Health Condition 1: K641- Second degree hemorrhoids
Conditions
Interventions
Intervention1: Aloe Barbadensis Leaf Juice 10X Decolorized
Olio Jojoba Golden: 5gm of the cream to be applied locally 2 times a day in the anal region for 14 days.
Control Intervention1: Nil: Nil
Sponsors
Giellepi Spa
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects willing to give written informed consent. 2. Male or female subjects, between 18 years of age and 70 years age with a diagnosis of haemorrhoids (first or second degree). 3. Except hemorrhoids (first or second degree), the subjects are judged to be in good general health, based on medical history, physical examination. 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 and throughout the study. 5. Subjects accepting to be on controlled and balanced diet (with exclusion of 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.
Exclusion criteria
Exclusion criteria: 1.Pregnant and lactating women and women in post-partum period of up to 6 weeks. 2. Subjects with a history of permanent anal prolapse and/or anal fistula 3. Subjects with associated anal fissures and/or infective anal pathology. 4. 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. 5. Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained. 6. Subjects with clinically significant co-morbid condition that in the opinion of the investigator could affect the efficacy and safety outcome of the study. 7. Patients under treatment with other topical therapy for haemorrhoidal syndrome. 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 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. 10. Subjects unwilling to sign the inform consent document. 11. Any condition that in the opinion of the investigator does not justify the subjects inclusion for the study. 12. Known hypersensitivity to, or intolerance of, investigational product or any excipient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in the following subjective symptoms: pain, tenesmus, pruritus and anal discharge. 2.Improvement of pain during defecation 3.Change in overall assessment of disease as assessed by the subject on a 10 cm Visual Analogue Scale (VAS). 4.Change in the following objective signs: Congestion, oedema, and exudation 5.Overall treatment satisfaction questionnaire.Timepoint: Screening, Day 0,7 and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Physical Examination: Examination includes areas such as perianal skin should be assessed. 2.Any reports of adverse or serious adverse events during the treatment period. 3.Significant change in laboratory parameters Any abnormal vital signs.Timepoint: Screening, Day 0,7 and 14 | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Syncretic Clinical Research Services Pvt Ltd
Outcome results
None listed