaja Yonivyapad, described in Ayurveda under Vimshati Yonivyapad, is characterized by Picchila Srava (thick discharge), Yoni Kandu (itching), , and Dourgandhya (foul smell) , which closely resemble the clinical features of vulvovaginal candidiasis caused predominantly by Candida albicans. Despite the availability of antifungal therapy in modern medicine, issues such as recurrence, resistance, and side effects necessitate safer and holistic alternatives.
Ayurveda emphasizes Sthanika Chikitsa (local treatment) along with Kapha-Vata hara principles. Classical references support Yoni Prakshalana using Takra, Triphala Kwatha, and Gomutra Arka, which possess Kaphaghna, Kandughna, Krimighna, and Shothahara properties. The prepared Takradi Yoga maintains a mildly acidic pH (5–6), favorable for restoring vaginal flora.
A total of 40 married women aged 18–45 years, diagnosed with vulvovaginal candidiasis, will be randomly allocated into two groups:
Group A (Control): Clotrimazole (1 Percent) vaginal gel for 7 days
Group B (Intervention): Takradi Yoga Yoni Prakshalana for 7 days
Assessment will be done based on subjective parameters ( vaginal discharge, itching, foul smell) and objective parameters (vulval changes, Quanatity of discharge, vaginal smear positivity for Candida albicans), with follow-up after treatment.
The study aims to establish Takradi Yoga Yoni Prakshalana as an effective, safe, and integrative Ayurvedic local therapy for the management of Kaphaja Yonivyapad / Vulvovaginal Candidiasis
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Married women
- •Female subjects aged between 18 and 45 years.
- •Subject who fulfilling the diagnostic criteria will be taken.
Exclusion Criteria
- •1.Unmarried women 2.Known case of malignant condition.
- •3.Known case of diabetes mellitus 4.Pregnant or Lactating women 5.Those undergoing hormone replacement therapy 6.Subjects who had received oral and topical antifungal treatment or corticosteroids within the last 6 months.
Investigators
Dr Mahalaxmi
JSS Ayurveda Medical College