临床试验/CTRI/2023/12/060627

CTRI/2023/12/060627尚未招募3 期

A Randomised single blind,two arms clinical study comparing placebo and unani formulation from authentic pharma copoeia in un complicated Haemorrhoids(Ghair pechide Bawaseer-e-miqad)

Government Nizamia Tibbi College and General Hospital1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2023年12月31日最近更新: 2023年12月20日

试验速览

阶段: 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: Relief in symptoms such as Bleeding per rectum, Prolapse, Mucus dicharge, Pruritis, Pain and discomfort

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

This clinical trial is a Randomised, single blind, two arm study which compares placebo with Unani formulation in the patients with Haemorrhoids. The total number of patients will be divided into group A and group B and alloted the placebo along with lifestyle management and unani formulation respectively for 35 days. The primary outcomes will be assessed weekly once for 35 days.

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: 18.00 Year(s) 至 65.00 Year(s)（—）
性别: All

入选标准

•Age between 18-65 years Both sexes Patient with symptom prolong constipation Patient with diagnosis of acute uncomplicated first and second degree Haemorrhoids Rectal bleeding Pain on defecation Prolapse Mucus discharge Pruiritis.

排除标准

•Pregnant and lactating women Uncontrolled diabetes and hypertension Complicated case of haemorrhoids like thrombosis, strangulation, gangrene and carcinoma of rectum Fistula and fissure in ano Liver disorder Severe anemia.

结局指标

主要结局

Relief in symptoms such as Bleeding per rectum, Prolapse, Mucus dicharge, Pruritis, Pain and discomfort

时间窗: Relief in symptoms such as Bleeding per rectum, Prolapse, Mucus dicharge, Pruritis, Pain and discomfort every 7 days for 5 weeks

次要结局

Relief in associated symptoms such as indigestion and constipation(Before and after treatment of 35 days)

研究者

发起方

Government Nizamia Tibbi College and General Hospital

申办方类型

Research institution and hospital

责任方

Principal Investigator

主要研究者

Dr Dudekula Faheemunnisa

Govt.Nizamia Tibbi College and General Hospital,Charminar,Hyderabad.

研究点 (1)

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