An Open Label, Prospective, Non-Randomised, Non-Comparative, Single Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “Isocure†of Essen Fooddies India Pvt. Ltd. as a Nutritional Supplement in Adult Subjects with Joint Pain.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- 1. WOMAC Scale : Reduction of 20% from baseline
Study Overview
Brief Summary
Study Design : Open Label, Prospective, Non-Randomised,Non-Comparative, Single Arm Clinical Study
Indication : Nutritional Supplement for Adults with Joint Pain
Investigational Product Details Name : Isocure Route of Administration : Oral Formulation : Powdered Nutritional Formulation Dose : 1 sachet (35.71g) in 150ml coldwater Dosage : OD for 3 months
Subject Population : Adult subjects between the ages of 21 and 65 years(both ages and all genders inclusive) with active joint pain.
Treatment Arms : One. Non Comparative Single ArmStudy
Number of Subjects : 50 Subjects
Efficacy Assessments: 1. WOMAC Scale : Day 1, Day 45, Day 90 2. Pain Scale: Day 1, Day 45 Day 90 3. IP Feedback Questionnaire : Day 90
Safety Assessments: 1. Clinical Safety : CBC, Serum Biochemistry 2. Monitoring of Adverse Events
Background of the study: Jointpain is a discomfort that arises from any joints. Joint pain may be due toadvanced age, participation in activities that put pressure in the joint andobesity. The larger prevalence of jointpain among people has impacted their daily activities and the ability to dowork. Current pharamacolgical treatmentsuch as mild painrelievers, like acetaminophen, and nonsteroidal anti-inflammatory drugs, suchas ibuprofen, can provide partial or complete relief of moderate joint andmuscle pain despite their adverse effects onlong-term usage. An alternative treatment with nutritional supplements withhigher levels of safety and effectiveness are needed. Collagen is the most abundant protein found in animalsand is the key structural component in the connective tissues of cartilage,tendons, and ligaments, as well as in a multitude of organs such as bloodvessels, bones, lung, heart, kidney, liver, teeth, and skin. Collagen supplements are intended toreplenish your body’s natural supply of the protein. Dietary intake of collagen peptide has been shown toreduce join pain. In addition, collagen peptide also has been shown to exert abeneficial effect on skin, hair, nail and muscle health.
Purpose of the Study : Isocure by Essen Fooddies comes with the advantage ofhaving collagen peptide as its key component that helps in maintaining healthyjoints and muscles.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 21.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Adult subjects between the ages of 21 and 65 years (both ages and all genders inclusive) with active joint pain.
- •2.Subjects who are willing to abstain from the use of herbal, allopathic or other nutritional supplements that are indicated at improving joint pain, joint and muscle health.
- •3.Subjects who have a pain score of 2-5 on a 10 point VAS at the time of screening in a minimum of one joint.
- •4.Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
- •5.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion Criteria
- •1.Subjects with known hypersensitivity to the ingredients of the investigational product 2.Subjects who are on collagen supplements in any form.
- •3.Subjects who are vegetarians/vegans who object to consumption of animal origin investigational product.
- •4.Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
- •5.Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
- •6.Subjects on remission from cancer of any type less than 5 years at the time of screening 7.Subjects who are planning a pregnancy and/or currently breastfeeding.
- •8.Subjects who have participated in a clinical study less than 1 month before screening.
- •9.Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
- •10.Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •11.Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
Outcomes
Primary Outcomes
1. WOMAC Scale : Reduction of 20% from baseline
Time Frame: 1. WOMAC Scale : Day 1, Day 45, Day 90 | 2. Pain Scale: Day 1, Day 45 Day 90 | 3. IP Feedback Questionnaire : Day 90
2. Pain Scale: Reduction of 20% from baseline
Time Frame: 1. WOMAC Scale : Day 1, Day 45, Day 90 | 2. Pain Scale: Day 1, Day 45 Day 90 | 3. IP Feedback Questionnaire : Day 90
3. IP Feedback Questionnaire : Total Score of 20
Time Frame: 1. WOMAC Scale : Day 1, Day 45, Day 90 | 2. Pain Scale: Day 1, Day 45 Day 90 | 3. IP Feedback Questionnaire : Day 90
Secondary Outcomes
No secondary outcomes reported