CTRI/2026/02/104540尚未招募2 期
A CLINICAL STUDY ON THE MANAGEMENT OF SALA-E-SADI (FIBROADENOMA OF BREAST) WITH UNANI FORMULATION-AN OPEN LABEL SINGLE ARM TRIAL
Ayurvedic and Unani Tibbia College and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in fibroadenoma size before and after treatment.
研究概览
简要总结
Patients fulfilling the inclusion criteria will be enrolled in the study after obtaining the written informed consent. A detailed History will be evaluated with basic information of each patient, followed by examination, and assessment of objective parameters. Then patient will be given Test drug as mentioned. Patient will be instructed not to take any other medication during trial and report any adverse effects (if any), All findings will be recorded. After completion of trial all data that will be recorded will be statistically analysed.
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
- 15.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women of age group 15-40 years Lumps size of 3 cm or less.
- •Upto BI RADS
- •Married and unmarried both Patient able to participate in the study and ready to follow the instruction and signed the informed consent.
排除标准
- •Patient with h/o severe systemic diseases-DM, HIN, IHD, Renal disease.
- •Women below 15yrs and more than 40yrs of age.
- •BI RADS 0 & BI RADS 3 and above Patient with h/o malignancy.
- •Pregnant and lactating women.
- •Patients on hormonal therapy.
- •Patient not following instruction.
结局指标
主要结局
Change in fibroadenoma size before and after treatment.
时间窗: At baseline & at every 15th day till 90 days
次要结局
- Improvement in symptoms (pain)(At baseline & at every 15th day till 90 days)
研究者
Dr Kausar Jahan
Ayurvedic and Unani Tibbia College and Hospital
研究点 (1)
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