跳至主要内容
临床试验/CTRI/2024/11/077505
CTRI/2024/11/077505尚未招募2/3 期

A RANDOMIZED OPEN LABELLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF KSHARA GUDIKA AND PANCHATIKTA GHRITA UTTARBASTI IN THE MANAGEMENT OF GARBHASYA ARBUDA W.S.R UTERINE FIBROID

INSTITUTE FOR AYURVED STUDIES AND RESEARCH1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月4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
60
试验地点
1
主要终点
To resolve or reduce the size of Uterine Fibroid.

研究概览

简要总结

Women’s health should be a big focus in any female’s life. Fibroid is defined as non-cancerous growth in the uterus that can be developed during a woman’s childbearing years. Estimated incidence of uterine fibroid found approx. 20-40% women of reproductive age. Asymptomatic fibroid may present in 40-50% of women older than 40 yrs. of age. In today’s scenario, uterine fibroids are major health concern for women.  Fibroids dependent on estrogen & progesterone to grow, therefore relevant only during reproductive years, then they are expected to shrink after menopause. Regarding its treatment, surgical intervention has historically been mainstay of uterine fibroid treatment, Women looking for non-invasive methods. Due to modern science limitation, Ayurveda has great scope in the field to find out effective & non-invasive approach to manage the disease and improve the quality of life. On Exploring Samhita, study revealed that symptomatology of disease entity "Arbuda" correlated to Tumor. In classical texts, special reference of Arbuda of female reproductive system not available, but on basis of the origin in Garbhasya (uterus), it is compared with Garbhasya Arbuda. Aggravated Doshas, vitiating Mamsa, Rakta, Meda getting localized in garbhasya (uterus) produces local swelling in deep muscles which is round, fixed, small, big associated with pain, deep seated roots, increasing gradually. The principle of Samprapti Vighatan i.e. to break the pathogenesis used for the management of uterine fibroid. The protocol for the treatment of Garbhasya Arbuda is to dissolve/ to reduce the size. Here an attempt on Kshara Gudika described by Acharya Charaka via oral route and Panchatikta Ghrita mentioned in Yog Ratnakar via Uttar Basti.

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

入选标准

  • Patient having uterine fibroid size less than or equal to 5cm as per USG report, Single/Multiple fibroids.
  • Patient either asymptomatic or having clinical signs and symptoms of uterine fibroid.
  • Patient willing to participate in trial.

排除标准

  • Patient below age 20 years & above age 50 years.
  • Patient having fibroid size more than 5cm as per USG report.
  • Pregnancy, Unmarried, Post-Menopausal, Ovarian tumor, Tubo-ovarian mass, any Malignant tumor, sarcomatous changes in fibroid, fibroid with adenomyosis.
  • Patient with BMI less than 18.5/ Hyperacidity/ Ulcers (for oral drug).
  • Patient with HTN, TB, Uncontrolled DM and any other severe systemic diseases.

结局指标

主要结局

To resolve or reduce the size of Uterine Fibroid.

时间窗: To resolve or reduce the size of Uterine Fibroid reviewed on 30,60,90 days | To improve the signs and symptoms associated with uterine fibroid reviewed on 30,60,90 days

To improve the signs and symptoms associated with uterine fibroid.

时间窗: To resolve or reduce the size of Uterine Fibroid reviewed on 30,60,90 days | To improve the signs and symptoms associated with uterine fibroid reviewed on 30,60,90 days

次要结局

  • Changes in other associated clinical features related to uterine fibroid.(Follow up for subjective criteria after every 1 month.)

研究者

发起方
INSTITUTE FOR AYURVED STUDIES AND RESEARCH
申办方类型
Other [GOVERNMENT AYURVEDIC COLLEGE]
责任方
Principal Investigator
主要研究者

DR PINKI

INSTITUTE FOR AYURVED STUDIES AND RESEARCH

研究点 (1)

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