Health Condition 1: M255- Pain in joint
Conditions
Interventions
Intervention1: FiColla of Athos Collagen Pvt. Ltd.: Dose : 4 gm in one sachet
Dosage : One sachet to be emptied into 100ml luke warm water, mixed well and consumed immediately.
Treatment Duration : 90
Sponsors
Athos Collagen Private Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 2. 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. 3. 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. 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 participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to the ingredients of the investigational product. Subjects who are on collagen supplements in any form. 2. Subjects who are vegetarians or vegans who object to consumption of animal origin investigational product. 3. Subjects who have active infections diseases or disorder that will prevent them from satisfying the responsibilities of the study. 4. Subjects with a history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc. 5. Subjects remission from cancer of any type less than 5 years at the time of screening 6. Subjects who are planning a pregnancy and or currently breastfeeding. subjects who have participated in a clinical study less than 1 month before screening. 7. 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. 8. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 9. Subjects who in the opinion of the investigator are not eligible for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC :Reduction of Total Score greater than equal to 10 from baseline Pain NRS Scale : Reduction of Total Score greater than equal to 2 from base line Global Rating of change Scale :Reduction of Total Score greater than equal to 2 from base line based on improvement in Xray IP Feedback Questionnaire: Total score greater than or equal to 15 by the end of the study Timepoint: 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicableTimepoint: Not applicable | — |
Countries
India
Contacts
Public ContactDr Sriraam VT
Aurous HealthCare R&D India Pvt. Ltd.
Outcome results
None listed