临床试验/CTRI/2024/08/072215

CTRI/2024/08/072215尚未招募2/3 期

A prospective clinical study to determine the therapeutic dose of Centchroman in the manangement of cyclical mastalgia

Uttar Pradesh University of Medical Sciences1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2024年8月19日最近更新: 2024年8月8日

试验速览

阶段: 2/3 期
状态: 尚未招募
发起方: Uttar Pradesh University of Medical Sciences
入组人数: 100
试验地点: 1
主要终点: Symptomatic relief from cyclical mastalgia.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Trial is still running and we have still not completed total no of participants

研究设计

研究类型: Interventional
分配方式: Coin toss, Lottery, toss of dice, shuffling cards etc
盲法: Participant Blinded

入排标准

年龄范围: 15.00 Year(s) 至 40.00 Year(s)（—）
性别: Female

入选标准

•All women with mastalgia with VAS score â‰¥3 lasting for more than 5-7 days per cycle were included after signing a consent form.

排除标准

•â€¢ Patients with polycystic ovarian diseases and uterine cervical hyperplasia.
•â€¢ First six months of Lactation and pregnancy â€¢ Patients who were not giving consent.
•â€¢ Past history of breast carcinoma or family history of breast carcinoma â€¢ Patient who were planning for pregnancy .
•â€¢ Women suspected or diagnosed of malignancy â€¢ Recent history of jaundice or hepatic impairment.
•â€¢ Severe allergic states.
•â€¢ History of thrombosis.

结局指标

主要结局

Symptomatic relief from cyclical mastalgia.

时间窗: Outcome will be assessed at 4,8,12 and 24 weeks

次要结局

Improvement in fibroadenosis as well as reduction in size of fibroadenoma.(Outcome will be assessed at 4,8,12 & 24 weeks)

研究者

发起方

Uttar Pradesh University of Medical Sciences

申办方类型

Government medical college

责任方

Principal Investigator

主要研究者

Dharmendra Tarkar

UPUMS SAIFAI ETAWAH

研究点 (1)

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