A Phase III, Multicenter, Randomized, Open-label, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Trĩ Thiên Dược Capsules in Grade II Internal Haemorrhoids Patients With Bleeding Compared to Diosmin.
概览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Hanoi Medical University
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Mean duration of rectal bleeding
概览
简要总结
A Phase III, randomized, double-blind, placebo-controlled clinical trial has been conducted to evaluate the efficacy and safety of Trĩ Thiên Dược capsules in people with grade II internal hemorrhoids with bleeding. This study aims to further assess the therapeutic effects and potential adverse effects of Trĩ Thiên Dược, a herbal formulation containing Portulaca Oleracea L. (purslane) and Amaranthus Spinosus L. (spiny amaranth), in comparison to Diosmin (Daflon).Participants will undergo a 5-week study period and will be randomly assigned (1:1 ratio) into one of two groups:Research Group: Participants receiving Trĩ Thiên Dược tablets.Control Group: Participants receiving Daflon (Diosmin).The treatment regimen will last for 28 days, followed by an additional follow-up period extending to day 35 after the initial treatment.
详细描述
Study Design:
This study is a randomized, open-label, placebo-controlled trial evaluating the efficacy of Diosmin (Daflon) in people with grade II internal hemorrhoids with bleeding. Participants are randomly assigned in a 1:1 ratio to receive either Tri Thien Duoc pills or Diosmin (Daflon).
Participants:
A total of 172 participants with grade II internal hemorrhoids with bleeding were enrolled in the study and allocated as follows:
Intervention Group: 86 participants received Tri Thien Duoc pills at a dosage of 8 capsules per day for 28 days, with follow-up conducted for 35 days from the initiation of treatment.
Control Group: 86 participants received Diosmin (Daflon) at a dosage of 4 pills per day for 28 days, with follow-up conducted for 35 days from the initiation of treatment.
Study Procedures:
All participants in this Phase III study adhered to the dietary and lifestyle recommendations outlined by the American Gastroenterological Association for hemorrhoid management, including:
Maintaining a high-fiber diet rich in vegetables and soft foods. Ensuring adequate hydration (1.5-2 litres of water per day). Engaging in regular physical activity. Avoiding prolonged sitting.
Assessments and Monitoring:
Participants underwent clinical evaluations and monitoring throughout the study. Key clinical parameters were assessed at four-time points:
Baseline (Day 0, D0) Mid-treatment (Day 14, D14) End of treatment (Day 28, D28) Post-treatment follow-up (Day 35, D35) Laboratory tests, including liver and kidney function assessments, complete blood count, urinalysis, and colonoscopy, were conducted at baseline (D0) and treatment's end (D28).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •\- Inclusion Criteria
- •Patients must meet all of the following criteria to be eligible for the study:
- •Age 18 to 65 years
- •Diagnosis of grade II internal hemorrhoids with bleeding, presenting with the following symptoms:
- •Hemorrhoids prolapse with gentle straining and retract spontaneously Presence of blood in stool Congested and/or bleeding hemorrhoids
- •Having symptoms such as anal pain and anal itching
- •Willingness to voluntarily participate in the study -
排除标准
- •Patients meeting any of the following criteria will be excluded from the study:
- •History of malignancy, including colon cancer and other cancers
- •Anal polyps and proctitis
- •Anal fissures with bleeding
- •Systemic diseases, such as hypertension, liver failure, kidney failure, heart failure, and coagulation disorders.
- •Other severe acute or chronic illnesses
- •Mixed hemorrhoids or conditions requiring immediate surgical intervention, such as hematoma, severe bleeding, or hemorrhoidal infarction
- •Recent use of other hemorrhoid medications (within 7 days prior to study enrollment)
- •Known allergy to any component of the study medications
- •Pregnant or lactating women
研究组 & 干预措施
Diosmin
Control group: 86 participants with stage II hemorrhoids with bleeding
干预措施: Control group (diosmin) (Drug)
Tri Thien Duoc capsules
Intervention Group: 86 participants with stage II hemorrhoids with bleeding
干预措施: Intervention Group: Tri Thien Duoc Capsules (Drug)
结局指标
主要结局
Mean duration of rectal bleeding
时间窗: Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)
Mean duration of fresh rectal bleeding episodes: Defined as the mean number of days the patient experiences fresh rectal bleeding.
Rate of cessation of rectal bleeding
时间窗: Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)
Defined as the proportion of patients who achieve complete cessation of fresh rectal bleeding out of the total number of patients
Severity of hemorrhoidal symptoms
时间窗: Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment)
the mean symptom score of participants according to the Sodergren scale.
次要结局
- Pain score during defecation(Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment))
- Rate of recurrent bleeding(During 35 days of follow up)
- Degree of defecation disorder(Baseline (Day 0, start of treatment) End of treatment (Day 28, after 28 days of treatment) Follow-up (Day 35, 7 days post-treatment))
- Degree of hemorrhoid prolapse(Baseline (Day 0, start of treatment); End of treatment (Day 28, after 28 days of treatment))
- Anal mucosal condition(Baseline (Day 0, start of treatment); End of treatment (Day 28, after 28 days of treatment))
- Adverse Events(During 28 days of treatment)