A Clinical Study to Evaluate Efficacy and Safety of Piloset Tablet Plus Piloset Cream in Patients suffering from Internal Hemorrhoids.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Proportion of subjects achieving cessation of per rectal bleeding at the end of the treatment
研究概览
简要总结
Subjects (male and females, age between 21 to 60 years) attending outpatient department of Shalya tantra and presenting with bleeding per rectum and or other symptoms of hemorrhoids will be subjected to proctoscopic examination to confirm the diagnosis of hemorrhoids, position of hemorrhoids and size of hemorrhoids (Each pile mass will be graded on a scale of 1 to 4, for size and inflammation. Grade 0 size denotes no internal haemorrhoid or flat mucosa. Grade I - small haemorrhoids, without prolapse. Grade 2 - medium size that prolapses and returns spontaneously Grade 3 - large internal haemorrhoids that prolapses but can still be manually reduced. Grade 4- very large internal haemorrhoids and cannot be manually reduced). Subjects with internal hemorrhoids (first and second degree) will be considered for recruitment. A written informed consent will be obtained from subjects for their participation in the study. Subject’s history will be recorded and his/her physical examinations will be done. Subject’s symptoms i.e. bleeding [The severity of bleeding will be assessed by number of bleeding episodes per day over a given week (Before treatment, at each follow up visit and after treatment)]. Bleeding will be considered severe if it occurs more than five times a week, moderate if it occurs three to five times per week and mild if it occurs less than three times per week. Also the quantity of bleeding at each episode of bleeding will be measured. The quantity of bleeding will be measured on 0 to 100 scale, wherein 0 indicates no bleeding and 100 indicates maximum bleeding. Symptoms such as abdominal pain/discomfort (assessment on VAS), constipation (frequency of stool per day), straining on defecation (assessment on VAS), mucus discharge, pruritis (score ranging from 0 -no symptom to 100 - itching all the time and causing severe interruption in routine activities) and pain in the anal region/perineum (assessment on VAS) will be assessed. Assessment of quality of life of subject on WHO quality of life scale will be done on screening visit. Subject will then undergo investigations i.e. fasting blood sugar, CBC, ESR, Hb%, Liver function tests, Renal function tests, Lipid profile, Urine routine and microscopic, Stool Routine and microscopic, Urine pregnancy test (only if the subject is female of child bearing potential), HIV test (I& II), X- ray chest (PA View) and ECG.
A wash out period of 3 days will be advised during which patients will have to refrain from any medication that will have an effect on the digestive system as well as hemorrhoids (allopathic/Herbal /homeopathic etc). At baseline visit, subjects will be given 1 HDPE container of Piloset Tablet (60 Tablets) + 2 tubes of Piloset Cream. Subjects will be advised to take 2 tablets of given medicine twice daily orally after meals for 60 days. Also subjects will be advised to apply sufficient amount of given cream on pile mass twice daily for 60 days. On every follow up visit, except last visit subjects will be provided study medications. Drug compliance will be assessed by the investigator on each follow up visit and at the end of the study. Assessment of quality of life of subject on WHO quality of life scale will be done on baseline visit.
Subjects will undergo general and systemic examinations. At baseline visit and on every follow up visit (except last follow up visit), subjects will be provided with diary card to record daily symptoms of hemorrhoids. On every follow up visit, filled diary card will be collected and symptoms will be assessed and graded on clinical symptom scoring scale.
Subjects will be called to the study center for follow up visits on every 15th day till 60 days after the baseline visit. On every follow up visit, subjects will undergo general and systemic examinations. Assessment of clinical symptoms will also be done on every follow up visit. On every follow visit, proctoscopic examination will be done for evaluation of position and size of hemorrhoids. Assessment of pile mass will be done on every follow up visit. Also assessment of quality of life of patients on WHO quality of life scale will be done on day 30 and at the end of study i.e. on day 60. Patient’s global evaluation for overall improvement and Investigator’s global evaluation for overall improvement will be done on completion of the study. Tolerability of the trial drugs will be assessed by the investigator and by the patient at the end of the trial. All the patients will be closely monitored for any Adverse Events starting from baseline visit till the end of the study visit. On final follow up visit (i.e. Day 60), subject’s laboratory investigations (viz. CBC, ESR, Hb%, Liver function tests, Renal function tests, Lipid profile, Stool Routine & Microscopic, Urine routine & microscopic, and ECG will be performed. After completion of 60 days of study treatment, all the subjects will be asked to stop trial medications and take advice of investigator for further treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males or non-pregnant females, aged 21 to 60 years (both inclusive).
- •2.Subjects ready to refrain from any allopathic, Ayurvedic, homeopathic, Siddha, Unani drug(s) or any other traditional or folklore medicine for hemorrhoids or for constipation during washout period (3 days) 3.Symptomatic internal hemorrhoids, Grades I & II by direct proctoscopic visualization 4.Bleeding from hemorrhoids for at least two days prior to randomization 5.Body mass index of greater than or equal to 18.5 to less than or equal to 36 kg/m
- •6.Females of child bearing potential who agree to use contraception.
- •7.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •1.Patients with protruding or irreducible hemorrhoids (grade III & IV).
- •2.Patients with anal fistulas, periproctitis or hemorrhagic diathesis 3.Patients with current history of Type I or Type II diabetes mellitus.
- •4.Patients with severe hepatic, renal or cardiovascular disorders.
- •5.Patients with any type of infectious disease.
- •6.Patients who have been involved with another experimental drug trial within the past 30 days.
- •7.Patients presently diagnosed with cancer.
- •8.Subjects of female gender or non-pregnant, non-lactating females, at least six weeks postpartum.
- •A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
- •9.Patients who have known alcohol and drug abuse.
- •11.Use of anticoagulants within 30 days prior to Day
- •Patients on anti-platelet agents or low dose aspirin 13.Use of over the counter or prescription anti-hemorrhoid agents (allopathic, herbal, homeopathic, Unani, Siddha medicines) within 14 days prior to Day
- •14.Patients with blood or urine laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator.
- •15.Known hypersensitivity to ingredients used in study drug 16.Pregnant and Lactating females.
结局指标
主要结局
1. Proportion of subjects achieving cessation of per rectal bleeding at the end of the treatment
时间窗: day -3, day 0, day 15, day 30, day 45 and day 60
2. Post treatment reduction in severity of bleeding per rectum
时间窗: day -3, day 0, day 15, day 30, day 45 and day 60
次要结局
- 1.Post treatment reduction in pile mass 2.Post treatment reduction in other symptoms of hemorrhoids 3.Improvement in Quality of Life at the end of the treatment 4.Global assessment for overall improvement by patient and Physician on day 60 5.Assessment for tolerability of Trial drugs by patient and by physician 0n day 60. 6.Assessment of pre and post treatment changes in laboratory investigations like(Outcome no 1 and 2: day -3, day 0, day 15, day 30, day 45 and day 60 Out Come No 3:day 0, day 30, and day 60 Outcome No. 4 & 5: day 60 Outcome no. 6: day -3 and day 60)