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临床试验/CTRI/2025/05/087643
CTRI/2025/05/087643尚未招募2 期

Randomised Comparative Clinical Study to Evaluate the Efficacy of Gomutra Haritki Churna and Kanchnar Churna along with Mulakadi Taila Uttara Basti on Garbhashaya Arbuda W.S.R to Uterine Fibroid

Madan Mohan Malviya Govt. Ayurved College Udaipur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月28日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the effect of trial drug and procedure to Change in the size and volume of uterine fibroid

研究概览

简要总结

The most common benign tumour of the uterus is the uterine fibroid. Despite not being malignant, it can have a negative impact on women’s overall health and quality of life. Among women over 30 years the disease has a 20% prevalence These are more prevalent in nulliparous couples or infertile individuals with one kid. Gynaecologist often deal with uterine fibroids in their daily practice. Oral medication, hormonal therapy, hysterectomy, and other therapeutic techniques are used to treat uterine fibroids, but they are less effective, and patients find it difficult to accept hysterectomy .Due to Modern science limitation,  Ayurveda has great scope in the field to find out effective and invasive approach to manage the disease and improve the quality of life This Study is about to Randomized Comparative Clinical Study to Evaluate the Efficacy of Gomutra Haritaki Churna and Kanchanar Churna along with Mulakadi taila Uttara basti on Garbhashaya Arbuda W.S.R. to Uterine Fibroid There will be Two Group of 30 Patient. Group A Patient will be treated with Gomutra Haritaki Churna 3 gm BD and 5 ml mulkadi  Taila Uttarbasti  Basti (per vaginal) for 3 days for 3 consecutive menstrual cycle. while other 30 patients of group B will be treated with 3 gm BD kanchanar churna and 5 ml mulkadi Taila uttara Basti (per vaginal for 3 days for 3 consecutive menstrual cycle.  This trial study will be carried out for 3 months (90 days) & the follow up of the case will be after every 15 days. Final assessment will be done after completion of 3 months of treatment course on the basis of subjective, objective assessment and laboratory investigations.The data

will be analyzed scientifically and statistically.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
30.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • 1.Patient who are willing for trial 2.Single or multiple uterine fibroid 3.The patient either asymptomatic or having clinical sign and symptoms of fibroid.

排除标准

  • 1.Patient having bleeding due to abortion or any other pathological condition 2.Patients having coagulation disorders.
  • 3.Patient of age less than 30 years and above 50 years 4.Pregnant women 5.Anemic patient whose hemoglobin is below 7 gm.% 6.Patient having any systemic disease like uncontrolled hypertension, diabetes mellitus 7.Patient using IUCDs 8.Having any kind of malignancy.
  • 9.Patient with positive VDRL, HIV, HbsAg, 10.Patients who are contraindicated for Uttar Basti.
  • 11.Large size uterine fibroid with severe menorrhagia and severe pressure symptoms.

结局指标

主要结局

To compare the effect of trial drug and procedure to Change in the size and volume of uterine fibroid

时间窗: 90 days

次要结局

  • To compare the effect of trial drug and procedure on clinical features of the Garbhashaya Arbuda(90 days)

研究者

发起方
Madan Mohan Malviya Govt. Ayurved College Udaipur
申办方类型
Government medical college

研究点 (1)

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