跳至主要内容
临床试验/CTRI/2025/11/097657
CTRI/2025/11/097657尚未招募2 期

EFFICACY OF XX VAGINAL SPRAY AND XX VAGINAL SUPPOSITORY IN THE MANAGEMENT OF ACHARNA YONI VYAPAT W S R TO VAGINAL MICROBIOTA DYSBIOSIS MULTI ARM RANDOMISED CONTROL CLINICAL TRIAL

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年12月2日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Primary outcome: Change in VMES (Reduction in Excessive Vaginal Discharge Vaginal

研究概览

简要总结

Need of Study  In day to day practice the complaint of vaginal discharge is very common A change in the life style due to rapid urbanization  poor awareness emotional causes such as stress anxiety etc faulty dietary habits such as excessive use of tea coffee alcohol smoking etc higher antibiotics use birth control pills excessive work load unhygienic condition and individual habits like shame hesitation to submit to doctor etc  all contribute towards high incidences It is generally known that vaginal microbiota disturbance is highly related to various gynecological diseases especially Bacterial vaginosis  which is characterized by the alteration of vaginal microbiome from Lactobacillus dominance to anaerobic Bacterial vaginosis has been shown to be associated with various other reproductive tract disorders including infertility preterm cervical cancer and HIV acquisition (Leitich and Kiss 2007  van Oostrum et al  2013 Torcia, 2019) It is also reported that many sextually transmitted infections (STI) such as infections of N gonorrhoeae and C trachomatis are facilitated by vaginal microbiota dysbiosis It may also convert in chronicity which produces secondary complications Taking into account the complications of untreated vaginal discharges it therefore imperative that this condition be actively treated and quality of life restored

Rational for Selection of intervention/justification for Selection of trial drugs    Panchavalkala is one of the compound regimen popularly used and prescribed in the 6 classics for various gynecological disorders specially leucorrhoea uterine diseases and cervical erosions and also for wounds and ulcers in other parts of body The combination of the barks of 5 medicinal plants namely Vata (Ficus bengalensis) Udumbara (Ficus glomerata) Ashwatha ( Ficus religiosa ) Plaksha ( Ficus infectoria) Parisha ( Thespia populnea) in equal proporations is known as the Classical Panchavalkala Panchvalkala is having properties like Kashaya Rasa Sheetavirya Katuvipaka Panchvalkala have the best antibacterial and antifungal activity

Triphala is mild non habit forming and rejuvenative and hence recommenced for all It exhibits antiviral antibacterial antifungal antiallergic propertiesTriphala and its constituents act as improve blood circulation It shows immunomodulatory properties and helps in improving the body defence mechanism I have kashaya Rasa madhurvipaka Tridoshar Azadirachta indica is known to possess anti inflammatory antipyretic antimicrobial ant diabetic and diverse pharmacological properties It have Tikata kashaya Rasa laghu Guna Sheetavirya katuvipaka kandhughana prabhav  pitta kaphahar Dosha karma  Anti inflammatory and anti microbial activities of the root bark and leaves of A Indica Neem (Azadirachta indica) seed and leaf extracts have spermicidal anti microbial antifungal and antiviral properties They are also immuno modulatory that induce primarily a TH1 type response Honey has anti bacterial property Honey has well established function as an effective antibacterial agent with a broad spectrum of activity against Gram positive and Gram negative bacteria Some studies suggest that the topical use of honey may reduce odors swelling and scarring when used to treat wounds It have Madhura Rasa kasha anurasa ruksha Guna tridosha shamaka Sphatika has styptic and astringent properties It also acts as adjuvant It have kashaya kattu amala Rasa ushanavirya kandu tridoshanashak yonisankochak raktastravarodhaka

Haridra acts as an anti inflammatory antidiabetic anti diarrhoeal Hypolipidemic Hepatoprotective Anti cancerous It have Tikt Katu Rsa Ruksh  Laghu Guna Ushnavirya Katuvipak Kusthaghan Prabhav Kpha vat shamak dosha karma Vidanga is a useful herb to manage worm infestation that includes threadworms roundworms and types of worms due to its karimighna property It have Katu Kashya Rasa Laghu Ruksha Tikshna Guna Ushna virya Katu Vipaka Krimighna Prabhav Kapha Vatshamak dosha karma So In the present trial an attempt has been made to establish the efficacy of XX vaginal spray and XX Vaginal suppository in the management of acharna yoni vyapat w s r to vaginal microbiota dysbiosis

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Married Women with age group between 21 to 40 years diagnosed with Acharna yoni vyapat such as kandu and excessive vaginal discharge Patients with abnormal Vaginal Microecology Evaluation System VMES.

排除标准

  • Unmarried women Pregnant women Patients suffering from Sexually Transmitted Diseases which is evident from positive HIV VDRL HbsAg Anti HCV Patient using oral contraceptive pills and IUCDs Previous history of any major systemic illness such as Tubercular infections and uncontrolled diabetes mellitus CIN II CIN III Cervical carcinoma Associated with any gynaecological complications such as cervical fibroid large ovarian cyst and genital prolapse genital TB Patient has received antifungal or antimicrobial therapy systemic or intra vaginal in last one month.

结局指标

主要结局

Primary outcome: Change in VMES (Reduction in Excessive Vaginal Discharge Vaginal

时间窗: 30 days

Itiching and Burning Sensation)

时间窗: 30 days

次要结局

  • Quaility of Life(30 days)

研究者

申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr ANITA KUMARI UJJWAL

National Institute of Ayurveda

研究点 (1)

Loading locations...

相似试验

A CLINICAL TRIAL TO STUDY THE EFFICACY OF AYURVEDA... | 临床试验