跳至主要内容
临床试验/CTRI/2025/02/080422
CTRI/2025/02/080422尚未招募2/3 期

Effect of selected Ayurvedic interventions in Adenomyosis

Meshram Akanksha Yashwant1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年2月20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
26
试验地点
1
主要终点
1.Assessment of dysmenorrhea-will be measured by Visual Analogue scale

研究概览

简要总结

Adenomyosis is a benign uterine disorder characterized by the presence of endometrial glands and stroma in the myometrium. menorrhagia and congestive dysmenorrhea are the typical symptoms of adenomyosis. The enlarged and tender uterus causes dyspareunia or frequent urination. Dyspareunia and chronic pelvic pain are the less common symptoms of adenomyosis that are discussed. Adenomyosis causes a higher incidence of infertility and miscarriage in women. NSAIDs (nonsteroidal anti-inflammatory drugs), GnRH agonists, DANAZOL, and LNG-IUS (levonorgestrel-releasing intrauterine system) loaded intrauterine devices have shown success in reducing the symptoms of menorrhagia and dysmenorrhea associated with adenomyosis. However, these therapies may not be entirely effective for some patients. In situations where medicinal care is insufficient, conservative surgical procedures such as adenomyomectomy, uterine artery embolization, and uterine mass reduction techniques can be used. If all other medical treatment fails,total hysterectomy may be the only option left to improve the patient’s condition. Adenomyosis can be understood as a condition in which there is a vitiated vata and pitta doshas causing Artavaha Dushti in the form of menorrhagia and dysmenorrhea. The involvement of vitiated kapha dosha could be considered in cases of adhesion formation and adenomyoma. So, the ayurvedic interventions includes Guduchyadi Kashaya, mentioned in Ashtanga Hridaya Sutrasthana, Shodhanadi Gana Sangraha Adhyaya indicated for PittaKapha related disorders and Musalikhadiradi Kashaya, as mentioned in the Kashaya Prakaran of Sahasrayogam, indicated for Pradara Rogas along with madhu as anupana Another essential treatment is Madhutailika Vasti, a unique type of Vasti containing Madhu and Taila as main ingredients. This Vasti contains drugs with mridu Veerya, exhibiting broadspectrum efficacy (phalam cha vipulam drishtam) and minimal complications (vyapadam cha api asambhavaha). Madhutailika Vasti combines the lekhana properties of niruha vasti and brimhana properties of sneha vasti, making it a comprehensive treatment option selected for the study. The study design is an interventional pre and post-study, 26 subjects aged 20-50 years, diagnosed with adenomyosis by USG findings, having dysmenorrhea & menorrhagia following the inclusion and exclusion criteria will be taken for the study. Data collection will be done by clinical observation through case proforma and relevant investigations will also be done. Oral administration of 48 ml Guduchyadi Kashaya and Musalikhadiradi Kashaya in combination with 6gm madhu, twice daily 1hour before food for 3 consecutive menstrual cycle and Madhutailika vasti for 3 days in the secretory phase of a menstrual cycle for 3 consecutive cycles. The patient will be assessed at the end of each menstrual cycle. 3 Menorrhagia is assessed by the Pictorial Blood Loss Assessment Chart (PBLAC score) and dysmenorrhea is assessed by the Visual Analogue Scale (VAS). The Adenomyotic changes are assessed by USG (abdomen & pelvis). The data collected will be statistically analyzed through appropriate tests and a conclusion will be drawn.

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
20.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • 1.Women aged 20-50 diagnosed with adenomyosis in USG and willing to give written informed consent 2.patients with dysmenorrhea and/or menorrhagia 3.patient with regular menstrual cycle 4.patients who are fit for madhutailika vasti.

排除标准

  • severe anemia hb less than 7gm percentage pregnant or lactating women patients having any type of malignancies or congenital anomalies of reproductive tract patients with hiv vdrl hbsag positive.

结局指标

主要结局

1.Assessment of dysmenorrhea-will be measured by Visual Analogue scale

时间窗: at the end of each menstrual cycle for 3 consecutive cycle

2.Assessment of menorrhagia- will be measured by Pictorial Blood Loss Assessment Chart.

时间窗: at the end of each menstrual cycle for 3 consecutive cycle

次要结局

  • Assessment of adenomyotic changes - will be done by USG (abdomen & pelvis- Adenomyotic foci either(diffuse or focal, uterine volume in cc, endometrial thickness in mm).)

研究者

发起方
Meshram Akanksha Yashwant
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Meshram Akanksha Yashwant

Government Ayurveda College Tripunithura, Ernakulum, Kerala 682301

研究点 (1)

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