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临床试验/CTRI/2024/06/069474
CTRI/2024/06/069474尚未招募2/3 期

A Randomized Open Labelled Comparative Clinical Study to Evaluate the Efficacy Of Shothahara Mahakashaya Ghanvati and Palashadi Yog Basti in the management of Beej kosha Granthi w.s.r Ovarian Cyst

Priyanka1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7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
40
试验地点
1
主要终点
TO RESOLVE OR REDUCE THE SIZE OF OVARIAN CYST

研究概览

简要总结

Ovarian Cyst is the most common Emerging disease occurring in the women of Reproductive Age Group Ovarian Cyst is a knotty raised elevation which is nodular or glandular rough swelling, can be neoplastic or non-neoplastic When the follicles (Sacs) in the ovaries do not rupture they form small cysts and called “Simple Cyst Ovarian Cyst is the most common benign neoplasm, found in approximately 20 to 40% women of reproductive age group Though many women are not aware of them but majority women with cyst are asymptomatic but in some women it shows Many symptoms like- Dysmenorrhea, Irregular Menstruation, Lower abdominal Pain, Breast Tenderness, Lower Backache

In ayurveda Classics, Special reference of granthi of female reproductive system is not available, but

i)                   Granthi described in samhitas can be considered and treated according to their doshas involvement

ii)                 On the basis of its origin beejkosha (Ovary) and its surrounding, it can be compared with beejkosha granthi

When Rakta, Mamsa & meda are vitiated by Tridoshas that are admixed with Kaphaproduce round, glandular , protuberant, knotty and firm swelling called granthi  Such Clinical entity can be Ovarian Cyst where vatadosha is the predominant pathological factor being the natural site of its location (Basti Pradesh) in the body The principle of Samprapti Vighatan i.e., to break the pathogenesis is used for the management of ovarian cyst

The Protocol for the treatment of ovarian cyst is to dissolve/reduce the size of cyst. Hence, an attempt on Shothahara Mahakashaya described by Acharya Charaka we convert in ghanvati Formation for Trialand Palashadi yog basti mentioned in Charaka Samhita

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
18.00 Year(s) 至 55.00 Year(s)(—)
性别
Female

入选标准

  • Patients having cysts size less than or equal to 8 cm as per USG report (persist at least for 2 consecutive cycles) Single or multiple cysts/ unilateral or bilateral/ unilocular/ multilocular ovarian cysts Patients either asymptomatic or having clinical sign and symptoms of ovarian cysts Women with Hb more than 8gm/dl Patient willing to participate in trial.

排除标准

  • Patients having cyst size more than 8 cm as per USG report Women with HB less than 8gm/dl Tubo-ovarian mass Dermoid cyst Para-ovarian cyst Endometriotic cyst Haemorrhagic Cyst Malignant tumours and Fibroid Patient with uncontrolled HTN TB DM and any other systemic diseases Patients with CA-125 more than 50 units/ml.

结局指标

主要结局

TO RESOLVE OR REDUCE THE SIZE OF OVARIAN CYST

时间窗: TO RESOLVE OR REDUCE THE SIZE OF OVARIAN CYST | TO IMPROVE THE SIGN AND SYMPTOMS ASSOCIATED WITH OVARIAN CYST

TO IMPROVE THE SIGN AND SYMPTOMS ASSOCIATED WITH OVARIAN CYST

时间窗: TO RESOLVE OR REDUCE THE SIZE OF OVARIAN CYST | TO IMPROVE THE SIGN AND SYMPTOMS ASSOCIATED WITH OVARIAN CYST

次要结局

  • CHANGES IN OTHER ASSOCIATED CLINICAL FEATURES RELATED TO OVARIAN CYST(FOLLOW UP FOR SUBJECTIVE SYMPTOMS AFTER EVERY 1 MONTH AND FOR OBJECTIVE SYMPTOMS AFTER 3 MONTH)

研究者

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

Priyanka

Institute For Ayurved Studies and Research Umri Road Sector 8 Kurukshetra

研究点 (1)

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