Health Condition 1: K640- First degree hemorrhoids
Conditions
Interventions
Intervention1: Oryza sativa germinated grain 10% w/w
Limnanthes alba seed oil,
Butyrospermum parkii butter extract 5 % w/w
: 5gm of the single use cream to be applied locally 2 times a day in the ana
Sponsors
Giellepi Spa
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects willing to give written informed consent. 2.Male or female subjects, more than 18 years of age with a diagnosis of haemorrhoids (first or second degree). â?¨ 3.Except haemorrhoids (first or second degree), the subjects are judged to be in good general health, based on medical history, physical examination. â?¨ 4.If female of childbearing age, they should be willing to use an acceptable form of birth control measure. They should be stable since last 3 months prior to baseline â?¨and throughout the study. â?¨ 5.Subjects accepting to be on controlled and balanced diet (with exclusion of â?¨some foods including hot chili, pepper, chocolate, alcoholic drinks, fried foods). Tea and coffee will be restricted to not more of 2 cups per day. 6.Subjects who were on phlebotonic drugs but who are not on the medications since 2 months before the recruitment can be included in the study.
Exclusion criteria
Exclusion criteria: 1.Pregnant and lactating women and women in post-partum period of up to 6 weeks. â?¨ 2.Subjects with a history of permanent anal prolapse and/or anal fissures and/or infective anal pathology. â?¨ 3.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, photocoagulation, cryotherapy etc) within 2 years of enrolment into the trial. â?¨ 4.Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained. â?¨ 5.Subjects with clinically significant co-morbid condition that in the opinion of the investigator could affect the efficacy and safety outcome of the study. â?¨ 6.Patients under treatment with other topical therapy for haemorrhoidal syndrome. 7.Patients under treatment with plebotonic drugs or phlebotonic dietary supplements (i.e. diosmin etc.). 8.Subjects participating in any other clinical trial currently or if he/she has completed the trial participation less than 3 months from screening for the current study. 9.Presence of disease states that could affect safety and efficacy â?¨evaluation, such as hepatic (e.g., cirrhosis with Child-Pugh Class B or C or MELD score > 9), renal (e.g., requiring dialysis), gastrointestinal (e.g., acute or chronic diverticulitis, irritable bowel syndrome with epigastric pain as a predominant symptom or active inflammatory bowel disease), hematologic, neurologic or brain disorders (e.g., strokes, and brain injury), psychiatric (e.g., bipolar disorder, severe active depression, severe active anxiety), or any other significant condition which, in the opinion of the Investigator, could confound or interfere with evaluation of efficacy, safety, or tolerability of the investigational drug, or prevent compliance with the study protocol.â?¨ 10.Subjects unwilling to sign the inform consent document. 11.Any condition that in the opinion of the investigator does not justify the subjectsâ?¨inclusion for the study. 12.Known hypersensitivity to, or intolerance of, investigational product or any excipient. 13.During the course of the study no other medications should be consumed. Only rescue medications to be used with the recommendatuons from the Pricipal Investigtor and this should be recorded in the CRF.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time taken for 35% reduction (compared to baseline) of the overall score (total sum of each individual score of Questionnaires: Appendix G, Appendix H and Appendix I) of active product when compared to placebo.Timepoint: Screening Day 0 7 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Reduction of the score of each symptom at day 7 and 14 . 2.Reduction of the overall score (total sum of each individual score of the following symptoms: pain, tenesmus, pruritus and anal discharge . 3.Number of subjects with complete symptomatic resolution at day 14. 4.Number of subjects with a 35% reduction in the overall symptom score compare to the baseline of active product when compared to placebo. Timepoint: Screening Day 0 7 14 | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Syncretic Clinical Research Services Pvt. Ltd.
Outcome results
None listed