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临床试验/CTRI/2025/04/085360
CTRI/2025/04/085360尚未招募3 期

Effect of Khadira suppository in the management of Upapluta Yoni Vyapath vis-a-vis vulvovaginitis in pregnancy-An open label standard controlled clinical study

Dr Sudharani1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
The effect of Khadira suppository in upapluta Yoni Vyapad.

研究概览

简要总结

Vulvovaginitis can be understand in Ayurveda with reference to Upapluta Yonivyapad. Itis one among 20 Yonivyapad described by Acharya Charakaand both Vagbhata. Meaning of word Upapluta means over flowed, invade or afflicted.According to Ayurveda if women during pregnancy take Kapha aggravating Ahara and Vihara excessively and suppresses the urges of vomiting and respiration, the vitiated Vayu carries Kapha  to genital tract and affect the same, because of this, white mucus discharge along with pain occurs. There is prevalence of Kapha and Vata Rogas, termed as Upapluta Yonivyapad.

Vulvovaginitis or vaginitis, is frequently cited as the most common reason that women visit their   primary care providers for a gynecologic-related diagnosis. It is defined as inflammation or infection of vagina, Vaginitis presents a spectrum of symptoms, including itching, burning, irritation, dyspareunia, vaginal odor, and abnormal vaginal discharge. The most common causes are Bacterial vaginosis, Vulvovaginal candidiasis, and Trichomoniasis.

Pregnancy is a immunocompromised state where there will be high chances for inflammation including vulvovaginitis. It occurs frequently during pregnancy because of altered vaginal flora. Vaginal infections are risk factors for premature rupture of membranes. Hence treating vaginal infections should done in priority along with regular antenatal care. Modern science has good treatment for Vulvovaginitis (local and oral). There is a need of good approach through Ayurveda.

Acacia catechu commonly known as Catechu is a medicinal plant used for varied purposes. The bark  of this plant is strong, antioxidant, astringent, antibacterial, anti-fungal, anti-viral and anti-inflammatory in nature.

Becomes because of its Tikta and Kashaya Rasa acts as Sthambhana, Kushtaghna and Krimighna.

Bark of Khadira has Kushtaghna and Kandughna properties.

Mainly used in Pradara and Yonishaithilya.

Khadira exhibits anti-bacterial and antifungal attributes, effectively impending the proliferation of bacteria and fungi, responsible for skin problems. The application or washing of affected area with Khadira Kwatha contributes to reducing inflammation and arresting bleeding, this is attributed to its Kashaya, Ropana and Krimighna properties.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
19.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • 1.Pregnant women between the age group of 19 to 35 years, subjects having clinical features such as vaginal discharge, vulvar itching, burning sensation in vagina, pain in vagina, foul smell in vagina.
  • 2.Pregnant women with irrespective of parity between 8 to 28 weeks of gestation 3.On pelvic examination inflammation Of vulva and vagina.

排除标准

  • 1.Pregnant women with known case of medical disease such as Diabetes mellitus, hypertension, thyroid abnormalities, any organic pathology or hepatic, cardiac, renal disease or any acute infection.
  • 2.Known case of Obstetric complications such as placenta Previa, cervical insufficiency and twin pregnancy.
  • History of previous abortion and known case of threatened abortion.
  • History of sexually transmitted diseases and known case of Human Immunodeficiency Virus.
  • Known case of congenital vaginal anomalies.

结局指标

主要结局

The effect of Khadira suppository in upapluta Yoni Vyapad.

时间窗: 1 week

The effect of clingen forte vaginal capsule in vulvovaginitis during pregnancy

时间窗: 1 week

The efficacy of Khadira suppository versus clingen forte vaginal capsule in vulvovaginitis during pregnancy

时间窗: 1 week

次要结局

  • To determine the disintegration time of trial suppository.(1 hour)

研究者

发起方
Dr Sudharani
申办方类型
Private medical college

研究点 (1)

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