An Open Label, Prospective, Non-Randomised, Non-Comparative Single Arm Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “FiColla†from Athos Collagen Private Limited as a Nutritional Supplement in Adult Subjects with Joint Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- WOMAC :Reduction of Total Score greater than equal to 10 from baseline
研究概览
简要总结
Study Design : Open Label, Prospective ,Non Randomized ,Non Comparative Single Arm Clinical Study
Indication : Pain in Unspecified Joint
Investigational Product : FiColla
Comparator: Not Applicable .Single Arm Non Comparative Study
Dose/Dosage Dose: 4gm in One sachet. Dosage: One sachet to be emptied into 100 ml luke warm water, mixed well and consumed immedaitely for 90 days
Subject Population : Adult subjects between the ages of 35 and 65 years both ages and all genders inclusive with unspecified joint pain not attributed to a specific diseases or disorder
Number of Subjects : 30 Evaluable Subjects
Treatment Arms: I
Treatment Duration: 90 days
Efficacy Assessments 1. Pain NRS : Day 1, Day 45, Day 9 **2.**WOMAC: Day 1, Day 45,Day 90 3. Global Rating of Change Scale: Day 90 4. IP feedback Questionnaire: Day 90
Safety Assessments 1. Clinical Safety: CBC, Serum Biochemistry 2. Monitoring of Adverse Events
Background of the study: Pain is the most common and compelling reason for seeking medical care. Patients seek medical care for evaluation and symptom relief of pain because it interferes with activities of daily living,causes emotinal distress and resuts in lack of confidence in ones health.
Purpose of the Study : FiColla is a marine collagen supplement, fish collagen peptide exerts a possitive effect on collagen synthisis, collagen quality and matrix mineralization in an osteoblastic cell culture system, likely by upregulating the gene expression of the respective collagen modifying enzymes. This suggests the potential utility of FCP as a biomaterial for bone healing and regeneration.
FiColla is a 100 percent fish collagen peptide from Athos Collagen Pvt.Ltd. that is aimed at effectively treatment for joint pain in adults
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult subjects between ages of 35 and 66 years both ages and all genders inclusive with active joint pain not attributed to a specific diseases or disorder
- •Subjects who have a pain score of 5 to 7 on a 10 point NRS at time of screening in a minimum of one joint.
- •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.
- •Subjects who are willing to give informed consent for participation , able to comprehend and understand the responsibilities during screening and treatment period.
- •Subjects who are willing not to participation in the current trial.
排除标准
- •Subjects with known hypersensitivity to the ingredients of the investigational product.
- •Subjects who are on collagen supplements in any form.
- •Subjects who are vegetarians or vegans who object to consumption of animal origin investigational product.
- •Subjects who have active infections diseases or disorder that will prevent them from satisfying the responsibilities of the study.
- •Subjects remission from cancer of any type less than 5 years at the time of screening
- •Subjects who are planning a pregnancy and or currently breastfeeding.
- •subjects who have participated in a clinical study less than 1 month before screening.
- •Any significant medical condition such as significant psychiatric or neurological disorders, active alcohol or drug abuse etc.
- •any medical condition that is unstable or poorly controlled or other factor e.g., planned relocation that the investigator felt would interfere with study evaluations and study participation.
- •Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •Subjects who in the opinion of the investigator are not eligible for enrollment in the study.
结局指标
主要结局
WOMAC :Reduction of Total Score greater than equal to 10 from baseline
时间窗: WOMAC: Day 1,Day 45,day 90 | Pain NRS Scale: Day 1,Day 45,Day 90 | Global Rating of Change scale: Day 90 | IP Feedback Questionnaire: Day 90
Pain NRS Scale : Reduction of Total Score greater than equal to 2 from base line
时间窗: WOMAC: Day 1,Day 45,day 90 | Pain NRS Scale: Day 1,Day 45,Day 90 | Global Rating of Change scale: Day 90 | IP Feedback Questionnaire: Day 90
Global Rating of change Scale :Reduction of Total Score greater than equal to 2 from base line based on improvement in Xray
时间窗: WOMAC: Day 1,Day 45,day 90 | Pain NRS Scale: Day 1,Day 45,Day 90 | Global Rating of Change scale: Day 90 | IP Feedback Questionnaire: Day 90
IP Feedback Questionnaire: Total score greater than or equal to 15 by the end of the study
时间窗: WOMAC: Day 1,Day 45,day 90 | Pain NRS Scale: Day 1,Day 45,Day 90 | Global Rating of Change scale: Day 90 | IP Feedback Questionnaire: Day 90
次要结局
- Not applicable(Not applicable)