Health Condition 1: null- Internal Hemorrhoids
Conditions
Interventions
Intervention1: Piloset Tablet and Piloset Cream: Piloset Tablet: Each Film Coated Tablet Contains Lajjalu Pdr (Mimosa pudica), Nagkesar Pdr (Mesua ferrea), Aralu Ext (Ailanthus excelsa), Seena Ext (Ca
Sponsors
ARJUN HEALTHCARE
Eligibility
Inclusion criteria
Inclusion criteria: 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/m2. 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.
Exclusion criteria
Exclusion criteria: 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. 10. Patients who require the use of suppositories. 11. Use of anticoagulants within 30 days prior to Day 1. 12. 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 1. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects achieving cessation of per rectal bleeding at the end of the treatment 2. Post treatment reduction in severity of bleeding per rectum Timepoint: day -3, day 0, day 15, day 30, day 45 and day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 likeTimepoint: 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 | — |
Countries
India
Contacts
Public ContactDr Nandkishor Borse
Tilak Ayurved Mahavidyalays Seth Tarachand Ramnath Ayurvedic Charitable Hospital
Outcome results
None listed