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临床试验/CTRI/2025/03/082459
CTRI/2025/03/082459尚未招募2/3 期

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

Dr Gowsiga N1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年3月25日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
32
试验地点
1
主要终点
Relief from curdy white discharge, vulval and vaginal itching

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Subjects full filling the diagnostic criteria
  • Married women between the age group of 21-45 years
  • Willing to co-operate with the study and sign the informed written consent form.

排除标准

  • Pregnant and lactating women
  • Women with K/C/O Pelvic inflammatory disease
  • Women with K/C/O Cervical intraepithelial neoplastic lesions
  • Subjects positive for HIV, VDRL, HBsAG
  • Diabetes mellitus.

结局指标

主要结局

Relief from curdy white discharge, vulval and vaginal itching

时间窗: 7 days

次要结局

  • No recurrence of curdy white discharge, vuval & vaginal itching(14 days)

研究者

发起方
Dr Gowsiga N
申办方类型
Other [(self)]
责任方
Principal Investigator
主要研究者

Dr Gowsiga N

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital

研究点 (1)

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