Health Condition 1: null- Internal Hemorrhoids
Conditions
Interventions
Intervention1: ARWL12 Capsule: Each Capsule contains:
Laiwanti Extract (Mimosa pudica), Nilophar (Nymphae raubra), Neem beei Extract (Azadirachta indica), Suran (Amorphophlauls campanautlus), lsabgol
Sponsors
Welex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Literate males or non-pregnant females, aged 20 to 60 years (both inclusive). 2.Symptomatic internal hemorrhoids, Grades I & II by direct proctoscopic visualization 3.Bleeding from hemorrhoids for at least two days prior to randomization 4.Body mass index of >= 18.5 to 5.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. 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 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.Patients who have known alcohol and drug abuse. 9.Patients who require the use of suppositories. 10.Use of anticoagulants within 30 days prior to Day 1. 11.Patients on anti-platelet agents or low dose aspirin 12.Use of over the counter or prescription anti-hemorrhoid agents (allopathic, herbal, homeopathic, Unani, Siddha medicines) within 14 days prior to Day 1. 13.Patients with blood or urine laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator. 14.Known hypersensitivity to ingredients used in study drug 15.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: 2 months | — |
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 at the end of the treatment 5.Global assessment for overall improvement by physician at the end of the treatment 6.Assessment of pre and post treatment changes in laboratory investigations like LFT RFT Lipid profile CBC ESR Urine Examination Stool Examination and ECG.Timepoint: 2 months | — |
Countries
India
Contacts
Public ContactBhavana Zalavadiya
Target Institute of Medical Education and Research
Outcome results
None listed