CTRI/2014/01/004300
Completed
Phase 2
A Clinical Study to Evaluate Efficacy and Safety of Piloset Tablet Plus Piloset Cream in Patients suffering from Internal Hemorrhoids. - NI
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Internal Hemorrhoids
- Sponsor
- ARJUN HEALTHCARE
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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