A randomized open-labelled comparative clinical study to evaluate the efficacy of oral administration of Nimbashatka choorna and Nimba malahara lepa with Vidangadi choorna and Nimba malahara lepa in Acharana yonivyapat with special reference to pruritus vulvae
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- There is significant decrease in Pruritus vulvae which will be assessed based on 5-D Pruritus scale
研究概览
简要总结
Throughout history, the central role of women in society has ensured the stability, progress and longterm development of nations. Today, the median female shares of the global workplace is 45.4% wherein the role of women in the urban and rural workforce has expanded exponentially in recent decades. It is, therefore, important to focus on women and their health. In this regard, Ayurveda plays an important role in preserving the comprehensive wellbeing of a woman. And this study aims at targeting one such ailment in Gynaecology. Improper hygiene (Adhavana) of yoni leads to the formation of Jantu which in turn leads to excessive itching in the Yoni and this condition is termed as Acharana Yonivyapath. A similar entity in modern classics, where there is excessive itching in the vulvar region is termed as Pruritus Vulvae. Pruritus Vulvae is a symptom which is experienced by not less than 10% of women attending gynecological clinics. If not treated properly, profound itching in Vulval Pruritus leads to uncontrollable scratching, which results in conditions like Lichen simplex chronicus, now called Hyperplastic vulval dystrophy. Many modern medications like anti-fungal, antibacterial, corticosteroids, local anaesthetic agents have been in use for this condition. But they have their own side effects. In Ayurvedic classics, there are many references to treat Kandu. Among them, oral administration of Nimbashatka choornaand Vidangadi choorna is said to be effective in Pruritus Vulvae. Nimbashatka choorna contains Nimba, Kutaja, Saindhava, Hingu, Vidanga and Ramata and Vidangadi choorna with ingredients Vidanga, Triphala and Krishna are indicated in Kustha, Krimi, Meha, Nadi vrana and Bhagandara. Both the Choornas are selected for the study because of their Krimighna and Kandughna property. Nimba Malahara lepa is a topical application of medicated ointment where in the duration of drug application is more compared to lepa. Nimba being Krimihara, Kaphahara and Kandughna is the best drug of choice for Lepana. External application of Nimba added with the oral medicines facilitates easier as well as faster recovery from the symptoms. This study therefore, intends to aid diagnosis and rationalize prescribing, to find a sure shot treatment for Acharana Yonivyapath.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Female
入选标准
- •Subjects irrespective of marital status 2) Subjects in perimenopausal and post-menopausal age group 3)Subjects diagnosed with classical symptoms of Acharana yonivyapath 4)Subjects with classical symptoms of Pruritus vulvae.
- •Subjects willing to sign the consent form.
排除标准
- •1.Subjects who are pregnant and lactating mothers.
- •2.Subjects during the time of menstruation.
- •3.Subjects with uncontrolled diabetes mellitus.
- •4.Subject with known case of sexually transmitted diseases.
- •5.Subject with known case of benign and malignant conditions.
- •6.Subject with known case of systemic disorders.
结局指标
主要结局
There is significant decrease in Pruritus vulvae which will be assessed based on 5-D Pruritus scale
时间窗: Pre assessment 0th day | 1st assessment On 7th day | Follow up On 15th day
次要结局
- Generation of in-depth analysis of duration, degree, direction, disability & distribution of Pruritus vulvae(Generation of data on possible unexpected drug reaction.)
研究者
Dr Gopika P
Sri Sri College of Ayurvedic Science and Research
