Male and female subjects, at least 18 years of age with a diagnosis of internal haemorrhoids (1° and 2°) confirmed by protoscopic examination and suffering form an uncomplicated and untreated acute attack. MedDRA version: 9.1 Level: LLT Classification code 10022577 Term: Internal haemorrhoids
Conditions
Interventions
Product Name: Euphorbia prostrata Dry Extract 100 mg tablet
Pharmaceutical Form: Film-coated tablet
Other descriptive name: Euphorbia Prostrata dry extract ethanolic 80% (v/v) [(35-70):1]
Pharmaceutic
Sponsors
Panacea Biotec Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult subjects able to understand nature, significance and scope of the clinical trial agreeing to participate in the study by giving written informed consent. • Male or female subjects, at least 18 years of age with a diagnosis of internal haemorrhoids (1° and 2°) confirmed by proctoscopic examination and suffering from an uncomplicated and untreated acute attack (defined as acute onset of per rectal bleeding within 3 days of inclusion into the study, with at least one of the symptoms viz. pain, tenesmus, pruritus and anal discharge). • Except internal haemorrhoids (1° and 2°), the subject is judged to be in general reasonable health, based on medical history, physical examination, and laboratory screening tests, enabling him or her to complete the trial without anticipated serious co-morbid event. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant of lactating women. Women in post-partum period of up to 6 weeks will be excluded. • Women of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception (resulting in a failure rate less than 1% per year) during the study therapy and for 4 weeks after the end of study therapy. • Subjects who have been previously enrolled in a study involving E. prostrata Dry Extract. • Subjects with previous history of surgery for anorectal disease (within 5 years) or any other procedures (including but not limited to injection sclerotherapy, rubber band ligation, photo coagulation, cryotherapy etc.) within 2 years. • Subjects who in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained. • Subjects with clinically significant co-morbid condition that in the opinion of the investigator could affect the efficacy and safety outcome of the study. • Subjects with laboratory values falling outside the defined reference values for haemoglobin, total leucocyte count, differential count, bleeding time, clotting time, PT/INR, aPTT/control, platelet count, SGOT, SGPT, alk. phosphatase, total bilirubin, random blood sugar, serum cholesterol, blood urea, serum creatinine and urine routine and microscopic examination. • Treatment with any of the following at inclusion or in the previous one month-venotropic, anticoagulant, and anti-platelet agent. Subjects on aspirin up to 160 mg for cardiovascular indication will not be excluded from the trial. • Treatment with any of the following at inclusion or in the previous one week anti-inflammatory and analgesic agent. • Other chronic medications not being used at a stable dosage for at least 2 weeks. • Subjects who are currently users (including "recreational use") of illicit drugs or with a history of drug abuse within the past 5 years. • Subjects who have donated a unit of blood or plasma or participated in another clinical study with an investigational agent within the last 4 weeks. • Subjects with associated anal fissures, and/or infective anal pathology.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy of E. prostrata Dry Extract tablets compared to placebo in the treatment of internal haemorrhoids (1° and 2°), based on the proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject (cessation of per rectal bleeding defined as the maintenance of bleeding cessation for at least three continuous days after initial "cessation of bleeding");Secondary Objective: The secondary objectives are to evaluate the efficacy of E. prostrata Dry Extract tablets compared to placebo - in the treatment of internal haemorrhoids (1° and 2°), based on the proportion of sujects in each treatment group without recurrence of bleeding (recurrence of bleeding defined as any episode of bleeding after maintenance of bleeding cessation and before the end of 14 days post-treatment). - based on the change in following symptoms as assessed by subject viz. pain, tenesmus, pruritus, anal discharge and following signs as assessed by the investigator viz. congestion, oedema and exudation. - based on the difference between the two treatment groups in overall assessment of disease condition as assessed by the subject. - by comparing the incidences of clinical and laboratory adverse experiences between the two treatment groups.;Primary end point(s): Primary Enpoints: • Proportion of subjects in each treatment group achieving cessation of per rectal bleeding as assessed by the subject at day 14 (cessation of per rectal bleeding defined as the maintenance of bleeding cessation for at least three continuous days after initial "cessation of bleeding) Secondary Endpoints: • Proportion of subjects in each treatment group without recurrence of bleeding (recurrence of bleeding defined as any episode of bleeding after maintenance of bleeding cessation and before the end of 14 days post-treatment). • Change in the following symptoms viz., pain, tenesmus, pruritus and anal discharge as asse | — |
Countries
Germany
Outcome results
None listed