A Prospective Randomized Double blind Comparative Multicentre Phase IV Clinical Trial to evaluate the Efficacy and Safety of SMUTHTM Capsule Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg Docusate Sodium IP 100 mg in comparison with Calcium Dobesilate 500 mg in the treatment of patients with haemorrhoids.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 6
- 主要终点
- To compare the efficacy of SMUTHTM Capsule Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg plus Docusate Sodium IP 100 mg versus Dobesil500mg Capsule Calcium Dobesilate 500 mg in the treatment of patients with haemorrhoids.
研究概览
简要总结
Study Title -A Prospective, Randomized, Double blind, Comparative, Multicentre, Phase IV Clinical Trial to evaluate the Efficacy and Safety of SMUTHTM Capsule (Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg + Docusate Sodium IP 100 mg) in comparison with Calcium Dobesilate 500 mg in the treatment of patients with haemorrhoids.
Investigational Product -
Test Product: SMUTH****TM Capsule(Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg + Docusate Sodium IP 100 mg)
Reference Product: Dobesil 500mg Capsule (Calcium Dobesilate 500 mg).
Treatment Duration - 35 days
Study Endpoints -
Efficacy:
1. Improvement in the following clinical symptoms from baseline to visit 6
Bleeding per rectum
Anal pain
Anal discomfort
Anal pruritus
Tenesmus
Constipation/irregular bowel habits
2. Anoscopy examination assessment (Anitis score) visit 1(Day 0), visit 3(3rdweek), visit 6(6th week).
3. Global assessment of efficacy by the Investigator and Patient.
Safety :
1. 1. Any adverse event reported voluntarily, observed or enquired during the study period based on the evaluation of the following:
Adverse Event (type, number, frequency and proportion of patients)
Concomitant medication.
2. 2. Any clinically significant change in the value of laboratory tests, vital signs and physical examination findings during the study compared to baseline.
3. 3. Global assessment of safety by Investigator and Patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Patients of either gender between 18 and 65 years of age (inclusive of both).
- •Adult patients with 1° or 2° haemorrhoids diagnosed by clinical symptoms and anoscopy examination.
- •Haemorrhoids that bleed but do not prolapse outside the anal canal.
排除标准
- •Patients with 3° or 4° haemorrhoids, in whom the prolapse needed manual reduction or cannot be reduced.
- •Concurrent fistula or chronic anal fissure, inflammatory bowel disease, diabetes, coagulation disorders, abnormal sexual habits.
- •Previous anorectal surgery or previous treatment of haemorrhoid disease with any method other than diet modification and/or topical agents.
- •Clinically significant abnormalities on physical examination or laboratory tests.
- •Pregnant and lactating women.
- •Patients having known hypersensitivity to the study medications and/or ingredients in capsule.
- •Not willing to comply with the protocol requirements.
- •Non-suitability for enrollment otherwise as decided by investigator.
- •Patients having participated in any type of clinical study within the last three months of the screening date.
结局指标
主要结局
To compare the efficacy of SMUTHTM Capsule Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg plus Docusate Sodium IP 100 mg versus Dobesil500mg Capsule Calcium Dobesilate 500 mg in the treatment of patients with haemorrhoids.
时间窗: Visit 1 Day 0 Baseline visit | follow up at Visit 2 Day 7, Visit 3 Day 14, Visit 4 Day 21, Visit 5 Day 28 and Visit 6 Day 35 end of study.
次要结局
- To compare the safety of SMUTHTM Capsule Calcium Dobesilate Monohydrate IP equivalent to Anhydrous Calcium Dobesilate 500mg Plus Docusate Sodium IP 100 mg versus Dobesil500mg Capsule Calcium Dobesilate 500 mg in the treatment of patients with haemorrhoids.(Visit 1 Day 0 Baseline visit)
研究者
Dr Manish Maladkar
Aristo Pharmaceuticals Private Limited