A Single Center Single Arm Pilot Study Assessing Efficacy and Safety of Herbal Powder in Patients with Symptomatic Hemorrhoids
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rectal symptoms
研究概览
简要总结
Hemorrhoids may develop for a number of reasons, such as constipation, obesity, a diet low in fiber, prolonged sitting or standing, deteriorating muscle tone with age, colon cancer, or consequences from surgery or trauma.
Bleeding from the lower gastrointestinal segments is most likely to be the main prevalent etiological reason of the incidence of hemorrhoids. Anal pain and discomfort, itching, bleeding, swelling, and perceived mass in the
perianal zone are considered as the main symptoms of hemorrhoids.
If left untreated, hemorrhoids can worsen and become complicated over time. Conservative methods of treatment for haemorrhoids are covered, including oral rehydration, non steroidal anti-inflammatory medications, rest, and dietary fibre, as well as surgical treatments with varying degrees of complications. Surgical hemorrhoidectomy should be reserved for patients with grade IV hemorrhoids and some patients with grade III hemorrhoids who have not responded to office procedures or cannot tolerate them. There are many complications following office-based procedures and operations such as stenosis, infection, fibrosis, fecal incontinence, urinary retention, and ectropion.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male/ female participants ≥ 18 years of age at the time of consent.
- •Participants with symptomatic internal hemorrhoids, Grades I-III by direct anoscopic visualization (anoscopic visualization not required if Grade determined by colonoscopy within 28 days prior to screening).
- •Participants who can attempt bowel movements daily.
- •Female participant of non-childbearing potential, including any female who: a) has had a hysterectomy, b) has had a bilateral oophorectomy, c) has had a bilateral tubal ligation or d) is post-menopausal (demonstration of total cessation of menses for ≥ 1 year from the date of the screening visit)
- •Female participants of childbearing potential who agree to use two forms of contraception, one of which must be a barrier method, during the full duration of the study.
- •Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures.
排除标准
- •1 Participants with Grade 4/prolapsed hemorrhoids 2 Participants having taken any herbal medications in the last 30 days 3 Participants who are planning to undergo any surgical procedure for hemorrhoids 4 Participants with major hepatic, renal, or cardiovascular ailments 5 Participants with a history of inflammatory bowel disease 6 Participants with a history of irritable bowel syndrome with constipation or diarrhea 7 Participants with clinical evidence or history of anal fissure 8 Participants with hemoglobin Greater than10.0 g/dL 9 Participants using anal, intra-anal, or intra-rectal steroids within 28 days prior to screening day 10 Pregnant and female lactating women at the time of screening 11 Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
结局指标
主要结局
Rectal symptoms
时间窗: Day 0, Day 15, Day 30.
To evaluate and compare number
时间窗: Day 0, Day 15, Day 30.
of patients achieving composite
时间窗: Day 0, Day 15, Day 30.
score ‘0’ at the end of study (Day
时间窗: Day 0, Day 15, Day 30.
30).
时间窗: Day 0, Day 15, Day 30.
Following symptoms will be
时间窗: Day 0, Day 15, Day 30.
considered for the assessment:
时间窗: Day 0, Day 15, Day 30.
- Tenesmus
时间窗: Day 0, Day 15, Day 30.
- Mucous in stools
时间窗: Day 0, Day 15, Day 30.
- Stool consistency
时间窗: Day 0, Day 15, Day 30.
- Stool frequency
时间窗: Day 0, Day 15, Day 30.
- bleeding per rectum
时间窗: Day 0, Day 15, Day 30.
- pruritus
时间窗: Day 0, Day 15, Day 30.
Hemorrhoidal symptoms
时间窗: Day 0, Day 15, Day 30.
- sphincter spasm
时间窗: Day 0, Day 15, Day 30.
- degree of hemorrhoids
时间窗: Day 0, Day 15, Day 30.
- ease of reduction.
时间窗: Day 0, Day 15, Day 30.
次要结局
- Number of Treatment Emergent Adverse Event((TEAE) and Treatment Emergent Serious Adverse)
研究者
Dr S Chikkalingaiah
General Physician