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临床试验/CTRI/2024/12/077827
CTRI/2024/12/077827尚未招募2/3 期

Effect of Pathyaputhikadi kashaya and Kankayana gudika in Uterine fibroid

Karthika Dev S1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2024年12月18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
To assess the effect of Pathyaputhikadi kashaya and Kankayana gudika in pain and bleeding during menstruation associated with Uterine fibroid

研究概览

简要总结

Uterine fibroids also known as Leiomyomas, are smooth tumors of the These are more common in nulliparous or in those having one child infertility. Symptoms include abnormal uterine bleeding, dysmenorrhoea, pelvic pressure, bowel dysfunction , urinary frequency and urgency, urinary retention, low back pain, constipation and dyspareunia.

There is no direct reference for uterine fibroid in Ayurveda. The treatments explained in the context of Gulma and Sula can be taken for the management of uterine fibroid. Pathyaputhikadi kashaya is mentioned in Sahasrayogam with an indication of Arsa, Gulma, Ashteela, Anaha , Sula etc and Kankayana gudika is mentioned in Bhaishajya Ratnavali with an indication of Gulma,Arsa etc are taken for the study.

The study design is an interventional pre and post study, with a sample size of 26. Subjects aged 18 -45 years, diagnosed with Uterine fibroid having pain and bleeding 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. The medicine will be administered on the following basis. 48 ml of Pathyaputhikadi kashaya before food during intermenstrual phase and 2 tablets (600 mg) of Kankayana gudika with 50 ml milk after food during the bleeding phase, twice daily for 3 consecutive menstrual cycle. The patient will be assessed at the end of each menstrual cycle. Menstrual bleeding is assessed by the Pictorial Blood Loss Assesment Chart (PBAC scale) and pain during menstruation, low back ache, pelvic pressure is assessed by Visual Analogue scale ( VAS). The size of the fibroid is assessed by USG before treatment and after treatment. The data collected will be statistically analysed 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
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Participants of age group 18-45 years with Uterine fibroids, confirmed by USG having complaints of pain and bleeding during menstruation.

排除标准

  • Pregnant and lactating women Post menopausal women Hb less than 8 gm% Fibroid size greater than 8 cm Degenerative changes in the uterine fibroid confirmed by USG Known cases of malignancy and genital Tb Known case of uncontrolled Hypertension, Diabetes mellitus Known cases of chronic liver and renal disease and coagulation disorders.

结局指标

主要结局

To assess the effect of Pathyaputhikadi kashaya and Kankayana gudika in pain and bleeding during menstruation associated with Uterine fibroid

时间窗: After 4 th week,8th week and 12th week

次要结局

  • To assess the effect of Pathyaputhikadi kashaya and Kankayana gudika in pelvic pain and low back ache associated with Uterine fibroid(To assess the effect of Pathyaputhikadi kashaya and Kankayana gudika in reducing the size of the fibroid)

研究者

发起方
Karthika Dev S
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Karthika Dev S

Government Ayurveda Medical College

研究点 (1)

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