CTRI/2024/05/068120尚未招募2 期
An open-label randomized controlled clinical study to compare the efficacy and safety of Saboos Isapgol with Syrup Cremaffin in patients with uncomplicated Da’imi-Qabz (Chronic Constipation)
Government Tibbi College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Stool frequency
研究概览
简要总结
Patients with uncomplicated chronic constipation are enrolled according to inclusion and exclusion criteria, and diagnosis is made by history taking, clinical examination and lab investigation , then, after I give it to a Unani drug named Saboos Isapgol to evaluate the efficacy and safety of the drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having the complaints of: 1.Abdominal pain or discomfort 2.Reduced bowel movements (less than 3/week) or infrequent stools 3.Sense of incomplete evacuation 4.Nausea or flatulence 5.Pain at defecation 6.Straining at defecation 7.Patient willing to sign the written informed consent to participate in this trial.
排除标准
- •1.Below 20 years and above 60 years of patient.
- •2.Pregnant and lactating women.
- •3.Patients taking other drugs such as atropine and opium group.
- •4.Patients taking any antacid medicine which has aluminium and calcium.
- •5.Associated Complications like Diabetes mellitus, Hypertension, Hyperthyroidism, anal fistula, anal fissure, haemorrhoids, hernia, ano-rectal abscess, etc.
- •6.Mentally retarded person and prisoners.
- •7.Patients with chronic debilitating diseases, or neurologic abnormalities.
- •8.Non ambulatory / Bed ridden patients.
- •9.One who had previous surgery of the colon.
- •10.Patient having diagnosed intestinal structural abnormality.
- •11.Patient with phlegmatic temperament.
- •12.Patient who’s not agree to give consent.
结局指标
主要结局
Stool frequency
时间窗: baseline, | 1st Follow up at the end of second week
(Number of stools per week)
时间窗: baseline, | 1st Follow up at the end of second week
Stool consistency
时间窗: baseline, | 1st Follow up at the end of second week
(1- hard; 2- firm; 3- loose)
时间窗: baseline, | 1st Follow up at the end of second week
次要结局
- Assessment according to ROME Diagnostic Criteria(2nd Follow up at the end of fourth weeks)
研究者
Saleha Aftab
Government Tibbi College and Hospital
研究点 (1)
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